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Intrivo Diagnostics Secures National Distribution Agreement with McKesson Medical-Surgical for Access Bio CareStart™ COVID-19 Tests

Intrivo Diagnostics Secures National Distribution Agreement with McKesson Medical-Surgical for Access Bio CareStart™ COVID-19 Tests 150 150 Victor Espinoza

Intrivo Diagnostics Secures National Distribution Agreement with McKesson Medical-Surgical for Access Bio CareStart™ COVID-19 Tests

Additional agreement that expands Intrivo’s family of authorized distributors will ensure broad access to rapid testing solutions across US

 

Intrivo Diagnostics, a Los Angeles-based diagnostic testing provider for high-quality testing solutions for COVID-19, today announced that it will begin national distribution and commercialization of diagnostic testing products developed by New Jersey-based testing manufacturer, Access Bio, Inc. through McKesson Medical-Surgical. McKesson joins Concordance Healthcare Solutions and NDC, Inc. as key national partners within the Healthcare Supply Chain to help bring the CareStart™ line of COVID-19 testing products to the US market.

“Our agreement with McKesson Medical-Surgical is a monumental step in our efforts to reopen America through the use of rapid testing on a mass scale. By enhancing our supply chain to ensure greater access to Access Bio’s testing products, we can play a large role in curbing the spread of this virus,” said Reeve Benaron, Founder, Chairman and CEO, Intrivo Diagnostics. “We are delighted to welcome McKesson to our family of authorized distributors.”

As Access Bio’s exclusive US commercialization partner, Intrivo’s new channel agreements will expand the supply chain for the CareStart™ line of COVID-19 testing products across the country, ensuring greater access to testing supplies for healthcare providers and organizations. To date, Access Bio has received FDA Emergency Use Authorization (EUA) for its RT-PCR testIgM/IgG antibody test and most recently, a rapid point-of-care (POC) antigen test.

The CareStart™ COVID-19 antigen test is a lateral-flow immunochromatographic assay capable of producing results within 10 minutes of being administered with 88.4% sensitivity and 100% specificity. The test is a self-contained, single-use product designed to detect extracted nucleocapsid protein antigens specific to SARS-CoV-2 in nasopharyngeal specimens collected from individuals suspected of being infected with COVID-19 or exposed to COVID-19. The assay includes a swab, a vial of extraction solution and a cassette the size of a small flash drive. A positive test result is indicated by a visible line in the cassette and doesn’t require any special technical training to use. Each kit can administer up to 20 antigen tests.

McKesson Medical-Surgical Inc. is an affiliate of the McKesson Corporation. McKesson Corporation is a global leader in healthcare supply chain management solutions, retail pharmacy, community oncology and specialty care, and healthcare information solutions. From providing technologies and delivery solutions, to contract and sales support, their involvement will help Intrivo Diagnostics and Access Bio guarantee delivery of CareStart™ testing solutions safely and cost-effectively throughout the US.

“Testing will continue to remain a key element in America’s fight against COVID-19,” said Mr. Young H. Choi, Chairman and CEO, Access Bio. “Our goal is to enhance our supply chain to ensure greater access to our products. Our tests are critical in providing diagnosis, tracing and curbing the pandemic’s spread to help America regain a sense of normalcy.”

Established in 2002, Access Bio has a proven track record of releasing top-performing products, including its CareStart™ Malaria Rapid Diagnostic Test (RDT).

Access Bio distributes its products to more than 120 countries around the world, thanks to scalable infrastructure consisting of R&D and production facilities in the United States, South Korea and Ethiopia. Access Bio is traded on the Korean Stock Exchange (KRX) under the stock symbol, KR: 950130.

For more information about Access Bio and the CareStart™ COVID-19 line of products, please visit: https://accessbiodiagnostics.net/

For more information about Intrivo Diagnostics, please visit: https://intrivo.com/

Intrivo Diagnostics Inks National Distribution Agreements with Concordance Healthcare Solutions and NDC for Access Bio CareStart™ COVID-19 Tests

Intrivo Diagnostics Inks National Distribution Agreements with Concordance Healthcare Solutions and NDC for Access Bio CareStart™ COVID-19 Tests 150 150 Victor Espinoza

Intrivo Diagnostics Inks National Distribution Agreements with Concordance Healthcare Solutions and NDC for Access Bio CareStart™ COVID-19 Tests

Major supply chain agreements will ensure broad access to rapid testing solutions for patients and healthcare providers across US

 

Intrivo Diagnostics, a Los Angeles-based diagnostic testing provider committed to addressing the urgent demand for high-quality testing solutions for COVID-19, today announced that it will begin national distribution and commercialization of diagnostic testing products developed by New Jersey-based testing manufacturer, Access Bio, Inc. through Concordance Healthcare Solutions and NDC, Inc.

As Access Bio’s exclusive US commercialization partner, Intrivo’s new channel agreements will expand the supply chain for the CareStartTM line of COVID-19 testing products across the country, ensuring greater access to testing supplies for healthcare providers and organizations. To date, Access Bio has received FDA Emergency Use Authorization (EUA) for its RT-PCR testIgM/IgG antibody test and most recently, a rapid point-of-care (POC) antigen test.

“These are landmark agreements for Access Bio and Intrivo, as well as for healthcare providers and their patients in need of high-quality testing,” said Reeve Benaron, Founder, Chairman and CEO, Intrivo Diagnostics. “With the help of our new channel partners, we can dramatically broaden the reach and distribution of our CareStart portfolio, ensuring that healthcare workers and patients have easy access to rapid testing solutions like point-of-care antigen, to diagnose, trace and curb the pandemic’s spread in the name of public health.”

The CareStartTM COVID-19 antigen test is a lateral-flow immunochromatographic assay capable of producing results within 10 minutes of being administered with 88.4% sensitivity and 100% specificity. The test is a self-contained, single-use product designed to detect extracted nucleocapsid protein antigens specific to SARS-CoV-2 in nasopharyngeal specimens collected from individuals suspected of being infected with COVID-19 or exposed to COVID-19. The assay includes a swab, a vial of extraction solution and a cassette the size of a small flash drive. A positive test result is indicated by a visible line in the cassette and doesn’t require any special technical training to use. Each kit can administer up to 20 antigen tests.

Concordance Healthcare Solutions and NDC, Inc. are proven leaders in distributing medical and laboratory products throughout the continuum of care. From providing technologies and delivery solutions, to contract and sales support, their involvement will help Intrivo Diagnostics and Access Bio guarantee delivery of CareStartTM testing solutions safely and cost-effectively throughout the US.

“Testing remains an invaluable tool in America’s fight against COVID-19,” said Mr. Young H. Choi, Chairman and CEO, Access Bio. “By enhancing our supply chain to ensure greater access to our products, we’re confident that our company can play a vital role in helping restore a sense of normalcy to the US. Our tests will not only continue to be critical in diagnosing COVID-19 exposure, but also in corroborating vaccine efficacy as deployment gets underway in 2021.”

Established in 2002, Access Bio has a proven track record of releasing top-performing products, including its CareStartTM Malaria Rapid Diagnostic Test (RDT).

Access Bio distributes its products to more than 120 countries around the world, thanks to scalable infrastructure consisting of R&D and production facilities in the United States, South Korea and Ethiopia. Access Bio is traded on the Korean Stock Exchange (KRX) under the stock symbol, KR: 950130.

For more information about Access Bio and the CareStartTM COVID-19 line of products, please visit: https://accessbiodiagnostics.net/

For more information about Intrivo Diagnostics, please visit: https://intrivo.com/

Announcement of the Record Date for Determining Shareholders

Announcement of the Record Date for Determining Shareholders 150 150 Victor Espinoza

Announcement of the Record Date for Determining Shareholders

Emergency Use Authorization Granted for CareStartTM Point-Of-Care Kit

December 14, 2020 — In accordance with Article 16 (1) of the “Korean Depository Receipt Agreement” signed between Access Bio and Korea Securities Depository on March 11, 2013, the Record Date for determining shareholders in 2020 is December 31, 2020. Voting rights for the 2020 Annual Meeting of Shareholders will be granted to the shareholders listed in the register of a real shareholder of the Korea Securities Depository. Please be notified that it is not possible to convert between KDR (Korean Depository Receipts) and original stocks during December 31, 2020 to January 31, 2021.

Access Bio is traded on the Korean Stock Exchange (KRX) under the stock symbol, KR: 950130, and we are notifying the following in Korean for Korean shareholders as below.

