Test Detects Mutations Contributing to Blood Coagulation Disorders

The Verigene F5 / F2 / MTHFR (methylenetetrahydrofolate reductase) nucleic acid test identifies 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 U.S. 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. The Verigene system's simplicity, ease of use and flexibility allow customers to perform molecular diagnostic testing in virtually any setting.

Nanosphere, Inc. (Northbrook, IL, USA) announced that it has received clearance from the U.S. Food and Drug Administration (FDA; Rockville, MD, USA) for the Verigene F5 / F2 / MTHFR A nucleic acid test. This marks the second nanotechnology-based assay cleared by the FDA to run on the Verigene system, following clearance in September 2007, of the company's Verigene warfarin metabolism nucleic acid test.

Nanosphere is developing molecular diagnostics with a nanotechnology-based platform that will enable earlier detection and treatment of disease. The company's direct genomic testing and ultra-sensitive protein detection technologies permit the development of new biomarkers and measurement of existing biomarkers at concentrations undetectable by today's diagnostic technologies.


Related Links:
Nanosphere, Inc.
U.S. Food and Drug Administration