Nanosphere, Inc. has announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for the Verigene® F5 / F2 / MTHFR Nucleic Acid Test, which detects disease-associated gene mutations that can contribute to blood coagulation disorders and difficulties metabolizing folate (vitamin B-12).
This marks the second nanotechnology-based assay cleared by the FDA to run on the Verigene® System, following clearance in September of the company’s Verigene® Warfarin Metabolism Nucleic Acid Test.
The Verigene® F5 / F2 / MTHFR Nucleic Acid Test is the first FDA-cleared test for the identification of mutations in three specific genes that together can increase an individual’s risk for dangerous blood clots and their leading complication, stroke.
According to the National Hemophilia Foundation, more than 600,000 Americans die from abnormal blood clots each year. Patients that test positively for an increased risk of blood clots can be managed with anti-coagulant therapy such as warfarin. Hyper-coagulation tests for mutations associated with a predisposition to blood clots are currently among the most frequently conducted human genetic tests.
The test is available in single and multi target (multiplex) formats, allowing users to select the test cartridge that best fits the clinical indications for testing.