제목: 제19기 정기주주총회 권리주주 확정을 위한 증권예탁증권 기준일 설정 공고
내용: 엑세스바이오 제19기 정기주주총회 권리주주 확정을 위한 증권예탁증권 기준일 설정 공고입니다.

제목

제19기 정기주주총회 권리주주 확정을 위한 증권예탁증권 기준일 설정 공고

주요내용

Access Bio, Inc. 및 한국예탁결제원간 2013년 3월 11일 체결한 예탁계약서 제16조1항에 의거하여 아래 <1> 증권예탁증권(KDR) 기준일 현재(2020년 12월 31일) 한국예탁결제원의 실질소유자명부에 기재되어 있는 소유자에게 의결권을 부여하며, <2>의 기간 중 증권예탁증권과 주식간의 전환이 불가함을 공고합니다.
-아래-
<1> 의결권행사 소유자확정을 위한 증권예탁증권(KDR) 기준일 : 2020년 12월 31
<2> 증권예탁증권(KDR)과 주식 간 전환 제한기간 : 2020년 12월 31일부터 2021년 1월 31일까지

결정(확인)일자

2020-12-14

기타 투자판단에 참고할 사항

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관련공시

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Access Bio Granted Emergency Use Authorization by FDA for CareStartTM COVID-19 IgM/IgG Antibody Test

Access Bio Granted Emergency Use Authorization by FDA for CareStartTM COVID-19 IgM/IgG Antibody Test 150 150 Victor Espinoza

Access Bio Granted Emergency Use Authorization by FDA for CareStartTM COVID-19 IgM/IgG Antibody Test

Global Leader in Infectious Disease Diagnosis Receives FDA EUA for Serology Test Capable of Determining Subjects’ past COVID-19 Exposure and Immunoresponse within 10 Minutes

August 4, 2020 (SOMERSET, NJ) — Access Bio, Inc., a longstanding leader in the development of diagnostic tests for infectious diseases through research, development, and manufacturing, today announced that the U.S. Food and Drug Administration (FDA), has granted the company Emergency Use Authorization (EUA) for its CareStartTM COVID-19 IgM/IgG antibody test. This lateral flow antibody test represents the first of its kind to be truly 100% manufactured in the U.S.A.

Manufactured entirely in the United States, the CareStartTM COVID-19 IgM/IgG test is a rapid SARS CoV-2 lateral flow immunochromatographic assay, designed to indicate past exposure to, and infection by the novel coronavirus (SARS-CoV-2). Access Bio’s serology test detects and differentiates IgM and IgG antibodies in human blood specimens with combined 98.4% sensitivity and 98.9% specificity. Healthcare providers administering the test only require a small sample volume (10 uL) of whole blood via a finger lancet and may be used with serum or plasma as well. Results are then determined within a 10-minute window.

Additionally, the CareStartTM COVID-19 IgM/IgG from Access Bio was tested in an independent clinical study on Jun 2, 2020, at the Frederick National Laboratory for Cancer Research (FNLCR) sponsored by the National Cancer Institute (NCI) and was found to have 100% sensitivity and 97.5% specificity.

“COVID-19’s rapid spread throughout the United States was unprecedented and left our country reeling, and lacking adequate testing and tracing solutions,” said Young H. Choi, President, and CEO, Access Bio. “Our serology test’s performance and quality will help scale mass determination of COVID-19 exposure while offering an unrivaled new tool for helping trace and curb the pandemic’s spread.”

Each CareStartTM COVID-19 IgM/IgG antibody test kit includes: test devices, assay buffer vial, blood transfer pipettes, and package insert and can administer up to 25 antibody tests per kit. The CareStartTM COVID-19 IgM/IgG test is the second COVID-19 test kit from Access Bio to receive EUA authorization from the FDA after its CareStartTM MDx RT-PCR test. Tests will be distributed in partnership with Intrivo Diagnostics, which will act as a resource for qualified healthcare professionals.

“The availability of the CareStartTM COVID-19 IgM/IgG test kit brings needed Covid-19 antibody diagnostic testing to millions of patients across the U.S. and world during the current pandemic,” said Michael Harbour, MD, MPH, Chief Medical Officer, Intrivo Diagnostics. “These high-quality tests are manufactured in the U.S. by Access Bio, a company with a long history of engineering and manufacturing superior quality diagnostic kits for malaria, dengue, typhus, and other infectious diseases.”

Established in 2002, Access Bio has a proven track record of releasing top-performing products, including its CareStartTM Malaria Rapid Diagnostic Test (RDT). Access Bio’s molecular technologies help diagnose infection and disorders using genetic information, such as DNA and RNA to obtain more accurate diagnoses compared to conventional immunological or biochemical diagnostic products.

Access Bio distributes its products to more than 120 countries around the world, thanks to scalable infrastructure consisting of R&D and production facilities in the United States, South Korea, and Ethiopia. Access Bio is traded on the Korean Stock Exchange (KRX) under the stock symbol, KR: 950130.

For more information about Access Bio and the CareStartTM COVID-19 IgM/IgG test, please visit https://www.carestart.com.

About Access Bio:
Access Bio was founded by Young Ho Choi in 2002 in Somerset, New Jersey, and quickly established itself as a long-standing global leader in diagnostic testing, striving to create a foundation of well-being for all people. With a history of creating revolutionary products, such as the CareStartTM Malaria Rapid Detection Test, Access Bio remains a leader in accurate, sustainable, and cost-effect diagnosis solutions.

About Intrivo Diagnostics:
Headquartered in Los Angeles, CA, Intrivo Diagnostics is an organization driven by science and dedicated to providing accurate and easy-to-use diagnostic testing to save lives and slow the spread of infectious diseases. Intrivo Diagnostics’ mission is to distribute exceptional products to address the urgent demand for high-quality diagnostic testing. In keeping with that mission, Intrivo Diagnostic is the exclusive distribution partner for Access Bio, Inc.’s CareStartTM line of COVID-19 testing products, all of which are solely manufactured in the USA.

FDA Greenlights Access Bio’s 10-Minute COVID-19 Antigen Test

FDA Greenlights Access Bio’s 10-Minute COVID-19 Antigen Test 150 150 Yvette Gharemanian

FDA Greenlights Access Bio’s 10-Minute COVID-19 Antigen Test

Emergency Use Authorization Granted for CareStartTM  Point-Of-Care Kit

October 13, 2020 (SOMERSET, NJ)Access Bio, Inc., a New Jersey-based leader in the development and manufacturing of diagnostic tests for infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its COVID-19 CareStartTM Antigen rapid test.

“This rapid antigen test may be the key to reopening schools and businesses,” said Mr. Young H. Choi, Chairman and CEO, Access Bio. “Within minutes of administering this inexpensive, U.S.-made test, a healthcare provider will better know whether or not a patient is infected.”

Access Bio has an 18-year track record of engineering and manufacturing superior-quality diagnostic kits for malaria, dengue, influenza and other infectious diseases. 

The new rapid antigen test is fast and easy to administer in a point-of-care setting and can be conducted by nasopharyngeal (NP) swab by non-laboratory medical professionals. Access Bio’s rapid antigen test requires no additional equipment or special instrument for sample analyses, and results are visually read onsite in 10 minutes. 

“This is a major breakthrough that has the potential to bring our daily lives back to normal,” said Reeve Benaron, Founder, Chairman and CEO, Intrivo Diagnostics, the exclusive distributor of the tests, “Because our rapid Antigen test does not require an instrument or machine, this means the test can be used anytime, anywhere. We’re confident that our test is a game-changer because it can be mass produced and is inexpensive enough to be widely used by healthcare professionals in schools, at large gatherings, and in office buildings.” 

The CareStartTM COVID-19 antigen test is a lateral-flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in nasopharyngeal specimens collected from individuals suspected of being infected with COVID-19 or exposed to COVID-19. Clinical validations are showing results of 88.4% sensitivity and 100% specificity. It is the third test from Access Bio to receive EUA authorization from the FDA after its CareStartTM COVID-19 RT-PCR test and CareStartTM COVID-19 IgM/IgG antibody rapid test. Access Bio is now one of only two companies in the world to receive FDA EUA authorization for all available testing products on the market: RT-PCR, antibody, and antigen.

Each CareStartTM COVID-19 antigen test kit includes test devices, assay buffer, extraction vials and caps, specimen collection swabs, positive and negative control swabs, and instructions. Each kit can administer up to 20 antigen tests. 

For more information about Access Bio and the CareStartTM COVID-19 Antigen test, please visit: https://www.carestartantigen.com.

