Cepheid accelerates development of rapid flu A panel test
22 September 2009
Cepheid (NASDAQ: CPHD) has announced the accelerated development of a
Flu A (Influenza Virus) Panel test for use on the GeneXpert System. The
test will be designed to provide 45-minute identification of Flu A
infection, with specific presumptive identification of seasonal H1,
seasonal H3, and H1N1 novel strain types.
Following review of the Request for Consideration for Emergency Use
Authorization (EUA) by the US Food & Drug Administration (FDA), the test
is expected to be authorized for use during the upcoming influenza
season, with product shipments beginning in January 2010.
“In reviewing the needs of the healthcare system, it became apparent
that the GeneXpert is a key potential solution to the universal need for
rapid and accurate flu testing on both a centralized and disseminated
basis,” said John Bishop, Cepheid's Chief Executive Officer. “In
recognition of this universal need, we reprioritized longer term
projects within the company in order to deliver this product in a timely
Subsequent to the EUA request for consideration by the FDA, the test
will be made available in Europe as a CE IVD product.
“Currently, laboratories do not have a rapid test to discriminate
among the multiple influenza strains expected to be present this flu
season — each of which have different antiviral drug susceptibilities,”
said David Persing, MD, PhD, Cepheid’s Executive Vice President, Chief
Medical & Technology Officer.
“To make this test available as quickly as possible, we plan to
accelerate development by leveraging the work completed on a previous
influenza project supported through a 2007 contract with the Department
of Health and Human Services (HHS) and Centers for Disease Control and
Following EUA request to the FDA, development of Cepheid’s Flu Panel
test will continue by adding additional target identification for Flu B.
For that product, a separate 510(k) submission is expected in 2010.
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