New GeneXpert(R)-Based Test to Assess Genetic Risk of Thrombosis Improves Time to Result and Eliminates Delays Associated with Batch Processing
SUNNYVALE, Calif., and LEXINGTON, Mass., Feb. 25 /PRNewswire-FirstCall/ -- Cepheid (Nasdaq: CPHD) and Instrumentation Laboratory (IL), a leading clinical diagnostics company, today announced the release of the Xpert (TM) HemosIL(R) FII & FV assay as a European CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices. Delivering results in just over thirty minutes with a single GeneXpert(R) cartridge, the Xpert HemosIL FII & FV assay detects Factor II (FII) and Factor V Leiden (FV) genetic variations associated with thrombophilia, an increased risk of blood clots (thrombosis). Developed and manufactured by Cepheid, the test is expected to be available for sale beginning March 4th through IL, the exclusive worldwide distributor for the Xpert HemosIL FII & FV assay.
Xpert HemosIL FII & FV is the first test to be commercialized under the exclusive development and distribution agreement for hemostasis molecular diagnostic tests, entered into by IL and Cepheid in April 2007.
"Given the complexity of traditional molecular diagnostics, clinical
laboratories currently may wait up to a week for FII and FV genotyping. The
Xpert HemosIL FII & FV assay will allow laboratories to perform the test as
needed -- and integrate the results with other tests -- providing
physicians a comprehensive thrombophilia profile of their patients," said
Cepheid Chief Executive Officer John Bishop. "Given the strength of its
HemosIL line of hemostasis assays, IL is the ideal partner for the
distribution of this and potentially other important tests for the
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