FDA Gives Emergency Use Authorization for New SARS-CoV-2 Molecular Test from Cepheid

Mar 30, 2020 | Coronavirus, COVID-19, Diagnostics, Molecular Test, Testing

FDA Gives Emergency Use Authorization for New SARS-CoV-2 Molecular Test from Cephid

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization for a rapid, near-patient test for the detection of the 2019 novel coronavirus that causes COVID-19. Cepheid’s Xpert® Xpress SARS-CoV-2 is now approved for emergency use.

What is Cepheid’s Xpert® Xpress SARS-CoV-2?

It is an automated molecular test for the qualitative detection of COVID-19. The test leverages the design principles of their current product Xpert® Xpress Flu/RSV cartridge technology, in which multiple regions of the viral genome are targeted. The test can provide rapid detection of the current pandemic coronavirus SARS-CoV-2 in approximately 45 minutes with less than a minute of hands-on time to prepare the sample.

Where can the test be used?

The test can be utilized in multiple settings where actionable test results are needed to make informed treatment decisions quickly. The test delivers point-of-care results with the same level of performance seen in reference labs. 

What is required for this test?

Well, it would appear that the test requires the purchase of Cepheid’s GeneXpert Systems—currently with a worldwide footprint of over 23,000 placements.

About Cepheid (owned by Danaher)

Based in Sunnyvale, California, Cepheid is a leading molecular diagnostics company that is an operating company within Danaher Corporation’s (NYSE: DHR) Diagnostics platform. Cepheid is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company’s solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as when managing infectious diseases and cancer.   

Cepheid is a unit of conglomerate Danaher. which acquired them in 2016.

Source: Cepheid

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