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Home > Press > Nanosphere Announces FDA Clearance of Second Molecular Diagnostics Assay

Abstract:
Hyper-coagulation Panel Designed to Test for Blood Coagulation Disorders

Nanosphere Announces FDA Clearance of Second Molecular Diagnostics Assay

NORTHBROOK, IL | Posted on October 16th, 2007

Nanosphere, 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 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.

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About Nanosphere, Inc.
Nanosphere is redefining 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. The Verigene System’s 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, IL.

For more information, please click here

Contacts:
Nanosphere, Inc.
Michael McGarrity, 847-400-9110

or
Schwartz Communications, Inc.
Andrea tenBroek or Laura Kempke, 781-684-0770

Copyright © Business Wire 2007

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