Summary
Cepheid has applied for an Emergency Use Approval (EUA) from the FDA for its molecular H1N1 (swine flu) test. Molecular based tests have been shown to be more accurate than rapid lateral flow assays available marketed by several manufacturers.
Analysis
Cepheid has a full schedule of new product introductions. Among these is a new molecular test for H1N1 (swine flu). The company has filed for an Emergency Use Approval (EUA) with the FDA. This new assay is a molecular based diagnostic test that can identify H1, H3, and novel H1N1 strains and provide test results in approximately 45 minutes. Molecular tests have been proven to be more accurate than rapid lateral flow assays. The increased sensitivity and specificity should provide Cepheid with important marketing and competitive advantages.
Cepheid intends to file for FDA clearance through the established FDA approval process following the FDA EUA.
Cepheid will join an ever growing list of diagnostic test manufacturers like Prodesse and commercial reference labs such as Quest Diagnostics that offer H1N1 assays.
For more information on H1N1 diagnostics, the companies that compete in this space and the high growth molecular diagnostics market segments, please contact your GLG representative today and schedule an individual consult.
Ken Powell consults with leading institutions through GLG
Analyses are solely the work of the authors and have not been edited or endorsed by GLG.
