Cepheid and Instrumentation Laboratory announced that Health Canada has issued Cepheid a medical device license for its Xpert HemosIL FII & FV test. The test detects Factor II (FII) and Factor V Leiden (FV) genetic variations associated with thrombophilia, an increased risk of blood clots (thrombosis). Xpert HemosIL FII & FV delivers results in just over thirty minutes using a single GeneXpert cartridge. Developed and manufactured by Cepheid, the test will be available in Canada through a partnership with Instrumentation Laboratory (IL), the exclusive worldwide distributor for the Xpert HemosIL FII & FV test.
Given the complexity of traditional molecular diagnostics, clinical laboratories currently may wait up to a week for FII and FV genotyping, said John Bishop, Chief Executive Officer at Cepheid. The Xpert HemosIL FII & FV test will allow Canadian laboratories to perform the test on-demand — and integrate the results with other tests — providing physicians a more comprehensive thrombophilia profile of their patients.
FII and FV are the most common hereditary risk factors for venous thrombosis and key in the determination of genetic predisposition to the condition and the need for prophylactic treatment in high-risk patients. Testing for genetic and acquired defects, which may lead to thrombosis, is performed with the aid of both classic coagulation assays and molecular tests. In the past, many of these molecular tests could not be performed in a traditional hospital laboratory. Cepheid’s GeneXpert System enables on-demand FII and FV molecular tests to be easily performed in the hospital or independent clinical laboratory.
This license for Xpert HemosIL FII & FV allows us to begin coordinating the commercialization of the product in Canada, with our partner, Beckman Coulter, Inc. This unique test will be a valuable addition to our robust HemosIL product line of fully automated assays in Canadian hemostasis laboratories, said Josep Manent, Chief Executive Officer of IL. In combination with our ACL TOP Family of Testing Systems, the Xpert HemosIL test on the GeneXpert System will enable our Canadian customers to perform a complete thrombophilia work-up, rapidly, efficiently and accurately.
Xpert HemosIL FII & FV is the sixth GeneXpert-based test to receive a Health Canada Medical Device License.