Cepheid Receives FDA Authorization with CLIA Waiver for Xpert® HCV [Yahoo! Finance]
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Danaher Corporation (DHR)
Last danaher corporation earnings: 1/30 06:00 am
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Source: Yahoo! Finance
received FDA De Novo marketing authorization and Clinical Laboratory Improvement Amendments (CLIA) Waiver approval for Xpert ® HCV, the only molecular test in the US to detect hepatitis C virus RNA directly from a human capillary whole blood (fingerstick) sample. The Xpert HCV test is performed on the GeneXpert Xpress System. In the United States , 2.4 million people are estimated to be living with hepatitis C and more than half of the people with HCV do not know that they have the virus . An HCV RNA test at the point of care can simplify testing algorithms, increase diagnosis rates, and support timely linkage to care and treatment. The Viral Hepatitis National Strategic Plan for the United States calls for greater than 80% of people with hepatitis C to achieve viral clearance by 2030 . Currently, the clinical care pathway for detection of hepatitis C faces many barriers, including complicated multi-step diagnostic algorithms based on antibody screening and RNA confirmation . Thes
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News
- The best TVs under $500 in 2024 [Business Insider]Business Insider
- FDA approves Cepheid's Xpert HCV test and GeneXpert Xpress System [Yahoo! Finance]Yahoo! Finance
- Cepheid Receives FDA Authorization with CLIA Waiver for Xpert® HCVPR Newswire
- X-Rite Autura Ink Wins PRINTING United Alliance 2024 Pinnacle Product Award [Yahoo! Finance]Yahoo! Finance
- Danaher Co. (NYSE: DHR) was downgraded by analysts at StockNews.com from a "buy" rating to a "hold" rating.MarketBeat
DHR
Earnings
- 4/23/24 - Beat
DHR
Sec Filings
- 6/20/24 - Form 8-K
- 6/7/24 - Form 11-K
- 5/17/24 - Form 4
- DHR's page on the SEC website