Nanotechnology Now

Our NanoNews Digest Sponsors



Heifer International

Wikipedia Affiliate Button


android tablet pc

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

NREL Announces New Center Directors to lead R&D, Analysis Efforts September 30th, 2014

A Heartbeat Away? Hybrid "Patch" Could Replace Transplants: TAU researcher harnesses gold nanoparticles to engineer novel biocompatible cardiac patch September 30th, 2014

How things coil: Researchers discover that simulation technology designed for Hollywood can be used as a predictive tool for understanding fundamental engineering problems September 29th, 2014

UT Arlington researchers develop transparent nanoscintillators for radiation detection for medical safety and homeland security September 29th, 2014

Nanomedicine

Speed at its limits September 30th, 2014

Ad-REIC vaccine: A magic bullet for cancer treatment September 30th, 2014

New Topical Hemostatic Agent: Neutral Self-Assembling Peptide Hydrogel September 30th, 2014

A Heartbeat Away? Hybrid "Patch" Could Replace Transplants: TAU researcher harnesses gold nanoparticles to engineer novel biocompatible cardiac patch September 30th, 2014

Announcements

Park Systems Announces Outsourced Analytical Services Including AFM Surface Imaging, Data Analysis and Interpretation September 30th, 2014

Ad-REIC vaccine: A magic bullet for cancer treatment September 30th, 2014

New Topical Hemostatic Agent: Neutral Self-Assembling Peptide Hydrogel September 30th, 2014

Chemical interactions between silver nanoparticles and thiols: A comparison of mercaptohexanol again September 30th, 2014

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



  Premium Products
NanoNews-Custom
Only the news you want to read!
 Learn More
NanoTech-Transfer
University Technology Transfer & Patents
 Learn More
NanoStrategies
Full-service, expert consulting
 Learn More














ASP
Nanotechnology Now Featured Books




NNN

The Hunger Project







© Copyright 1999-2014 7th Wave, Inc. All Rights Reserved PRIVACY POLICY :: CONTACT US :: STATS :: SITE MAP :: ADVERTISE