On Aug. 22, 2021, InBios announced that laboratory studies suggest its SCoV-2 Ag Detect Rapid Test detected the Delta variant (lineage B.1.617.2), which was responsible for a rapid rise of infections and deaths in the US and around the world. Initial studies suggested that InBiosﾒ point-of-care antigen test will detect the Delta variant at rates similar to the USA-WA1-2020 isolate that was used to develop the assay.

According to the Centers for Disease Control and Prevention, the Delta variant is more infectious and is leading to increased transmissibility when compared to other variants, even in vaccinated individuals. The Delta variant, first identified in India, is now estimated to make up 86% of all sequenced COVID-19 cases in the U.S. For the first time since February, the United States is averaging more than 100,000 new COVID-19 cases a day.

InBios SCoV-2 Ag Detect Rapid Test received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) in May 2021. Funding to achieve EUA for the SCoV-2 Ag Detect Rapid Test comes in part from a $12.7 million contract with the U.S. Army Medical Materiel Development Activity with funding provided by the Defense Health Agency (DHA) through the CARES Act and the Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA) awarded in 2020. The test is simple and fast – the patent-pending design features a direct nasal swab to cassette format. It requires no instrumentation or transport media step and can be performed on-site with results delivered in about 20 minutes.

This product has not been FDA cleared or approved but has been authorized by FDA under an EUA for use by authorized laboratories. 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.