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Cepheid (CPHD) Announces FDA-Clearance for Global Marketing of Blood Clot Test

Cepheid, a diagnostics company focused on the biothreat market, last week made a joint announcement with Instrumentation Laboratory (IL), a worldwide developer, manufacturer and distributor of vitro-diagnostics instruments, reporting that Cepheid has received clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert(R) HemosIL(R) FII & FV test.

According to the Centers for Disease Control and Prevention (CDCP), between 300,000 and 600,000 people have deep-vein thrombosis, or blood clots; additionally, 5 percent to 8 percent of people have thrombophilia, a condition leading to increased risk of thrombosis. Cepheid’s Xpert HemosIL FII and FB test detects thrombophilia, delivering results in roughly 30 minutes. Cepheid said IL’s experience in the market will allow for time-efficient testing, ultimately benefiting physicians and their patients.

“The Xpert HemosIL FII & FV test is the first product developed in conjunction with our partnering model to be marketed in the U.S.,” John Bishop, Cepheid’s CEO stated in the press release. “Programs such as this have been strategically developed to help provide incremental leverage in the development of a broad test menu for our GeneXpert System. IL is a leader in the hemostasis market and the Xpert HemosIL FII & FV test will enable laboratories to perform the test immediately — and integrate the results with those from other tests — providing physicians a more comprehensive thrombophilia profile of their patients.”

Previously, most molecular testing for genetic and acquired defects could not be performed in a traditional hospital laboratory; now, Cepheid’s GeneXpert System allows for speedy FII and FV molecular tests to be administered both in hospitals and independent clinical laboratories.

“The availability of an FDA cleared test for FII & FV polymorphisms that is rapid, accurate, easy to use and performed on-demand is important for several reasons,” said Alan H.B. Wu, PhD, chief of the Clinical Chemistry, Toxicology and Pharmacogenomics Laboratories at San Francisco General Hospital & Trauma Center and the University of California, San Francisco. “First, labs will likely save money because such testing is performed in national reference or academic molecular diagnostic labs, often at significant cost and with the inherent delays of send-out testing. Second, with a turnaround time of about 30 minutes for the genetic test, results can be made available in real-time, to facilitate discussions between physician and patient.”

Xpert HemosIL FII & FV is Cepheid’s eighth test to receive FDA clearance. While IL has been focusing on distributing Cepheid’s test in Europe since March 2008, the recent FDA approval will allow IL to exclusively distribute the product worldwide.

“The response to the Xpert HemosIL FII & FV test from our customers in Europe has been extremely positive. We are very pleased that laboratorians in the U.S. will now have the ability to perform, in combination with our ACL TOP(R) Family of systems, a complete thrombophilia work-up, rapidly, efficiently and accurately,” said Josep Manent, CEO of IL. “This is another example of IL’s dedication to providing innovation in hemostasis to our customers around the world.”

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