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Posted: October 17, 2007
Nanosphere Announces FDA Clearance of Second Molecular Diagnostics Assay
(Nanowerk News) anosphere, Inc., a nanotechnology-based molecular diagnostics company, today 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 companyís 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 individualís 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.
About Nanosphere, Inc.
Nanosphere is redefining molecular diagnostics with a nanotechnology-based platform that will enable earlier detection and treatment of disease. The companyís direct genomic testing and ultra-sensitive protein detection technologies permit the development of new biomarkers and measurement of existing biomarkers at concentrations undetectable by todayís diagnostic technologies. The Verigene®: Systemís simplicity, ease of use and flexibility allow customers to perform molecular diagnostic testing in virtually any setting. Nanosphere is privately held and based in Northbrook, Ill. Additional information is available at http://www.nanosphere.us/