Cepheid announced today that it received CE mark approval for its Xpert Xpress CoV-2/Flu/RSV Plus rapid molecular diagnostic. Sunnyvale, California-based Cepheid last month received FDA emergency use authorization (EUA) for the Xpert Xpress CoV-2/Flu/RSV Plus diagnostic. The company designed its Xpert Xpress Plus as a rapid molecular diagnostic test for the qualitative detection of the viruses […]
Cepheid
Cepheid wins EUA for new version of COVID-19, flu, RSV combination diagnostic
Cepheid announced today that it received FDA emergency use authorization (EUA) for its Xpert Xpress CoV-2/Flu/RSV Plus diagnostic. Sunnyvale, California-based Cepheid designed its Xpert Xpress Plus as a rapid molecular diagnostic test for the qualitative detection of the viruses causing COVID-19, Flu A, Flu B and respiratory syncytial virus (RSV). Nearly one year ago, the […]
Cepheid wins EUA for COVID-19, flu, RSV combination test
Cepheid announced today that it received FDA emergency use authorization for its Xpert Xpress SARS-CoV-2/Flu/RSV diagnostic test. The Danaher Corp. (NYSE:DHR) subsidiary’s rapid molecular diagnostic test for detecting the viruses causing COVID-19, Flu A, Flu B and RSV infections in a single patient can be used in tandem with any of Cepheid’s GeneXpert systems across the […]
AdvaMed unveils COVID-19 diagnostic supply registry
AdvaMed announced today that it created a comprehensive national COVID-19 diagnostic supply registry to aid state and federal pandemic responses. According to a news release, AdvaMed is launching the registry in partnership with 13 commercial diagnostics manufacturers: Abbott (NYSE:ABT), Becton Dickinson (NYSE:BDX), bioMérieux, Bio-Rad Laboratories (NYSE:BIO), Beckman Coulter, Cepheid, Hologic (NSDQ:HOLX), Ortho Clinical Diagnostics, Qiagen (NYSE:QGEN), Roche Diagnostics, Sekisui Diagnostics, […]
Cepheid wins emergency use nod from FDA for bedside coronavirus test
Danaher Corp. (NYSE:DHR) subsidiary Cepheid announced that it received emergency use authorization from the FDA for its bedside Xpert Xpress SARS-CoV-2 test for detecting the virus causing the COVID-19 outbreak. The rapid molecular diagnostic test is designed to detect the SARS-CoV-2 virus causing coronavirus while operating on any of Cepheid’s GeneXpert systems worldwide, with a detection […]
Danaher to buy Cepheid in $4B deal to expand in diagnostics
(Reuters) –Danaher Corp. (NYSE:DHR) said on Tuesday it would buy molecular diagnostics company Cepheid in a deal valued at $4 billion, including debt, to strengthen its diagnostics business. Danaher will pay $53 per share in cash, a premium of 54% to Cepheid’s close of $34.42 on Friday. Danaher, which develops technology for the dental, life […]
FDA approves spine sealant from Covidien | Regulatory roundup
Here’s a roundup of companies announcing clearances and approvals from the FDA and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.
Earnings roundup: Thoratec profits leap 58 percent
MassDevice keeps a close eye on public medical device companies, tracking their quarterly sales and earnings reports. For the most recent filings, check out our Earnings Roundup, where we collect each quarter’s reports.
Here’s a quick rundown of a few releases over the past couple days:
Cepheid’s Q4 sales rise, net loss falls
Cepheid (NSDQ:CPHD) posted fourth-quarter sales of $49.2 million for the three months ended Dec. 31, 2009, up 30.1 percent compared with $37.8 million during the same period in 2008. Cepheid pared its net loss for the quarter by 29.2 percent to $4.3 million, compared with $6.1 million during Q4 2008:
