SUBSCRIBE Blog with us: BLOGbiotech

GEN News Highlights

• Email
• Print
• Share
• More GEN News Highlights

Oct 29 2009, 11:12 AM EST

FDA Grants Emergency Use Authorization to Gen-Probe's PCR Test for the H1N1 Flu

GEN News Highlights

Gen-Probe has been granted an EUA (emergency use authorization) for the Prodesse ProFlu-ST™ to be used in CLIA high-complexity laboratories for detection of the 2009 H1N1 influenza virus. The test is aided by an algorithm that relies on seasonal influenza A/H1 and A/H3 virus results from a single sample in individuals who are diagnosed with influenza A by currently available devices.

Under the EUA, the agency has authorized the use of ProFlu-ST only during the H1N1 flu emergency, which is currently set to expire on April 26, 2010. The test becomes the first commercially available RT-PCR diagnostic that can detect and identify the 2009 H1N1 influenza virus, according to Gen-Probe. Test results are reportedly obtained in three hours using the assay; culture-based methods can take up to weeks to produce a result, the firm adds.

“This test complements nicely our FDA-cleared ProFlu+ Assay, which from a single sample, detects and discriminates influenza A virus, influenza B virus, and RSV (respiratory syncytial virus),” notes Andy Shrago, head of marketing for Prodesse products.

Both the ProFlu-ST and ProFlu+ tests were obtained through the acquisition of Prodesse, completed on October 21. Prodesse had three FDA 510(k)-cleared products and two additional CE-marked products in Europe.

Prodesse's ProFlu+ test was sanctioned by the FDA in January 2008 for the detection and discrimination of influenza A virus, influenza B virus, and RSV. Prodesse also sold assays for the clinical diagnosis of Clostridium difficile and human metapneumovirus in the U.S.

 

♦♦♦
Related News
Qiagen Releases Influenza A/H1N1 Detection Kit for Research Purposes (Sep. 10, 2009)
Warnex Develops Test to Detect Swine Flu Virus Mutation Linked to Tamiflu Resistance (Aug. 27, 2009)
Roche Launches Swine Flu Detection Kit for Research Purposes (May 14, 2009)
H1N1 Pandemic Is Here but Moderate in Severity (June 15, 2009)
Diatherix Releases Swine Flu Virus Test (May 7, 2009)

• Email
• Print
• Share
• More GEN News Highlights

Comment on this News:

Name:
Title:
Comment:
	HELP US FIGHT SPAMMING ROBOTS by answering the following simple question. It will verify you as a legitimate user wishing to post a comment. Thank you for your cooperation.

CAREER CENTER

WEBINARS

PODCASTS

MOST POPULAR