About Access Bio:
Access Bio, headquartered in New Jersey, was founded by Mr. Young H. Choi in 2002. The company has a proven track record of releasing top-performing products, including its CareStartTM Malaria Rapid Diagnostic Test (RDT), which commands 60 percent of the global malaria testing market share. Access Bio distributes its products to more than 120 countries around the world, thanks to scalable infrastructure consisting of R&D and production facilities in the U.S., South Korea, and Ethiopia. Access Bio is traded on the Korean Stock Exchange (KRX) under the stock symbol, KR: 950130.

About Intrivo Diagnostics:
Headquartered in Los Angeles, Intrivo Diagnostics is an organization driven by science and dedicated to providing sophisticated and accurate diagnostic testing to save lives and slow the spread of infectious diseases. Intrivo Diagnostics’ mission is to distribute exceptional products to address the urgent demand for high-quality diagnostic testing. In keeping with that mission, Intrivo Diagnostic is the exclusive distribution partner for Access Bio, Inc.’s CareStartTM line of COVID-19 testing products, all of which are solely manufactured in the U.S.

Privacy Policy

Privacy Policy 150 150 axadmin

Privacy Policy

Protecting your private information is our priority. This Privacy Policy applies to accessbio.net (the “Site”) and describes the data and information Access Bio, Inc. (“Access Bio) may collect from you or that you may provide when you visit the Site. This Privacy Policy governs Access Bio’s practices related to data collection and usage. For the purposes of this Privacy Policy, unless otherwise noted, all references to Access Bio include accessbio.net and Access Bio.

This Privacy Policy is part of and incorporated into the Terms and Conditions, found at accessbio.net/terms-and-conditions/ which is a legally binding agreement between you and Access Bio. By using the Access Bio website, you consent to the data practices described in this statement.

Collection of your Personal Information

In order to better provide you with the products and services offered on the Site, Access Bio may collect personally identifiable information, such as your:

  • First and Last Name
  • Mailing Address
  • Email Address
  • Phone Number

If you purchase Access Bio’s products and services, we will collect billing and credit card information. This information is used to complete the purchase transaction.

Please keep in mind that if you directly disclose personally identifiable information or personally sensitive data through Access Bio’s public message boards, this information may be collected and used by others.

We do not collect any personal information about you unless you voluntarily provide it to us. However, you may be required to provide certain personal information to us when you elect to use certain products or services available on the Site. These may include: (a) registering for an account on our Site; (b) entering a sweepstake or contest sponsored by us or one of our partners: (c) signing up for special offers from selected third parties; (d) sending us an email message; (e) submitting your credit card or other payment information when ordering and purchasing products and services on our Site. To wit, we will use your information for, but not limited to, communicating with you in relation to services and/or products you have requested from us. We also may gather additional personal or non-personal information in the future.

Use of your Personal Information

Access Bio collects and uses your personal information to operate its website(s) and deliver the services you have requested. Access Bio may use your personal information to:

  • offer and provide information and services to you
  • communicate with you about, and administer your participation in, surveys, events, programs, newsletters, promotions, and other Site features;
  • respond to and communicate with you about your inquiries and requests, and provide Services, information, and products you request;
  • send periodic emails to market and promote our products and
  • Services and for non-marketing or administrative purposes; and
  • operate, evaluate and improve our business (including developing new products and services; enhancing and improving our services; managing our communications; analyzing our products; targeting advertising for our products; performing data analytics; and performing accounting, auditing, billing reconciliation, and collection activities and other internal functions). Access Bio may also use your personal information to inform you of other products or services available from Access Bio and its affiliates.
Sharing Information with Third Parties

Access Bio does not sell, rent, or lease its customer lists to third parties. Access Bio may, from time to time, contact you on behalf of external business partners about a particular offering that may be of interest to you. In those cases, your unique personally identifiable information (e.g., e-mail, name, address, telephone number) is not transferred to the third party.

Access Bio may share data with trusted third-party service provider partners to help perform statistical analysis, send you email or postal mail, provide customer support, or arrange for deliveries. All such third parties are prohibited from using your personal information except to provide these services to Access Bio or comply with legal requirements, and they are required to maintain the confidentiality of your information.

Access Bio may disclose your personal information, without notice, if required to do so by law or in the good faith belief that such action is necessary to (a) conform to the edicts of the law or comply with legal process served on Access Bio or the Site; (b) protect and defend the rights or property of Access Bio; and/or (c) act under exigent circumstances to protect the personal safety of users of Access Bio or the public. We reserve the right to transfer any information we have about you in the event we sell, transfer, or merge all or a portion of our business or assets (including in the event of a reorganization, dissolution or liquidation).

Tracking User Behavior

Access Bio may keep track of the websites and pages our users visit within the Site, in order to determine what Access Bio services are the most popular. This data is used to deliver customized content and advertising within Access Bio to customers whose behavior indicates that they are interested in a particular subject area.

Automatically Collected Information

Information about your computer hardware and software may be automatically collected by Access Bio when you visit the Site. This information can include your IP address, browser type, domain names, access times, and referring website addresses. This information is used for the operation of the service, to maintain quality of the service, and to provide general statistics regarding use of the Site.

Use of Cookies

The Site may use “cookies” to help personalize your online experience. A cookie is a text file that is placed on your hard disk by a web page server. Cookies cannot be used to run programs or deliver viruses to your computer. Cookies are uniquely assigned to you, and can only be read by a web server in the domain that issued the cookie to you.

One of the primary purposes of cookies is to provide a convenience feature to save you time. The purpose of a cookie is to tell the web server that you have returned to a specific page. For example, if you personalize Access Bio pages, or register with Access Bio site or services, a cookie helps Access Bio to recall your specific information on subsequent visits. This simplifies the process of recording your personal information, such as billing addresses, shipping addresses, and so on. When you return to the same Access Bio website, the information you previously provided can be retrieved, so you can easily use the Access Bio features that you customized.

You have the ability to accept or decline cookies. Most Web browsers automatically accept cookies, but you can usually modify your browser setting to decline cookies if you prefer. If you choose to decline cookies, you may not be able to fully experience the interactive features of the Access Bio services or websites you visit.

Links

For your convenience, the Site may contain links to other websites. Please be aware that Access Bio is not responsible for the content or privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of any other site that collects personally identifiable information.

Children Under Thirteen

Access Bio does not knowingly collect personally identifiable information from children under the age of thirteen. If you are under the age of thirteen, you must ask your parent or guardian for permission to use this website.

E-mail Communications

From time to time, Access Bio may contact you via email for the purpose of providing announcements, promotional offers, alerts, confirmations, surveys, and/or other general communication. In order to improve our Services, we may receive a notification when you open an email from Access Bio or click on a link therein.

External Data Storage Sites

We may store your data on servers provided by third party hosting vendors with whom we have contracted.

Protecting Your Information

We take reasonable and appropriate measures to protect your information from accidental, unlawful, or unauthorized destruction, loss, alteration, access, disclosure, or use. We implement certain physical, administrative, and technical safeguards that are designed to protect the integrity and security of your information.

Unfortunately, no methods used to transmit information via the internet or methods of data storage are completely secure. Although we do our best to protect your information, we cannot guarantee that information may not be accessed, disclosed, altered, or destroyed by a breach of any of our physical, technical, or administrative safeguards. Any transmission of information is at your own risk. You agree that Access Bio is not liable for the unauthorized release of your information unless such release was the result of gross negligence or willful misconduct on the part of Access Bio.

Geographic Restriction

Our Site is intended to comply with the laws and regulations of the United States of America. We make no representations that our Site is appropriate or available for use in any location outside of the United States. If you are a resident of another country or are accessing the Site from outside of the United States, please note that you are transferring your data to the United States of America which does not have the same data protection laws as the European Union and other regions.

Privacy Notice for California Residents

This Privacy Notice for California Residents supplements the information contained in the balance of our Privacy Policy and applies solely to all visitors, users, and others who reside in the State of California (“consumers” or “you”). We adopt this notice to comply with the California Consumer Privacy Act of 2018 (CCPA) and any terms defined in the CCPA have the same meaning when used in this notice. 

Information We Collect

We collect information that identifies, relates to, describes, references, is reasonably capable of being associated with, or could reasonably be linked, directly or indirectly, with a particular consumer, household or device (“personal information”). Personal information does not include:

  • Publicly available information from government records.
  • Deidentified or aggregated consumer information.
  • Information excluded from the CCPA’s scope, like:
  • health or medical information covered by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the California Confidentiality of Medical Information Act (CMIA) or clinical trial data;
  • personal information covered by certain sector-specific privacy laws, including the Fair Credit Reporting Act (FRCA), the Gramm-Leach-Bliley Act (GLBA) or California Financial Information Privacy Act (FIPA), and the Driver’s Privacy Protection Act of 1994.

