UPDATE 1-Cepheid gets FDA emergency approval for H1N1 assay

Mon Jan 4, 2010 8:00am EST

* Xpert Flu A panel test gets EUA

* Test for use in CLIA 'moderate complexity' labs

* Co to continue development of expanded influenza panel test

Jan 4 (Reuters) - Cepheid (CPHD.O) said it has been granted Emergency Use Authorization from U.S. health regulators for its H1N1 influenza assay Xpert Flu A Panel.

The test runs on Cepheid's GeneXpert System and identifies the H1N1 influenza virus in less than one hour.

The Food and Drug Administration can only grant emergency use authorization for the duration of the emergency, which is currently set to expire on April 26 this year, unless it is terminated sooner or renewed.

Cepheid said it will continue development of an expanded influenza panel product and it expects to submit a separate marketing application this year.

Shares of Cepheid closed at $12.48 Thursday on Nasdaq. (Reporting by Jennifer Robin Raj in Bangalore; Editing by Jarshad Kakkrakandy)

Related Quotes and News

Company
Price
Related News
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.