Nanotechnology Now

Our NanoNews Digest Sponsors

Heifer International

Wikipedia Affiliate Button

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.

####

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

If you have a comment, please Contact us.

Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.

Bookmark:
Delicious Digg Newsvine Google Yahoo Reddit Magnoliacom Furl Facebook

Related News Press

Govt.-Legislation/Regulation/Funding/Policy

Nanobiotix Publishes Positive Phase 2/3 Data For Nanomedicine in Soft Tissue Cancer (Webcast June 22) June 22nd, 2018

Alzheimer's breakthrough: Brain metals that may drive disease progression revealed: In brains affected by Alzheimer's, researchers identify chemically reduced iron species, with mineral forms including a magnetic iron oxide June 22nd, 2018

Collaboration yields discovery of 12-sided silica cages June 20th, 2018

Powering the 21st Century with Integrated Photonics: UCSB-Led Team Selected for Demonstration of a Novel Waveguide Platform Which is Transparent Throughout the MWIR and LWIR Spectral Bands June 19th, 2018

Nanomedicine

Nanobiotix Publishes Positive Phase 2/3 Data For Nanomedicine in Soft Tissue Cancer (Webcast June 22) June 22nd, 2018

Alzheimer's breakthrough: Brain metals that may drive disease progression revealed: In brains affected by Alzheimer's, researchers identify chemically reduced iron species, with mineral forms including a magnetic iron oxide June 22nd, 2018

Collaboration yields discovery of 12-sided silica cages June 20th, 2018

JPK talks with Dr Frank Lafont, Director of the BioImaging Center Lille (BICeL) about the use of the NanoWizard® AFM together with fluorescence microscopy in the study of living cells June 19th, 2018

Announcements

Northwestern researchers achieve unprecedented control of polymer grids: Materials could find applications in water purification, solar energy storage, body armor June 22nd, 2018

Nanobiotix Publishes Positive Phase 2/3 Data For Nanomedicine in Soft Tissue Cancer (Webcast June 22) June 22nd, 2018

Alzheimer's breakthrough: Brain metals that may drive disease progression revealed: In brains affected by Alzheimer's, researchers identify chemically reduced iron species, with mineral forms including a magnetic iron oxide June 22nd, 2018

Collaboration yields discovery of 12-sided silica cages June 20th, 2018

NanoNews-Digest
The latest news from around the world, FREE



  Premium Products
NanoNews-Custom
Only the news you want to read!
 Learn More
NanoStrategies
Full-service, expert consulting
 Learn More











ASP
Nanotechnology Now Featured Books




NNN

The Hunger Project