In particular, we have collected the following categories of personal information from its applicants within the last twelve (12) months: 

Category

Examples

Collected

A.Identifiers.

A real name, postal address, unique personal identifier, oline identifier, Internet protocal address, email address, account name, Social Security number, driver's license number, passport number, or other similar identifiers.

YES

B. Personal information categories listed in the California Customer Records statute (Cal. Civ. Code § 1798.80(e)).

A name, signature, Social Security number =, physical characteristics or description, address, telephone number, passport number, driver's license or state Identification card number, insurance policy number, education, employment, employment history, bank account number, credit card number, debit card number, or any other financial information, medical information, or health insurance information.

Some personal information included in this category may overlap with other categories

YES

C.Protected classification characteristics
under California or federal law.

Age (40 years or older), race, color, ancestry, national origin, citizenship, religion or creed, marital status, medical condition, physical or mental disability, sex (including gender, gender identity, gender expression, pregnancy or childbirth and related medical condition), sexual orientation, veteran or military staus, genitic information (including familial genitic information).

YES

D. Commercial information

Records or personal property, products or services purchased, obtained, or considered, or other purchasing or consuming histpries or tendencies.

YES

E. Biometric information.

Genitic, physiological, behavioral, and biological characteristic, or activity patterns used to extract a template or other identifier or identifying information. such as, fingerprints, faceprints, and voiceprints, iris or retina scans, keystroke, gait, or other physical patters, and sleep, health, or exercise data.

NO

F. Internet or other similar network activity.

Browsing history, search history, information in a consumer's intraction with a website, application, or advertisement.

YES

G. Geolocation data.

Physical location or movements

YES

H. Sensory data

Audio, electronic, visual, thermal, olfactory, or similar information.

NO

I. Professional or employment-ralated information.

Current or post job history or perfomance evaluations.

YES

J. Non-public education information (per the family Education Rights and Privacy Act (20 U.S.C Section 1232g, 34 C.F.R Part99)).

Education records directly related to a student maintained by an education institution or party acting on its behalf, such as graded, transcripts, class lists, student schedules, student identification code, student financial indormation, or student dosciplinary records.

YES

K. Inferences drawn from other personal information.

Profile reflecting a person's preferences, characteristics, phychological treds, predispositons, behavior, attitudes, intelligence, abilities, and aptitudes.

YES

Personal information does not include:

  • Publicly available information from government records.
  • Deidentified or aggregated consumer information.
  • Information excluded from the CCPA’s scope, like:
  • health or medical information covered by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the California Confidentiality of Medical Information Act (CMIA) or clinical trial data;
  • personal information covered by certain sector-specific privacy laws, including the Fair Credit Reporting Act (FRCA), the Gramm-Leach-Bliley Act (GLBA) or California Financial Information Privacy Act (FIPA), and the Driver’s Privacy Protection Act of 1994.

We obtain the categories of personal information listed above from the following categories of sources:

  • Directly from you. For example, from forms you complete, applications your submit and documentation and information you provide.
  • Indirectly from you. For example, from observing your actions on our Website.
  • From third parties, for example, our business partners.
Use of Personal Information

We may use or disclose the personal information we collect for one or more of the following purposes: 

  • To fulfill or meet the reason you provided the information. For example, if you share your name and contact information to in connection with an application for one of our income sharing programs or ask a question about such programs or related products, we will use that personal information to respond to your inquiry. If you provide your personal information to subscribe to a service, we will use that information to process your request and facilitate delivery. We may also save your information to facilitate new transactions. 
  • To provide, support, personalize, and develop our Website, products, and services.
  • To create, maintain, customize, and secure your account with us.
  • To process your requests, transactions and payments and prevent transactional fraud.
  • To provide you with support and to respond to your inquiries, including to investigate and address your concerns and monitor and improve our responses.
  • To personalize your Website experience and to deliver content and product and service offerings relevant to your interests, including targeted offers and ads through our Website, third-party sites, and via email or text message (with your consent).
  • To help maintain the safety, security, and integrity of our Website, products and services, databases and other technology assets, and business.
  • For testing, research, analysis, and product development, including to develop and improve our Website, products, and services.
  • To respond to law enforcement requests and as required by applicable law, court order, or governmental regulations.
  • As described to you when collecting your personal information or as otherwise set forth in the CCPA.
  • To evaluate or conduct a merger, divestiture, restructuring, reorganization, dissolution, or other sale or transfer of some or all of our assets, whether as a going concern or as part of bankruptcy, liquidation, or similar proceeding, in which personal information held by us about our users is among the assets transferred.

We will not collect additional categories of personal information or use the personal information we collected for materially different, unrelated, or incompatible purposes without providing you notice.

Sharing Personal Information

We may disclose your personal information to a third party for a business purpose.  When we disclose personal information for a business purpose, we enter a contract that describes the purpose and requires the recipient to both keep that personal information confidential and not use it for any purpose except performing the contract. 

We share your personal information with the following categories of third parties: 

  • Service providers.
  • Affiliates.
  • Partners.
  • Data aggregators.
  • Parent or subsidiary organizations.
  • Internet cookie data recipients, like Google Analytics.
  • Other third party categories (with your consent).
Disclosures of Personal Information for a Business Purpose

In the preceding twelve (12) months, Company has disclosed the following categories of personal information for a business purpose: 

Category A: Identifiers.
Category B: California Customer Records personal information categories.
Category C: Protected classification characteristics under California or federal law.
Category D: Commercial information.
Category F: Internet or other similar network activity.
Category G: Geolocation data.
Category I: Professional or employment-related information.
Category J: Non-public education information.
Category K: Inferences drawn from other personal information.

We disclose your personal information for a business purpose to the following categories of third parties: 

  • Service providers.
  • Affiliates.
  • Partners.
  • Data aggregators. 
  • Parent or subsidiary organizations.
  • Internet cookie data recipients, like Google Analytics.
  • Other third party categories (with your consent).
Sales of Personal Information 

In the preceding twelve (12) months, Company has not sold personal information. 

Your Rights and Choices 

The CCPA provides consumers (California residents) with specific rights regarding their personal information. This section describes your CCPA rights and explains how to exercise those rights.

Access to Specific Information and Data Portability Rights

You have the right to request that we disclose certain information to you about our collection and use of your personal information over the past 12 months. Once we receive and confirm your verifiable consumer request (see “Exercising Access, Data Portability, and Deletion Rights,” below), we will disclose to you:

  • The categories of personal information we collected about you.
  • The categories of sources for the personal information we collected about you.
  • Our business or commercial purpose for collecting or selling that personal information.
  • The categories of third parties with whom we share that personal information.
  • The specific pieces of personal information we collected about you (also called a data portability request).
  • If we sold or disclosed your personal information for a business purpose, two separate lists disclosing:
  • sales, identifying the personal information categories that each category of recipient purchased; and 
  • disclosures for a business purpose, identifying the personal information categories that each category of recipient obtained. 
Deletion Request Rights 

You have the right to request that we delete any of your personal information that we collected from you and retained, subject to certain exceptions. Once we receive and confirm your verifiable consumer request (see “Exercising Access, Data Portability, and Deletion,” below), we will delete (and direct our service providers to delete) your personal information from our records, unless an exception applies. 

We may deny your deletion request if retaining the information is necessary for us or our service provider(s) to: 

  • Complete the transaction for which we collected the personal information, provide a good or service that you requested, take actions reasonably anticipated within the context of our ongoing business relationship with you, or otherwise perform our contract with you.
  • Detect security incidents, protect against malicious, deceptive, fraudulent, or illegal activity, or prosecute those responsible for such activities.
  • Debug products to identify and repair errors that impair existing intended functionality.
  • Exercise free speech, ensure the right of another consumer to exercise their free speech rights, or exercise another right provided for by law.
  • Comply with the California Electronic Communications Privacy Act (Cal. Penal Code § 1546 et. seq.).
  • Engage in public or peer-reviewed scientific, historical, or statistical research in the public interest that adheres to all other applicable ethics and privacy laws, when the information’s deletion may likely render impossible or seriously impair the research’s achievement, if you previously provided informed consent.
  • Enable solely internal uses that are reasonably aligned with consumer expectations based on your relationship with us.
  • Comply with a legal obligation.
  • Make other internal and lawful uses of that information that are compatible with the context in which you provided it.
Exercising Access, Data Portability, and Deletion Rights

To exercise the access, data portability, and deletion rights described above, please submit a verifiable consumer request to us by contacting us at the addresses below.

