InBios Receives FDA EUA for Home Use Antigen Test for COVID-19

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InBios International Inc., a leading developer of diagnostic tests for emerging infectious diseases, announced today that it received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) allowing the company to market its SCoV-2 Ag Detect Rapid Self-Test, a three-step home use antigen test for COVID-19 that provides results in ~20 minutes.

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Designed to be extremely simple to use for consumers who are not familiar with self-testing, the SCoV-2 Ag Detect Rapid Self-Test, will soon be available for purchase without a prescription in major retail stores and online through e-commerce channels.

As the demand for fast, reliable self-tests for COVID-19 antigen remains high, InBios International Inc., a leading developer of diagnostic tests for emerging infectious diseases, announced today that it received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) allowing the company to market its SCoV-2 Ag Detect Rapid Self-Test, a three-step home use antigen test for COVID-19 that provides results in ~20 minutes.

The nasal swab test, designed to be extremely simple to use for consumers who are not familiar with self-testing, will soon be available for purchase without a prescription in major retail stores and online through e-commerce channels. It may be used for self-testing by individuals 14 years and older, or with adult-collected nasal swabs from children as young as 2 years old. The test can be useful in a number of scenarios, helping an individual determine in three easy steps if they are safe to go to work, attend school or simply carry on with daily interactions with others.

The SCoV-2 Ag Detect Rapid Self-Test kit features the same SARS-CoV-2 rapid antigen test that received an EUA from the FDA for use in professional settings in May 2021. The test, which can be purchased in single test or multi-pack configurations, features a unique ease-of-use patent-pending design and uses shallow nasal swabs with no instrumentation required to read results. It is designed for use with symptomatic and asymptomatic serial testing.

“As routine testing by rapid antigen tests has proven to be an effective tool in diagnosing COVID-19, self-administered tests that are accurate, fast and easy to perform serve as an early warning system, helping individuals determine their current health status and make good decisions to protect themselves, their families and their communities,” said Dr. Syamal Raychaudhuri, InBios’ chief scientific officer. “We’re pleased to continue to be able to add to our portfolio of COVID-19 diagnostics and meet the demand for rapid, at-home testing.”

The clinical performance of the SCoV-2 Ag Detect Rapid Self-Test, a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 Nucleoprotein antigen, was evaluated in a simulated home environment study in the U.S. The study showed that the test accurately determined 85.71% of those who were positive (PPA) and 100% of those who were negative (NPA) for SARS-CoV-2 antigen for nasal swab samples collected from symptomatic patients within 5 days post symptom onset (PSO).

Funding to achieve EUA for the SCoV-2 Ag Detect Rapid Self-Test comes in part from a $12.7 million contract with the U.S. Army Medical Material Development Activity (USAMMDA) Warfighter Protection and Acute Care (WPAC) Program Management Office with funding provided by the Defense Health Agency (DHA) through the CARES Act and the U.S. Department of Health and Human Services (HHS), Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response awarded in 2020 under contract W81XWH-16-D-0009/Task Order W81XWH-20-F-0253.

While the SCoV-2 Ag Detect Rapid Self-Test has not been FDA cleared or approved, it has been authorized by FDA under an EUA. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

For more information about InBios COVID-19 tests, visit: http://www.inbios.com/covid-19/.

For more information on COVID-19, please visit http://www.cdc.gov or http://www.who.int.

About InBios: InBios International Inc. specializes in the design, development and manufacture of diagnostic assays for emerging infectious diseases and biothreats. Located in Seattle, Washington, InBios offers superior quality products which are accurate, easy to use and cost effective. InBios is GMP compliant, FDA registered, USDA licensed and ISO 13485:2016 certified. For more information, visit http://www.inbios.com.

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Wendy Bagnato

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InBios
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