FDA clearance sought for Roche’s Factor II and Factor V test on cobas 4800 system

Roche asserted that it has received FDA clearance for the cobas Factor II and Factor V Test for use on the cobas 4800 system. The test enables laboratories to simultaneously evaluate Factor II and Factor V gene mutations from a single patient sample, which can reduce hands-on time when testing patients for inherited thrombophilia.

Thrombophilia is a condition with a predisposition to develop thrombosis (e.g., blood clots) due to either an inherited or acquired defect in the coagulation system. Blood clots may form in either the venous or arterial vascular system and can lead to Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). Collectively, DVT and PE are known as Venous Thromboembolism (VTE).

Uwe Oberlaender, head of Roche Molecular Systems said “With this test, Roche can help labs generate results faster and with less hands-on time.”

The clearance of the new cobas Factor II and Factor V Test demonstrates Roche’s continued commitment to providing market-leading testing solutions for patients at risk of blood clots. The cobas Factor II and Factor V Test further expands the current menu of the cobas  4800 system, enabling labs to consolidate genomics, oncology, microbiology, and virology testing onto a single platform. The new test also complements the recent CE approval of the cobas t 511 and cobas t 711 coagulation analyzers for the central lab, making Roche a key partner for laboratories performing coagulation and thrombophilia testing.

The cobas Factor II and Factor V Test allows labs the flexibility to select the extraction method that best fits their workflow needs.