Only you, or someone legally authorized to act on your behalf, may make a verifiable consumer request related to your personal information. You may also make a verifiable consumer request on behalf of your minor child. 

You may only make a verifiable consumer request for access or data portability twice within a 12-month period. The verifiable consumer request must:

  • Provide sufficient information that allows us to reasonably verify you are the person about whom we collected personal information or an authorized representative.
  • Describe your request with sufficient detail that allows us to properly understand, evaluate, and respond to it.

We cannot respond to your request or provide you with personal information if we cannot verify your identity or authority to make the request and confirm the personal information relates to you

Making a verifiable consumer request does not require you to create an account with us. However, we do consider requests made through your password protected account sufficiently verified when the request relates to personal information associated with that specific account.

We will only use personal information provided in a verifiable consumer request to verify the requestor’s identity or authority to make the request. 

For instructions on exercising sale opt-out rights, see Personal Information Sales Opt-Out and Opt-In Rights.

Response Timing and Format

We endeavor to respond to a verifiable consumer request within forty-five (45) days of its receipt. If we require more time (up to 90 days), we will inform you of the reason and extension period in writing.

If you have an account with us, we will deliver our written response to that account. If you do not have an account with us, we will deliver our written response by mail or electronically, at your option. 

Any disclosures we provide will only cover the 12-month period preceding the verifiable consumer request’s receipt. The response we provide will also explain the reasons we cannot comply with a request, if applicable. For data portability requests, we will select a format to provide your personal information that is readily useable and should allow you to transmit the information from one entity to another entity without hindrance.

We do not charge a fee to process or respond to your verifiable consumer request unless it is excessive, repetitive, or manifestly unfounded. If we determine that the request warrants a fee, we will tell you why we made that decision and provide you with a cost estimate before completing your request. 

Non-Discrimination

We will not discriminate against you for exercising any of your CCPA rights. Unless permitted by the CCPA, we will not:

  • Deny you goods or services.
  • Charge you different prices or rates for goods or services, including through granting discounts or other benefits, or imposing penalties.
  • Provide you a different level or quality of goods or services.
  • Suggest that you may receive a different price or rate for goods or services or a different level or quality of goods or services.

However, we may offer you certain financial incentives permitted by the CCPA that can result in different prices, rates, or quality levels. Any CCPA-permitted financial incentive we offer will reasonably relate to your personal information’s value and contain written terms that describe the program’s material aspects. Participation in a financial incentive program requires your prior opt in consent, which you may revoke at any time. 

Other California Privacy Rights
California’s “Shine the Light” law (Civil Code § 1798.83) permits users of our Website that are California residents to request certain information regarding our disclosure of personal information to third parties for their direct marketing purposes. To make such a request, please send an email to the address identified below.

Changes to this Privacy Policy

Access Bio reserves the right to change this Privacy Policy from time to time. When changes are made, an updated Privacy Policy will be posted on our Site. We will notify you about changes to this Privacy Policy by sending a notice to the primary email address specified in your account, by placing a prominent notice on our Site. The date the Privacy Policy was last revised is identified at the bottom of this page. Your continued use of the Site and/or Services available through this Site after such modifications will constitute your: (a) acknowledgment of the modified Privacy Policy; and (b) agreement to abide and be bound by that Policy.

Your Choices

You can review and change your personal information by contacting us to request access to correct or delete any personal information that you have provided to us. We may not accommodate a request to change information if we believe the change would violate any law or legal requirement or cause the information to be incorrect.

Contact Information

Access Bio welcomes your questions, comments, and concerns regarding this Privacy Policy. If you believe that Access Bio has not adhered to this Privacy Policy, please contact Access Bio at:

Access Bio, Inc.
65 Clyde Rd. Suite A Somerset,
NJ 08873 USA
Tel. 732 873 4040
Email. info@accessbio.net

Effective as of August 27, 2020

No representations or claims regarding Access Bio products are intended to substitute for professional medical advice. Access Bio recommends that you always seek the advice of a qualified healthcare provider with any questions you may have regarding a medical question or condition.

Terms and Conditions

Terms and Conditions 150 150 axadmin

Terms and Conditions

Agreement between User and accessbio.net

Welcome to accessbio.net. The accessbio.net website (the “Site”) is comprised of various web pages operated by Access Bio, Inc. (“Access Bio”). The Site is offered to you conditioned on your acceptance without modification of the terms, conditions, and notices contained herein (the “Terms”). Our Privacy Policy, found at accessbio.net/privacy-policy/, is part of and hereby incorporated into these Terms. Your use of the Site constitutes your agreement to all such Terms. Please read these terms carefully, and keep a copy of them for your reference. accessbio.net is an E-Commerce Site, for the primary purpose of furthering Access Bio’s mission is to improve the lives and well-being of people around the world. Through the development of in vitro diagnostics technology, Access Bio has successfully commercialized the highest quality products to battle malaria and other serious diseases.

Electronic Communications

Visiting accessbio.net or sending emails to Access Bio constitutes electronic communications. You consent to receive electronic communications and you agree that all agreements, notices, disclosures and other communications that we provide to you electronically, via email and on the Site, satisfy any legal requirement that such communications be in writing.

Children Under Thirteen

Access Bio does not knowingly collect, either online or offline, personal information from persons under the age of thirteen. If you are under 18, you may use accessbio.net only with the permission of a parent or guardian. California residents under 16 years of age may have additional rights regarding the collection and sale of their personal information. Please see the Privacy Policy section regarding California for more information.

Links to Third Party Sites/Third Party Services

accessbio.net may contain links to other websites (“Linked Sites”). The Linked Sites are not under the control of Access Bio and Access Bio is not responsible for the contents of any Linked Site, including without limitation any link contained in a Linked Site, or any changes or updates to a Linked Site. Access Bio is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement by Access Bio of the site or any association with its operators. If you access any Linked Site, you do so entirely at your own risk and subject to the terms and conditions of use for such websites.

Certain services made available via the Site are delivered by third party sites and organizations. By using any product, service or functionality originating from the accessbio.net domain, you hereby acknowledge and consent that Access Bio may share such information and data with any third party with whom Access Bio has a contractual relationship to provide the requested product, service or functionality on behalf of accessbio.net users and customers. Please see our Privacy Policy, found at accessbio.net/privacy-policy/, for more details about how Access Bio may collect, use, and disclose information and data.

No Unlawful or Prohibited Use/Intellectual Property

You are granted a non-exclusive, non-transferable, revocable license to access and use accessbio.net strictly in accordance with these terms of use. As a condition of your use of the Site, you warrant to Access Bio that you will not use the Site for any purpose that is unlawful or prohibited by these Terms. You may not use the Site in any manner which could damage, disable, overburden, or impair the Site or interfere with any other party’s use and enjoyment of the Site. You may not obtain or attempt to obtain any materials or information through any means not intentionally made available or provided for through the Site.

No Unlawful or Prohibited Use/Intellectual Property

You are granted a non-exclusive, non-transferable, revocable license to access and use accessbio.net strictly in accordance with these terms of use. As a condition of your use of the Site, you warrant to Access Bio that you will not use the Site for any purpose that is unlawful or prohibited by these Terms. You may not use the Site in any manner which could damage, disable, overburden, or impair the Site or interfere with any other party’s use and enjoyment of the Site. You may not obtain or attempt to obtain any materials or information through any means not intentionally made available or provided for through the Site.

All content included as part of the Site, such as text, graphics, logos, images, as well as the compilation thereof, and any software used on the Site, is the property of Access Bio or its suppliers and protected by copyright and other laws that protect intellectual property and proprietary rights. You agree to observe and abide by all copyright and other proprietary notices, legends or other restrictions contained in any such content and will not make any changes thereto.

You will not modify, publish, transmit, reverse engineer, participate in the transfer or sale, create derivative works, or in any way exploit any of the content, in whole or in part, found on the Site. Access Bio content is not for resale. Your use of the Site does not entitle you to make any unauthorized use of any protected content, and in particular, you will not delete or alter any proprietary rights or attribution notices in any content. You will use protected content solely for your personal use and will make no other use of the content without the express written permission of Access Bio and the copyright owner. You agree that you do not acquire any ownership rights in any protected content. We do not grant you any licenses, express or implied, to the intellectual property of Access Bio or our licensors except as expressly authorized by these Terms.

