We’re here to assist with selection, ordering, and more.
Before we make any diagnostics solutions available, we rigorously test every product to ensure it’s of the highest quality and meets our standards.
We search the world for solutions to the most challenging health problems. We also work with manufacturers to bring their products to market.
Intrivo is a distribution partner you can trust to deliver what you need at the right place and at the right time.
We use advanced supply chain planning tools to maximize value, speed, and cost efficiencies while protecting product integrity.
Clients receive dedicated support and account management to handle inquiries about products, orders, and service needs. We are committed to your satisfaction.
We are proud to be the exclusive distributor for Access Bio’s industry-standard Covid-19 polymerase chain reaction (PCR test), enabling the rapid, accurate identification of those exposed to SARS-CoV-2.
For nearly 20 years, Access Bio has been a global leader in diagnostic testing for infectious diseases. The CareStart™ COVID-19 MDx RT-PCR has been independently tested with results objectively verified: in addition to a CE mark, the test has been authorized by the FDA under an Emergency Use Authorization (EUA).
FDA Emergency Use Authorization
COVID-19 has been designated as a pandemic by the World Health Organization (WHO) and has been detected worldwide. SARS-CoV-2 is highly contagious and has a severe impact on healthcare systems and economy, and rapid testing is a key component to helping to mitigate the spread. The CareStart™ COVID-19 IgM/IgG test provides a fast and easy diagnostic tool for COVID-19 in the limited testing environment.
FDA Emergency Use Authorization
The Access Bio, Inc. CareStart™ 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 swab specimens directly collected from symptomatic individuals who are suspected of COVID-19 by their healthcare provider.
As an intended point-of-care (POC) designated test performed by medical professionals with a 10 minutes processing time, CareStart™ COVID-19 Antigen Test helps provide critical answers about active infections to patients and healthcare workers alike.
FDA Emergency Use Authorization
We provide physicians, providers, and health care systems with diagnostics solutions that help you treat individuals with compassion and certainty, safeguard your community, and enhance the bottom line.
Our goal is to be your partner in public health. With an advisory board that includes physicians who have served the CDC, WHO, and NIC, we ensure alignment between our offerings and large public health initiatives.
Intrivo’s high-quality test offerings deliver the most accurate results, which increases credibility for health care systems and helps payers achieve greater care efficiency and address health needs at the population level.
Dr. Brosgart’s medical career includes senior positions in public health, clinical medicine, clinical research, and drug development; and extensive publishing on infectious diseases. Her professional accomplishments include:
See recent news coverage and releases to learn more about our impact and upcoming products, services, and partnerships.
Agreement expands Intrivo’s list of authorized distributors
Read MoreMajor supply chain agreements will ensure broad access to rapid testing solutions for patients and healthcare providers across US
Read MoreEmergency Use Authorization Granted for CareStartTM Point-Of-Care Kit.
Read MoreGlobal Leader in Infectious Disease Diagnosis Receives FDA EUA for Serology Test.
Read MoreThe Access Bio CareStart™ COVID-19 MDX RT-PCR test is now available for use in the United States.
Read MoreWidescale access to rapid testing is a key part of the strategy to mitigate the spread of COVID-19.
Read MoreWe are the exclusive U.S. distributor oF Access Bio’s COVID-19 PCR test, which was just granted Emergency Authorization Use by the FDA.
Read MoreWe are always seeking to collaborate with forward-thinking individuals, organizations, manufacturers, and institutions.
©2021 Intrivo. All rights reserved.
LOS ANGELES, Dec. 17, 2020 (GLOBE NEWSWIRE) -- 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/
LOS ANGELES, Dec. 03, 2020 (GLOBE NEWSWIRE) -- 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 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 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, please visit: https://intrivo.com/
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 CareStart™ 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 CareStart™ 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 CareStart™ COVID-19 RT-PCR test and CareStart™ 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 CareStart™ 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 CareStart™ COVID-19 Antigen test, please visit: https://www.carestartantigen.com.
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 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 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 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.”
Each CareStart™ 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 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. 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 https://carestart.com/
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 100million 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.
In March 2020, the World Health Organization declared COVID-19 (the disease caused by SARS-CoV-2 or the novel coronavirus) a pandemic. All of the leading global public health organizations agree that large-scale testing is essential to controlling the spread. Even after the development of a vaccine, we will still need to be able to test at high volumes to protect the public health.
Because COVID-19 spread so rapidly in such a short time, many nations were not adequately prepared and were challenged to develop effective testing. In the United States, this shortage was exacerbated by a lack of oversite at the federal level: out of desperation to get tests out into the environment, the FDA allowed many unvetted, poor quality, or defective tests to flood the market. It is unknown how many of these tests have been used, but it is likely that they have contributed to the difficulty in getting the pandemic under control in the United States.
Part of the answer lies with being able to access a variety of high-quality diagnostics tests that allow professionals to test not only for current exposure to the various, but if the person being tested has been exposed to SARS-CoV-2 and has developed antibodies. To help meet this challenge, Intrivo has partnered with global in vitro diagnostics leader Access Bio. With headquarters in New Jersey and a strong state-side supply chain, Access Bio has the capacity to produce more than 1.2 million tests a day.
We are the exclusive U.S. distributor of Access Bio’s COVID-19 PCR test, which was just granted Emergency Authorization Use by the FDA.
In a time of great uncertainty, when even some of the world’s most trusted health institutes lacked a unified understanding of transmission and containment principles of COVID-19, there has never been a greater need for leadership from the scientific community.
Infectious disease experts Dr. Carol Brosgart, MD, and Dr. Michael Harbor, MD, recognized this incredible need when they founded Intrivo Diagnostics. As public health experts, they were frustrated by what they perceived as a piecemeal response to the pandemic, with poor communication between federal and local agencies. And as humanitarians, they felt a true calling to use their resources to make a difference.
Powered by decades of expertise in epidemiology and public health, Intrivo searches out diagnostic solutions for some of the world’s most pressing health challenges. From the very beginning, they understood that the COVID-19 pandemic required a different approach to supplying healthcare systems and public health agencies with testing supplies: one that emphasizes innovation, agility, and responsiveness. This led them to Access Bio, a global health leader in in vitro diagnostics, headquartered in the United States.
Access Bio is most well-known for its work with the Bill and Melinda Gates Foundation to combat malaria, and the company was one of the forerunners in launching COVID-19 testing on a global scale. Access Bio’s PCR test, CareStart™ MDx RT-PCR, received its CE mark in March and just earned Emergency Use Authorization from the FDA. Intrivo is the exclusive U.S. distributor for CareStart™ MDx RT-PCR, available now and shipping immediately.
