Nanotechnology Now





Heifer International

Wikipedia Affiliate Button


DHgate

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

Collaboration could lead to biodegradable computer chips May 28th, 2015

Nanotechnology identifies brain tumor types through MRI 'virtual biopsy' in animal studies: If results are confirmed in humans, tumor cells could someday be diagnosed by MRI imaging and treated with tumor-specific IV injections; new NIH grant will fund future study May 27th, 2015

Who needs water to assemble DNA? Non-aqueous solvent supports DNA nanotechnology May 27th, 2015

One step closer to a single-molecule device: Columbia Engineering researchers first to create a single-molecule diode -- the ultimate in miniaturization for electronic devices -- with potential for real-world applications May 25th, 2015

Nanomedicine

New electronic stent could provide feedback and therapy — then dissolve May 27th, 2015

Arrowhead to Present at Jefferies 2015 Healthcare Conference May 27th, 2015

Seeing the action: UCSB researchers develop a novel device to image the minute forces and actions involved in cell membrane hemifusion May 27th, 2015

Nanotechnology identifies brain tumor types through MRI 'virtual biopsy' in animal studies: If results are confirmed in humans, tumor cells could someday be diagnosed by MRI imaging and treated with tumor-specific IV injections; new NIH grant will fund future study May 27th, 2015

Announcements

Collaboration could lead to biodegradable computer chips May 28th, 2015

Nanotechnology identifies brain tumor types through MRI 'virtual biopsy' in animal studies: If results are confirmed in humans, tumor cells could someday be diagnosed by MRI imaging and treated with tumor-specific IV injections; new NIH grant will fund future study May 27th, 2015

Who needs water to assemble DNA? Non-aqueous solvent supports DNA nanotechnology May 27th, 2015

Controlled Release of Anticorrosive Materials in Spot by Nanocarriers May 27th, 2015

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