NIH collaborates with diagnostics manufacturers on obtaining authorization of multiplex tests

Newswise — To date, nine medical device developers participating in the Rapid Acceleration of Diagnostics (RADx®) Tech Independent Test Assessment Program (ITAP) have received emergency use authorization (EUA) for their devices, facilitating the manufacture of 15 at-home and point-of-care (POC) test products that simultaneously detect COVID-19 and flu A/B. The National Institute of Biomedical Imaging and Bioengineering (NIBIB) at the National Institutes of Health collaborated with the U.S. Food and Drug Administration (FDA) to facilitate this ITAP initiative for the combination tests known as multiplex tests.

RADx Tech programs have supported the development, validation, scale-up, and manufacturing of over-the-counter (OTC, or at-home) and POC tests during the COVID-19 pandemic and beyond. NIBIB issued the OTC multiplex test solicitation in April 2023 with the goal of increasing the availability of multiplex rapid tests for the U.S. market. COVID-19 and flu can have similar symptoms and quickly distinguishing between the viruses is key to effective treatment.

COVID-19 and flu are both contagious respiratory illnesses, but they are caused by different viruses. COVID-19 is caused by infection with SARS-CoV-2 and flu is caused by infection with influenza viruses, including A and B strains. Multiplex tests offer a convenient way for people to know which virus may have been contracted.

“The window for a course of antiviral drug therapy for people with COVID-19 or flu A/B is limited to just days, so prompt diagnosis is critical for the correct treatment to be prescribed,” said Bruce J. Tromberg, Ph.D., director of NIBIB and lead for RADx Tech. “This why it is so important to have multiplex testing available when more than one respiratory virus, with similar symptoms, is circulating in the community.”

ITAP builds on the RADx Tech innovation funnel approach to expedite review and quickly mitigate risks in developing technologies. Seven of the eight OTC tests on the market today were authorized with support from the ITAP program. RADx Tech has also sped the authorization of eight multiplex tests for use at the point-of-care (POC), such as doctors’ offices, clinics, and similar settings.

Authorized OTC Multiplex Tests supported by RADx Tech ITAP

The following OTC lateral flow antigen tests use a self-collected anterior nasal swab from those 14 years or older or adult-collected from children two and older. They are authorized for people with signs and symptoms of respiratory infection consistent with COVID-19 within the first four days of symptom onset when tested at least twice over three days with at least 48 hours between tests.

• Healgen COVID-19/Flu Combo, Healgen®, Houston. Displays result in 15 minutes.
• iHealth COVID-19/Flu A&B Rapid Test, iHealth Labs, Inc., Sunnyvale, California. Displays result in 15 minutes.
• Osom® Flu SARS-CoV-2 Combo Home Test, Sekisui Diagnostics, San Diego. Displays result in 10 to 30 minutes.
• QuickFinder COVID-19/Flu Antigen Self-Test, Osang Healthcare, Pasadena, California. Displays result in 15 minutes.
• TyFast Flu A/B & COVID-19 Multiplex Rapid Test, CorDx, San Diego.  Displays result in 10 minutes.
• Speedy Swab™ Rapid COVID-19 + Flu A&B Antigen Test, Watmind, Jackson, Mississippi. Displays result in 15 minutes.
• WELLlife Covid-19/Influenza A&B Home Test, Wondfo Biotech, San Diego. Displays result in 10 minutes.

Authorized POC Multiplex Tests supported by RADx Tech ITAP

The following list includes POC molecular and antigen tests authorized for use in health care settings.

• iHealth COVID-19/Flu A&B Rapid Test Pro, iHealth Labs, Inc., Sunnyvale, California. Displays result in 15 minutes.
• Lucira by Pfizer COVID-19 & Flu Test, Pfizer Inc., New York. Molecular test displays result in 30 minutes.
• Osom® Flu SARS-CoV-2 Combo Test, Sekisui Diagnostics, San Diego. Antigen test displays result in 10 to 30 minutes.
• OHC COVID-19/Flu Antigen Test Pro, Osang Healthcare, Pasadena, California. Antigen test displays result in 15 minutes.
• TyFast Flu A/B & COVID-19 Multiplex Rapid Test, CorDx, San Diego.  Antigen test displays result in 10 minutes.
• Visby Medical Respiratory Health Test, Visby Medical, Inc., San Jose, California. Molecular test displays result in 30 minutes.
• Speedy Swab™ Rapid COVID-19/Influenza A&B Antigen Test, Watmind, Jackson, Mississippi.  Antigen test displays results in 15 minutes.
• WELLlife Covid-19/Influenza A&B Test, Wondfo Biotech, San Diego. Antigen test displays result in 10 minutes.

Details about the EUA for each test is available from the FDA: antigen tests and molecular tests.

About the Rapid Acceleration of Diagnostics (RADx®) initiative: The RADx initiative was launched on April 29, 2020, to speed innovation in the development, commercialization, and implementation of technologies for COVID-19 testing. The initiative has four programs: RADx Tech, RADx Advanced Technology Platforms, RADx Underserved Populations and RADx Radical. It leverages the existing NIH Point-of-Care Technology Research Network. The RADx initiative partners with federal agencies, including the Office of the Assistant Secretary of Health, Department of Defense, the Biomedical Advanced Research and Development Authority, and U.S. Food and Drug Administration. Learn more about the RADx initiative and its programs.

About the National Institute of Biomedical Imaging and Bioengineering (NIBIB): NIBIB’s mission is to improve health by leading the development and accelerating the application of biomedical technologies. The Institute is committed to integrating the physical and engineering sciences with the life sciences to advance basic research and medical care. NIBIB supports emerging technology research and development within its internal laboratories and through grants, collaborations, and training. More information is available at the NIBIB website.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit https://www.nih.gov/.