Diagnostic healthcare specialist Quidel (QDEL) today announced it has received Emergency Use Authorization from the Food and Drug Administration for a rapid COVID-19 antigen test that returns results without the use of a test instrument. Shares were soaring 8% today on the news.
Quidel's QuickVue SARS Antigen test uses a nasal swab sample taken by a healthcare professional and returns results on a test strip within 10 minutes. The test is designed to be administered to patients suspected of COVID-19 within the first five days of the onset of symptoms and has a positive predictive agreement of 96.6%.
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Quidel expects the test will help meet urgent testing needs in school systems and rural locations, saying that it plans to reach a production run rate of 600 million tests by the end of next year. The company's Sofia 2 test instrument also supports a rapid antigen test for the SARS-CoV-2 virus, and the U.S. Department of Health and Human Services is buying 2,000 of the machines for placement in nursing homes.
Shares of Quidel have pulled back 34% from their high this summer as vaccines have come to the forefront and investors have become worried about competition from industry giant Abbott Laboratories (ABT 0.27%). Abbott has rapid test similar to Quidel's and announced last week a service to enable at-home use by consumers. But the demand for COVID-19 testing seems almost limitless at the moment, and investor interest in Quidel rebounded today.
