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.

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.