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

December 17, 2020 --

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 test, IgM/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/

Concordance Healthcare Solutions and NDC INK National Distribution Agreements

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

December 03, 2020 -- 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 CareStart^TM 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 test, IgM/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 CareStart^TM 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 CareStart^TM 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 CareStart^TM 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^TM COVID-19 line of products, please visit: https://accessbiodiagnostics.net/

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

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.

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 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://carestart.com/

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: 4x1 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.

Getting Tests Where They’re Needed Most

Access Bio was founded on the basic principle of cherishing life and health for all people. The company has emerged as a leader in the diagnosis of infectious diseases. Although it provides a comprehensive portfolio, Access Bio is known for its work against malaria, HIV, HPV, and now, COVID-19.

Core to fulfilling this mission is Access Bio’s unique structure that allows them to be both nimble and responsive to emerging threats and trends but gives them the size, strength, and reach necessary to distribute fairly-priced products all over the world. Access Bio is headquartered in the United States, with production facilities strategically located in New Jersey, Ethiopia, and South Korea. Access Bio can produce more than 170 million rapid diagnostic tests a year, and distributes products to more than 120 different countries.

At the beginning of COVID-19 pandemic, Access Bio mobilized to produce the high-quality, highly sensitive tests required to help stop the spread. It has developed PCR, antigen, and antibody testing, to better assess not only active infections but past exposure to SARS-CoV-2. Access Bio quickly received approval to distribute the products throughout Asia, and, in March 2020, Access Bio’s PCR test was CE-marked. On July 21, 2020, the company announced that its CareStart™ COVID-19 MDx RT-PCR test was granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration.

The announcement comes at a critical time: the nation lost valuable time in developing effective testing options and had been burdened by sub-standard or defective tests. Access Bio has long been a trusted partner to organizations that include UNICEF and the World Health Organization. Together with the fact that the company can domestically produce more than 1.2 million tests a day, there is reason for hope that the nation may be able to test at the volume necessary to aid containment efforts.

The Goal: Ending Malaria in Our Lifetime

Malaria and its effects are primarily concentrated in poor, developing nations. in 2018, there were an estimated 228 million cases around the world and more than 400,000 deaths. Of those, more than 90% of cases and mortalities occurred in the sub-Saharan region of Africa, and children under the age of 5 account for two-thirds of all malaria deaths worldwide. This is a disease that robs nations not only of lives but hope for a better future.

The good news is that we have the tools to fight this deadly disease, and experts agree that if these concentrated efforts are sustained, we can eradicate malaria by 2050. The impressive efforts are coordinated by a series of public/private and non-profit partnerships, including organizations such as UNICEF, the World Health Organization, the Bill and Melinda Gates Foundation, GE, and the Global Good Fund, among many others.

Wide-spread testing and surveillance are critical components in the fight against malaria. Over the years, testing has advanced significantly, and today’s tests are characterized by their:

• Reliability: test results must be clear and dependable
• Sensitivity: to provide a clearer and earlier look at potential exposure
• Scale: tests must be not only available but available at affordable prices
• Ease-of-use: It is crucial that malaria testing can be administered quickly and easily in the field

Access Bio has developed and commercialized a range of malaria testing products, including both RDT and serology tests, allowing health officials to determine if a population has recently been exposed to the malaria parasite, which, in turn, enables the rapid actions necessary to quell or even prevent outbreaks.

The global company, with headquarters in the United States, has received significant grants from the Bill and Melinda Gates Foundation and the Global Good Fund to continue its innovative work – not only in the development of high-quality testing tools, but in producing them at the necessary scale.

“With our commercialization experience and mass production facilities, Access Bio will be able to fully accommodate the commercialization of the highly sensitive RDTs at affordable prices. These tests will be the next generation of diagnostic testing and a big step towards the eradication of malaria,” said Young Ho Choi, Chief Executive Officer of Access Bio.

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.

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 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://carestart.com/

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: 4x1 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.

Getting Tests Where They’re Needed Most

Access Bio was founded on the basic principle of cherishing life and health for all people. The company has emerged as a leader in the diagnosis of infectious diseases. Although it provides a comprehensive portfolio, Access Bio is known for its work against malaria, HIV, HPV, and now, COVID-19.

Core to fulfilling this mission is Access Bio’s unique structure that allows them to be both nimble and responsive to emerging threats and trends but gives them the size, strength, and reach necessary to distribute fairly-priced products all over the world. Access Bio is headquartered in the United States, with production facilities strategically located in New Jersey, Ethiopia, and South Korea. Access Bio can produce more than 170 million rapid diagnostic tests a year, and distributes products to more than 120 different countries.

At the beginning of COVID-19 pandemic, Access Bio mobilized to produce the high-quality, highly sensitive tests required to help stop the spread. It has developed PCR, antigen, and antibody testing, to better assess not only active infections but past exposure to SARS-CoV-2. Access Bio quickly received approval to distribute the products throughout Asia, and, in March 2020, Access Bio’s PCR test was CE-marked. On July 21, 2020, the company announced that its CareStart™ COVID-19 MDx RT-PCR test was granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration.

The announcement comes at a critical time: the nation lost valuable time in developing effective testing options and had been burdened by sub-standard or defective tests. Access Bio has long been a trusted partner to organizations that include UNICEF and the World Health Organization. Together with the fact that the company can domestically produce more than 1.2 million tests a day, there is reason for hope that the nation may be able to test at the volume necessary to aid containment efforts.