FLC | Two BARDA-funded OTC COVID-19 antigen tests receive FDA authorization

Two BARDA-funded OTC COVID-19 antigen tests receive FDA authorization

November 30, 2021

COVID-19 antigen diagnostic tests made by two Biomedical Advanced Research and Development Authority (BARDA) partners received authorization from the Food and Drug Administration (FDA) on November 22 for over-the-counter (OTC) use by people age 14 years or older with a self-collected nasal swab sample or people aged 2 years or older when an adult collects the nasal swab sample.

The InBios SCoV-2 Ag Detect Rapid Self-Test and the Becton, Dickinson and Company (BD) BD Veritor At-Home COVID-19 Test both can be used as:

A single test for people with COVID-19 symptoms (within the first five days of symptom onset for the InBios test)

A serial test for people without symptoms, meaning the test is done two times over three days.

The InBios test delivers results in about 20 minutes, while the BD Veritor test gives results in 15 minutes.

The BD Veritor test is among the five tests whose development is being funded by $24.7 M from BARDA, which was announced in October 2021. The funding, which can be extended to $40.3M as part of the collaboration, also covers the development of the BD MAX System Respiratory Panel, BD COR System Respiratory Panel, BD COR System Respiratory Panel plus Pan-Coronavirus, and BD MAX System Respiratory Panel plus Pan-Coronavirus.

The FDA reissued the EUA to authorize use of the BD Veritor At-Home COVID-19 Test as a single test without a prescription for people with COVID-19 symptoms. The test was already authorized for use as a serial test without a prescription by people with or without COVID-19 symptoms.

BARDA awarded nearly $600K to InBios in April 2020 for the rapid development of a point-of-care assay (test) to detect SARS-CoV-2 reactive antibodies in a blood sample.