Xtrava Health Receives Emergency Use Authorization for their Rapid SPERA™ COVID-19 Ag Test
Oct 22, 2021
USA - English
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SANTA CLARA, Calif., Oct. 21, 2021 /PRNewswire/ -- Xtrava Health , a health technology company, today announced the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for their SPERA™ COVID-19 Ag Test. The easy-to-use, rapid lateral flow immunoassay directly detects the COVID-19 causing virus in shallow nasal samples authorized for use at the point of care. The test is authorized for use in congregate settings such as schools, nursing homes, workplaces as well as doctor's offices. The main advantage of the test is the rapid results in 15 minutes without the long wait for results. The SPERA™ COVID-19 Ag Test is top-ranked for its ease-of-use. The test only requires shallow nasal swabs. In the presence of the virus, a line is clearly visible to the eye within 15 minutes or less. More accurate than most rapid tests currently on the market, the SPERA COVID-19 Ag Test provides 92% sensitivity (the true positive rate) and 97% specificity (the true negative rate). A study conducted by the National Institutes of Health (NIH) in collaboration with Emory University, Georgia Institute of Technology, and Children's Healthcare of Atlanta confirmed that the test detects all major circulating variants including the Delta, Lambda, and Mu. "The rise in COVID-19 cases from emerging variants has increased the demand for accurate, rapid tests, especially among schools and workplaces that have mandated frequent testing," said Sameh Sarhan, CEO of Xtrava Health. "With the help of our top-tier Japanese partner Denka, we can now deliver millions of rapid antigen tests annually to the market, ensuring simple and accurate COVID-19 tests are more readily available to alleviate the shortage in tests." "We have been working closely with our supply chain and logistics partners to ensure fast delivery of our high-quality tests, to meet the current market demand," adds Iman Sadreddin, Xtrava Health's COO. Xtrava Health was awarded a $6.2 million contract by the NIH under the Rapid Acceleration of Diagnostics (RADxSM) initiative to expedite the launch of its SPERA™ COVID-19 antigen test. This project was funded in part by the NIH RADxSM initiative with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92021C00002. SPERA™ COVID-19 Ag Test
The SPERA™ COVID-19 Ag Test has not been FDA cleared or approved but has been authorized by FDA under 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 IVDs 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. About Xtrava Health
Xtrava Health is a Silicon Valley company, founded in 2014, on a mission to bridge the gap between diagnostics and everyday users. Leveraging unique technology and strategic global partnerships, Xtrava Health develops, manufactures, and commercializes easy-to-use, accurate, and affordable diagnostic products for health professionals and at-home use. Xtrava Health is currently on the forefront in the battle against the COVID-19 pandemic.