Use of Communication Services

The Site may contain bulletin board services, chat areas, news groups, forums, communities, personal web pages, calendars, and/or other message or communication facilities designed to enable you to communicate with the public at large or with a group (collectively, “Communication Services”). You agree to use the Communication Services only to post, send, and receive messages and material that are proper and related to the particular Communication Service.

By way of example, and not as a limitation, you agree that when using a Communication Service, you will not: defame, abuse, harass, stalk, threaten or otherwise violate the legal rights (such as rights of privacy and publicity) of others; publish, post, upload, distribute or disseminate any inappropriate, profane, defamatory, infringing, obscene, indecent or unlawful topic, name, material or information; upload files that contain software or other material protected by intellectual property laws (or by rights of privacy of publicity) unless you own or control the rights thereto or have received all necessary consents; upload files that contain viruses, corrupted files, or any other similar software or programs that may damage the operation of another’s computer; advertise or offer to sell or buy any goods or services for any business purpose, unless such Communication Service specifically allows such messages; conduct or forward surveys, contests, pyramid schemes or chain letters; download any file posted by another user of a Communication Service that you know, or reasonably should know, cannot be legally distributed in such manner; falsify or delete any author attributions, legal or other proper notices or proprietary designations or labels of the origin or source of software or other material contained in a file that is uploaded; restrict or inhibit any other user from using and enjoying the Communication Services; violate any code of conduct or other guidelines which may be applicable for any particular Communication Service; harvest or otherwise collect information about others, including e-mail addresses, without their consent; violate any applicable laws or regulations.

Access Bio has no obligation to monitor the Communication Services. However, Access Bio reserves the right to review materials posted to a Communication Service and to remove any materials in its sole discretion.

Access Bio reserves the right to terminate your access to any or all of the Communication Services at any time without notice for any reason whatsoever. Access Bio reserves the right at all times to disclose any information as necessary to satisfy any applicable law, regulation, legal process or governmental request, or to edit, refuse to post or to remove any information or materials, in whole or in part, in Access Bio’s sole discretion.

Always use caution when giving out any personally identifying information about yourself or your children in any Communication Service. Access Bio does not control or endorse the content, messages or information found in any Communication Service and, therefore, Access Bio specifically disclaims any liability with regard to the Communication Services and any actions resulting from your participation in any Communication Service. Managers and hosts are not authorized Access Bio spokespersons, and their views do not necessarily reflect those of Access Bio.

Materials uploaded to a Communication Service may be subject to posted limitations on usage, reproduction, and/or dissemination. You are responsible for adhering to such limitations if you upload the materials.

Materials Provided to accessbio.net or Posted on Any Access Bio Web Page

Access Bio does not claim ownership of the materials you provide to accessbio.net (including feedback and suggestions) or post, upload, input or submit to any Access Bio Site or our associated services (collectively “Submissions”). However, by posting, uploading, inputting, providing or submitting your Submission you are granting Access Bio, our affiliated companies and necessary sublicensees permission to use your Submission in connection with the operation of their Internet businesses including, without limitation, the rights to copy, distribute, transmit, publicly display, publicly perform, reproduce, edit, translate and reformat your Submission; and to publish your name in connection with your Submission.

No compensation will be paid with respect to the use of your Submission, as provided herein. Access Bio is under no obligation to post or use any Submission you may provide and may remove any Submission at any time in Access Bio’s sole discretion.

By posting, uploading, inputting, providing or submitting your Submission you warrant and represent that you own or otherwise control all of the rights to your Submission as described in this section including, without limitation, all the rights necessary for you to provide, post, upload, input or submit the Submissions.

Third-Party Accounts

You may be able to connect your Access Bio account to third party accounts. By connecting your Access Bio account to your third-party account, you acknowledge and agree that you are consenting to the continuous release of information about you to others (in accordance with your privacy settings on those third-party sites). If you do not want information about you to be shared in this manner, do not use this feature.

International Users

The Service is controlled, operated, and administered by Access Bio from our offices within the USA. If you access the Service from a location outside the USA, you are responsible for compliance with all local laws. You agree that you will not use the Access Bio Content accessed through accessbio.net in any country or in any manner prohibited by any applicable laws, restrictions, or regulations.

Indemnification

You agree to indemnify, defend and hold harmless Access Bio, its officers, directors, employees, agents and third parties, for any losses, costs, liabilities, and expenses (including reasonable attorney’s fees) relating to or arising out of your use of or inability to use the Site or services, any user postings made by you, your violation of any terms of this Agreement or your violation of any rights of a third party, or your violation of any applicable laws, rules or regulations. Access Bio reserves the right, at its own cost, to assume the exclusive defense and control of any matter otherwise subject to indemnification by you, in which event you will fully cooperate with Access Bio in asserting any available defenses.

Arbitration

In the event, the parties are not able to resolve any dispute between them arising out of or concerning these Terms and Conditions, or any provisions hereof, whether in contract, tort, or otherwise at law or in equity for damages or any other relief, then such dispute shall be resolved only by final and binding arbitration pursuant to the Federal Arbitration Act, conducted by a single neutral arbitrator and administered by the American Arbitration Association, or a similar arbitration service selected by the parties, in a location mutually agreed upon by the parties. The arbitrator’s award shall be final, and judgment may be entered upon it in any court having jurisdiction. In the event that any legal or equitable action, proceeding or arbitration arises out of or concerns these Terms and Conditions, the prevailing party shall be entitled to recover its costs and reasonable attorney’s fees. The parties agree to arbitrate all disputes and claims in regards to these Terms and Conditions or any disputes arising as a result of these Terms and Conditions, whether directly or indirectly, including Tort claims that are a result of these Terms and Conditions. The parties agree that the Federal Arbitration Act governs the interpretation and enforcement of this provision. The entire dispute, including the scope and enforceability of this arbitration provision shall be determined by the Arbitrator. This arbitration provision shall survive the termination of these Terms and Conditions

Class Action Waiver

Any arbitration under these Terms and Conditions will take place on an individual basis; class arbitrations and class/representative/collective actions are not permitted. THE PARTIES AGREE THAT A PARTY MAY BRING CLAIMS AGAINST THE OTHER ONLY IN EACH’S INDIVIDUAL CAPACITY, AND NOT AS A PLAINTIFF OR CLASS MEMBER IN MY PUTATIVE CLASS, COLLECTIVE AND/ OR REPRESENTATIVE PROCEEDING, SUCH AS IN THE FORM OF A PRIVATE ATTORNEY GENERAL ACTION AGAINST THE OTHER. Further, unless both you and Access Bio agree otherwise, the arbitrator may not consolidate more than one person’s claims, and may not otherwise preside over any form of a representative or class proceeding.

Liability Disclaimer

THE INFORMATION, SOFTWARE, PRODUCTS, AND SERVICES INCLUDED IN OR AVAILABLE THROUGH THE SITE MAY INCLUDE INACCURACIES OR TYPOGRAPHICAL ERRORS. CHANGES ARE PERIODICALLY ADDED TO THE INFORMATION HEREIN. ACCESS BIO AND/OR ITS SUPPLIERS MAY MAKE IMPROVEMENTS AND/OR CHANGES IN THE SITE AT ANY TIME. ACCESS BIO AND/OR ITS SUPPLIERS MAKE NO REPRESENTATIONS ABOUT THE SUITABILITY, RELIABILITY, AVAILABILITY, TIMELINESS, AND ACCURACY OF THE INFORMATION, SOFTWARE, PRODUCTS, SERVICES AND RELATED GRAPHICS CONTAINED ON THE SITE FOR ANY PURPOSE. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, ALL SUCH INFORMATION, SOFTWARE, PRODUCTS, SERVICES, AND RELATED GRAPHICS ARE PROVIDED “AS IS” WITHOUT WARRANTY OR CONDITION OF ANY KIND.

ACCESS BIO AND/OR ITS SUPPLIERS HEREBY DISCLAIM ALL WARRANTIES AND CONDITIONS WITH REGARD TO THIS INFORMATION, SOFTWARE, PRODUCTS, SERVICES, AND RELATED GRAPHICS, INCLUDING ALL IMPLIED WARRANTIES OR CONDITIONS OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE AND NON-INFRINGEMENT.

TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT SHALL ACCESS BIO AND/OR ITS SUPPLIERS BE LIABLE FOR ANY DIRECT, INDIRECT, PUNITIVE, INCIDENTAL, SPECIAL, CONSEQUENTIAL DAMAGES OR ANY DAMAGES WHATSOEVER INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF USE, DATA OR PROFITS, ARISING OUT OF OR IN ANY WAY CONNECTED WITH THE USE OR PERFORMANCE OF THE SITE, WITH THE DELAY OR INABILITY TO USE THE SITE OR RELATED SERVICES, THE PROVISION OF OR FAILURE TO PROVIDE SERVICES, OR FOR ANY INFORMATION, SOFTWARE, PRODUCTS, SERVICES AND RELATED GRAPHICS OBTAINED THROUGH THE SITE, OR OTHERWISE ARISING OUT OF THE USE OF THE SITE, WHETHER BASED ON CONTRACT, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE, EVEN IF ACCESS BIO OR ANY OF ITS SUPPLIERS HAS BEEN ADVISED OF THE POSSIBILITY OF DAMAGES. BECAUSE SOME STATES/JURISDICTIONS DO NOT ALLOW THE EXCLUSION OR LIMITATION OF LIABILITY FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES, THE ABOVE LIMITATION MAY NOT APPLY TO YOU. IF YOU ARE DISSATISFIED WITH ANY PORTION OF THE SITE, OR WITH ANY OF THESE TERMS OF USE, YOUR SOLE AND EXCLUSIVE REMEDY IS TO DISCONTINUE USING THE SITE.

Termination/Access Restriction

Access Bio reserves the right in its sole discretion to terminate your access to the Site and the related services or any portion thereof at any time, without notice.

Governing Law/Entire Agreement

To the maximum extent permitted by law, this agreement is governed by the laws of the State of California and you hereby consent to the exclusive jurisdiction and venue of courts in California in all disputes arising out of or relating to the use of the Site. Use of the Site is unauthorized in any jurisdiction that does not give effect to all provisions of these Terms, including, without limitation, this section.

You agree that no joint venture, partnership, employment, or agency relationship exists between you and Access Bio as a result of this agreement or use of the Site. Access Bio’s performance of this agreement is subject to existing laws and legal process, and nothing contained in this agreement is in derogation of Access Bio’s right to comply with governmental, court and law enforcement requests or requirements relating to your use of the Site or information provided to or gathered by Access Bio with respect to such use. If any part of this agreement is determined to be invalid or unenforceable pursuant to applicable law including, but not limited to, the warranty disclaimers and liability limitations set forth above, then the invalid or unenforceable provision will be deemed superseded by a valid, enforceable provision that most closely matches the intent of the original provision and the remainder of the agreement shall continue in effect. Unless otherwise specified herein, this agreement constitutes the entire agreement between the user and Access Bio with respect to the Site and it supersedes all prior or contemporaneous communications and proposals, whether electronic, oral or written, between the user and Access Bio with respect to the Site. A printed version of this agreement and of any notice given in electronic form shall be admissible in judicial or administrative proceedings based upon or relating to this agreement to the same extent and subject to the same conditions as other business documents and records originally generated and maintained in printed form. It is the express wish to the parties that this agreement and all related documents be written in English.

Changes to Terms

Access Bio reserves the right, in its sole discretion, to change the Terms under which the Site is offered. When changes are made, Access Bio will make a new copy of the Terms available on the Site. The most current version of the Terms will supersede all previous versions, is effective immediately upon posting to the Site, and will apply to all access and use of the Site from that point onward. The date the Terms were last revised is identified at the bottom of this page. Access Bio encourages you to periodically review the Terms to stay informed of our updates.

Contact Us

Access Bio welcomes your questions or comments regarding the Terms:

Access Bio, Inc.
65 Clyde Rd. Suite A Somerset,
NJ 08873 USA
Tel. 732 873 4040
Email. info@accessbio.net
Effective as of August 27, 2020

No representations or claims regarding Access Bio products are intended to substitute for professional medical advice. Access Bio recommends that you always seek the advice of a qualified healthcare provider with any questions you may have regarding a medical question or condition.

IN PARTNERSHIP WITH THE GLOBAL GOOD

IN PARTNERSHIP WITH THE GLOBAL GOOD 150 150 axadmin

Access Bio and Global Good Release Ultra-Sensitive P. falciparum Malaria Detection Kit That Displays Up to Five-Fold Im

New rapid diagnostic test now available to research organizations for low parasitemia settings

Bellevue, WA
December 18, 2019

AccessBio (KOSDAQ: 950130) and collaboration partner Global Good have developed a new ultra-sensitive rapid diagnostic test (uRDT) that is five times more analytically sensitive in identifying histidine-rich protein 2 (HRP2) antigens than currently available uRDTs.

“With decades of experience optimizing lateral flow assays, we have carefully designed the system together with Global Good to increase sensitivity without significantly increasing the complexity or cost of the assay,” said Young Ho Choi, Founder and CEO of AccessBio. “And now the assay is available for use by malaria elimination research organizations and antenatal screening clinics where low parasitemia counts complicate detection.”

“Our team confirmed a reproduceable and consistent five-fold improvement in detection limits with more than 95% specificity through trials conducted at the IV Laboratory,” said Kevin Nichols, Principal Investigator for Flow-based Diagnostics at the Intellectual Ventures Laboratory.

“AccessBio has now incorporated this capability into a new uRDT research product that could complement P. falciparum elimination efforts where a downward trend of falciparum cases has been observed. Tests that can detect very low levels of malaria intensity at the point of care are essential to reach the malaria elimination milestones of the WHO Global Technical Strategy for Malaria 2016-2030,” said Nichols.

“As highlighted in the recently released 2019 World Malaria Report, pregnant women and children continue to be the most vulnerable populations to malaria. And with most pregnant mothers typically attending at least one routine pre-birth visit to a clinic, antenatal settings may also present an opportune moment for future uRDT research trials to screen for malaria,” said Nichols.

Read more about AccessBio and Global Good’s collaborative work on HRP2-deleted detection kits here.

About Global Good

Millions of people suffer and die each year in poor countries from causes that humanity has the scientific and technical ability to solve. Funded by Bill Gates and focused on a shared vision with Nathan Myhrvold, Global Good invents technology to solve some of humanity’s most daunting problems. We do this by collaborating with leading humanitarian organizations, forward-looking governments, research institutions, and corporate and private sector partners that bring our inventions to market. www.globalgood.com.

About Access Bio

Headquartered in Somerset, New Jersey, Access Bio is a manufacturer of in vitro diagnostic tests with the manufacturing facilities in the U.S., Ethiopia, and South Korea. The company (KOSDAQ: 950130) is dedicated to the prevention and early diagnosis of infectious diseases. Access Bio has a comprehensive line of diagnostic platforms, including rapid immunoassays, biosensors, and molecular tests. Of note, the company is the leading global supplier of malaria rapid tests, annually making more than 130 million tests. In the global health arena, Access Bio’s mission is to make high-quality diagnostic tests accessible and affordable for its customers, particularly the ones in low- and middle-income countries (LMICs), through its expertise in innovative manufacturing. www.accessbio.net

Access Bio’s US-made rapid serology test just granted EUA by the FDA

Access Bio’s US-made rapid serology test just granted EUA by the FDA 150 150 axadmin

Access Bio Granted Emergency Use Authorization by FDA for CareStart™ COVID-19 IgM/IgG Antibody Test

Global Leader in Infectious Disease Diagnosis Receives FDA EUA for Serology Test Capable of Determining Subjects’ past COVID-19 Exposure and Immunoresponse within 10 Minutes

July 24th, 2020 (SOMERSET, NJ)Access Bio, Inc., a longstanding leader in the development of diagnostic tests for infectious diseases through research, development and manufacturing, today announced that the U.S. Food and Drug Administration (FDA), has granted the company Emergency Use Authorization (EUA) for its CareStart™ COVID-19 IgM/IgG antibody test. This lateral flow antibody test represents the first of its kind to be truly 100% manufactured in the U.S.A..

Manufactured entirely in the United States, the CareStart™ COVID-19 IgM/IgG test is a rapid SARS CoV-2 lateral flow immunochromatographic assay, designed to indicate past exposure to, and infection by the novel coronavirus (SARS-CoV-2). Access Bio’s serology test detects and differentiates IgM and IgG antibodies in human blood specimens with combined 100% sensitivity and 97.5% specificity. Healthcare providers administering the test only require a small sample volume (10 uL) of whole blood via a finger lancet and may be used with serum or plasma as well. Results are then determined within a 10 minute window.

