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Oct 16, 2007

Nanosphere Obtains FDA Approval for Diagnostic Instrument Related to Blood Coagulation Disorders

  • Nanosphere received FDA clearance for its second molecular diagnostic assay that predicts a person’s risk of developing blood clots. The Verigene® F5/F2/MTHFR Nucleic Acid Test detects disease-associated gene mutations that can contribute to blood coagulation disorders and difficulties metabolizing folate (vitamin B-12).

    This system identifies variations in three genes that together reportedly increase an individual's risk of developing blood clots and related complications such as stroke. The instrument is available in single and multitarget (multiplex) formats.
    In September, the company obtained approval for its first test to determine an individual’s ability to metabolize the anticoagulant medication, warfarin.



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