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FDA Clears Roche Factor II, Factor V Gene Mutation Test for Inherited Thrombophilia

NEW YORK (GenomeWeb) – Roche said today that the US Food and Drug Administration has granted clearance for its multiplex Factor II and Factor V test for use on the Cobas 4800 system, which performs real-time PCR analysis for mid- to high-volume labs.

The test enables laboratories to simultaneously assess Factor II and Factor V gene mutations from a single patient sample. That can reduce hands-on time when clinicians test for inherited thrombophilia, a condition that predisposes patients to developing blood clots due to an inherited or acquired defect in the coagulation system, Roche said.

Uwe Oberlaender, head of Roche Molecular Systems, said in a statement, "Patients and their caregivers rely on genetic test results to accurately manage their risk for blood clots. "With this test, Roche can help labs generate results faster and with less hands-on time."

The new test, which can perform flexible reporting of both Factor II and Factor V gene mutations, represents a "significant system and workflow efficiency upgrade" for customers using Roche's LightCycler PCR system for Factor II and Factor V testing, the firm said. 

Laboratories performing the cleared test will be able to report one or both Factor V and Factor II genotypes from one well, streamlining the testing workflow and minimizing additional testing, Roche said. The efficient test design enables labs to report on up to 94 patient samples and 188 results per 90 minutes of testing.

Roche noted that the clearance expands the menu of the Cobas 4800 system and enables labs to consolidate genomics, oncology, microbiology, and virology testing onto a single platform. The firm noted that the test also complements a recent CE approval of the Cobas t 511 and Cobas t 711 coagulation analyzers, which are suitable for central labs performing coagulation and thrombophilia testing.