Additionally, the CareStart™ COVID-19 IgM/IgG from Access Bio was tested in an independent clinical study Jun 2, 2020 at the Frederick National Laboratory for Cancer Research (FNLCR) sponsored by the National Cancer Institute (NCI) and was found to have 100% sensitivity and 97.5% specificity.

“COVID-19’s rapid spread throughout the United States was unprecedented and left our country reeling, and lacking adequate testing and tracing solutions,” said Young H. Choi, President and CEO, Access Bio. “Our serology test’s performance and quality will help scale mass determination of COVID-19 exposure while offering an unrivaled new tool for helping trace and curb the pandemic’s spread.”

The CareStart™ COVID-19  IgM/IgG test is the second COVID-19 test kit from Access Bio to receive EUA authorization from the FDA after its CareStart™ MDx RT-PCR test. Both tests will be distributed in partnership with Intrivo Diagnostics, which will act as a resource for qualified healthcare professionals.

“The availability of the CareStart™ COVID-19 IgM/IgG test kit brings needed Covid-19 antibody diagnostic testing to millions of patients across the U.S. and world during the current pandemic,” said Michael Harbour, MD, MPH, Chief Medical Officer, Intrivo Diagnostics. “These high-quality tests are manufactured in the U.S. by Access Bio, a company with a long history of engineering and manufacturing superior quality diagnostic kits for malaria, dengue, typhus and other infectious diseases.”

Established in 2002, Access Bio has a proven track record of releasing top-performing products, including its CareStart™ Malaria Rapid Diagnostic Test (RDT).  Access Bio’s molecular technologies help diagnose infection and disorders using genetic information, such as DNA and RNA to obtain more accurate diagnoses compared to conventional immunological or biochemical diagnostic products.

Access Bio distributes its products to more than 120 countries around the world, thanks to scalable infrastructure consisting of R&D and production facilities in the United States, South Korea and Ethiopia. Access Bio is traded on the Korean Stock Exchange (KRX) under the stock symbol, KR: 950130.

For more information about Access Bio and the CareStart™ COVID-19 IgM/IgG test, please visit: www.carestart.com.

About Access Bio: Access Bio was founded by Young Ho Choi in 2002 in Somerset, New Jersey and quickly established itself as a long-standing global leader in diagnostic testing, striving to create a foundation of well-being for all people.With a history of creating revolutionary products, such as the CareStart™ Malaria Rapid Detection Test, Access Bio remains a leader in accurate, sustainable and cost-effect diagnosis solutions.

About Intrivo Diagnostics: Headquartered in Los Angeles, CA, Intrivo Diagnostics is an organization driven by science and dedicated to providing accurate and easy-to-use diagnostic testing to save lives and slow the spread of infectious diseases.  Intrivo Diagnostics’ mission is to distribute exceptional products to address the urgent demand for high-quality diagnostic testing. In keeping with that mission, Intrivo Diagnostic is the exclusive distribution partner for Access Bio, Inc.’s CareStart™ line of COVID-19 testing products, all of which are solely manufactured in the USA.

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Access Bio Granted Emergency Use Authorization by FDA for CareStart™ COVID-19 MDx RT-PCR Test

Global Leader in Infectious Disease Diagnosis Receives FDA EUA for Molecular Test that May Provide Laboratories Results in 83 Minutes or Less

July 21, 2020 (SOMERSET, NJ)Access Bio, Inc., a long-standing leader in the development of diagnostic tests for infectious diseases through research, development and manufacturing, today announced that the U.S. Food and Drug Administration (FDA) has granted the company Emergency Use Authorization (EUA) for its SARS CoV-2 RT-PCR test.

Manufactured entirely in the United States, the CareStart™ COVID-19 MDx RT-PCR test uses real-time reverse transcription-polymerase chain reaction (RT-PCR) to detect RNA of the COVID-19 nucleocapsid gene (N gene) and RNA-dependent RNA polymerase gene (RdRp gene) in test subjects, resulting in faster results (83 minutes), as well as 100% sensitivity and 100% specificity.

Access Bio has confirmed 100% consistency in positive (PPA) and negative (NPA) groups during clinical evaluations from samples collected by nasopharyngeal swab from symptomatic patients during the 2020 COVID-19 pandemic period. The CareStart™ COVID-19 MDx RT-PCR test is authorized for distribution and use by healthcare professionals and health systems conducting COVID-19 testing. Specimens are then delivered for analysis to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) who are subject to reporting test results to healthcare providers and relevant public health authorities as appropriate. Analysis does not require a proprietary system and can be run on some of the most common PCR processing solutions, such as Bio-Rad’s CFX96 Dx system and Thermo Fisher Scientific’s Applied Biosystems 7500 or 7500 Fast RT-PCR instrument. Additional information surrounding instructions for use with each system can be found at https://carestart.com/.

“The novel coronavirus is showing no sign of slowing in the United States or other parts of the world, making the ability to quickly scale testing and diagnosis a priority,” said Young H. Choi, President and CEO, Access Bio. “Our products are manufactured wholly in the United States and are used by the world’s largest global health and humanitarian response organizations. We’ve worked to ensure the CareStart’s accuracy and reliability will make it a leading diagnostic testing solution in a market plagued by false methodologies and subpar alternatives.”

The CareStart™ COVID-19 MDx RT-PCR test is designed for use on SARS-CoV-2 nucleic acid that has been extracted, isolated and purified from nasopharyngeal or oropharyngeal swab specimens. The purified nucleic acid is then reverse transcribed into cDNA followed by PCR amplification and detection using an authorized realtime (RT) PCR instrument. The CareStart™ COVID-19 MDx RT-PCR test includes: 4×1 Step RT-PCR Mix, SARS-CoV-2 primer/probe Mix, MS2 Phage Control, External Positive Control, and External Negative Control.

Access Bio’s CareStart™ RT-PCR test is the first in the company’s CareStart line to be granted Emergency Use Authorization by the FDA, with an IgM/IgG antibody kit also currently under evaluation for FDA EUA. Upon receiving validation, the CareStart™ COVID-19 IgM/IgG Rapid Diagnostic Test will be distributed in partnership with Intrivo Diagnostics, which will act as a resource for qualified buyers — providers & healthcare professionals, payers and patients — to purchase the point-of-care antibody kits.

“The availability of the CareStart™ COVID-19 MDx RT-PCR brings needed Covid-19 viral diagnostic testing to millions of patients across the U.S. and world during the current pandemic,” said Michael Harbour, MD, MPH, Chief Medical Officer, Intrivo Diagnostics. “These high-quality tests are manufactured in the U.S. by Access Bio, a company with a long history of engineering and manufacturing superior quality diagnostic kits for malaria, dengue, typhus and other infectious diseases.”

Established in 2002, Access Bio has a proven track record of releasing top-performing products, including its CareStart™ Malaria Rapid Diagnostic Test (RDT), which is global leader in malaria testing market, supplying more that 100 million malaria tests per year. The product’s success garnered the New Jersey-based manufacturer recognition from the World Health Organization (WHO) and earned numerous accolades and research grants. Access Bio went on to land R&D partnerships with the several US GOV organizations.

Access Bio distributes its products to more than 120 countries around the world, thanks to scalable infrastructure consisting of R&D and production facilities in the United States, South Korea and Ethiopia. Access Bio is traded on the Korean Stock Exchange (KRX) under the stock symbol, KR: 950130.

For more information about Access Bio and the CareStart™ COVID-19 MDx RT-PCR test, please visit: https://www.carestart.com.

About Access Bio:

Access Bio was founded by Young Ho Choi in 2002 and quickly established itself as a long-standing global leader in diagnostic testing, striving to create a foundation of well-being for all people. Access Bio’s molecular technologies diagnose infection and disorders using genetic information, such as DNA and RNA to obtain more accurate diagnoses compared to conventional immunological or biochemical diagnostic products. With a history of creating revolutionary products, such as the CareStart™ Malaria Rapid Detection Test, Access Bio remains a leader in accurate, sustainable and cost-effect diagnosis solutions.

About Intrivo Diagnostics:

Headquartered in Los Angeles, CA, Intrivo Diagnostics is an organization driven by science and dedicated to providing sophisticated and accurate diagnostic testing to save lives and slow the spread of infectious diseases.  Intrivo Diagnostics’ mission is to distribute exceptional products to address the urgent demand for high-quality diagnostic testing. In keeping with that mission, Intrivo Diagnostic is the exclusive distribution partner for Access Bio, Inc.’s CareStart™ line of COVID-19 testing products, all of which are solely manufactured in the USA.

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