Test Kits for Detection of Thrombophilia

Both kits have been cleared by the U.S. Food and Drug Admnistration (FDA).

The tests, from Roche Diagnostics (Basel, Switzerland), have been specifically developed for real-time polymerase chain reaction (PCR) using Roche's LightCycler instrument. Inherited thrombophilia predisposes an individual to thrombotic events such as venous thrombosis, the third most common cardiovascular disease. The American College of Medical Genetics and the College of American Pathologists have issued consensus statements recommending measurement of heritable thrombophilic risk factors such as Factor V Leiden and Prothrombin G20210A in patients with suspected thrombophilia.

"Creating the first FDA-cleared human DNA-based genetic disorder tests demonstrates the leadership of Roche in molecular diagnostics, and is symbolic of the developments Roche Diagnostics continues to achieve on this 20th anniversary of PCR,” noted Heino von Prondzynski, head of Roche Diagnostics.