US Food and Drug Administration Approves Zika Test

By Douglas A. McIntyre Updated Jan 13, 4:10AM EST · Published Aug 29, 6:37AM EDT

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US Food and Drug Administration Approves Zika Test — © Thinkstock

From PR Newswire:

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the LightMix^® Zika rRT-PCR Test. The product is for use in patients meeting CDC Zika virus clinical criteria and/or CDC Zika virus epidemiological criteria. The test is used for the detection of Zika virus in EDTA plasma or serum samples using Roche’s LightCycler^® 480 Instrument II or cobas z 480 Analyzer.

“The LightMix Zika test is an easy-to-use molecular diagnostic test that enables healthcare professionals to quickly detect the virus,” said Uwe Oberlaender, Head of Roche Molecular Diagnostics. “As a leader in diagnostics, Roche is committed to providing testing solutions for the world’s most challenging healthcare emergencies. The FDA’s granting of this EUA supports our commitment to help healthcare professionals who are working to combat this serious disease.”

In addition to the LightMix^® Zika rRT-PCR Test, Roche has also developed the cobas® Zika Test for use with the cobas® 6800/8800 Systems. This test is available under an Investigational New Drug Application (IND) protocol to initiate collection and testing of blood samples for screening. It is currently being utilized in blood centres in the United States.

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About the Author Douglas A. McIntyre →

Douglas A. McIntyre is the co-founder, chief executive officer and editor in chief of 24/7 Wall St. and 24/7 Tempo. He has held these jobs since 2006.

McIntyre has written thousands of articles for 24/7 Wall St. He is an expert on corporate finance, the automotive industry, media companies and international finance. He has edited articles on national demographics, sports, personal income and travel.

His work has been quoted or mentioned in The New York Times, The Wall Street Journal, Los Angeles Times, The Washington Post, NBC News, Time, The New Yorker, HuffPost USA Today, Business Insider, Yahoo, AOL, MarketWatch, The Atlantic, Bloomberg, New York Post, Chicago Tribune, Forbes, The Guardian and many other major publications. McIntyre has been a guest on CNBC, the BBC and television and radio stations across the country.

A magna cum laude graduate of Harvard College, McIntyre also was president of The Harvard Advocate. Founded in 1866, the Advocate is the oldest college publication in the United States.

TheStreet.com, Comps.com and Edgar Online are some of the public companies for which McIntyre served on the board of directors. He was a Vicinity Corporation board member when the company was sold to Microsoft in 2002. He served on the audit committees of some of these companies.

McIntyre has been the CEO of FutureSource, a provider of trading terminals and news to commodities and futures traders. He was president of Switchboard, the online phone directory company. He served as chairman and CEO of On2 Technologies, the video compression company that provided video compression software for Adobe’s Flash. Google bought On2 in 2009.