Home > Press > Nanosphere Announces First FDA Cleared Genetic Test for Warfarin Sensitivity and Nanotechnology-based Molecular Diagnostics Platform
Verigene® System Designed to Make Genetic Testing Simpler and More Accessible
Nanosphere Announces First FDA Cleared Genetic Test for Warfarin Sensitivity and Nanotechnology-based Molecular Diagnostics Platform
NORTHBROOK, IL | Posted on September 18th, 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® System, a random access, molecular diagnostics workstation for nucleic acid and protein diagnostics. The company also announced FDA clearance of the Verigene System's first test to determine an individual's ability to metabolize the anti-coagulant medication warfarin, information critical to determining safe and appropriate dosing. This announcement marks clearance of a medical diagnostics platform based on nanotechnology for clinical use, as well as the first test cleared by the FDA to determine warfarin metabolism.
The FDA recently approved updated labeling information for the blood-thinner warfarin, sold under the brand name Coumadin. The new label explains that patients with variations in two genes, CYP2C9 and VCORC1, may respond differently to the drug. Genetic testing for these variations is expected to help doctors determine appropriate dosing levels for individual patients, thus lowering the risks of bleeding complications. Warfarin is the most prescribed oral anticoagulant in North America and Europe with more than 12 million new prescriptions from July 2006 to June 2007 and it is the second most common drug, after insulin, implicated in emergency room visits for adverse drug events.
The Verigene System uses patented gold nanoparticle technology to detect nucleic acid targets in a multiplex format. The system is comprised of two core instruments, the Verigene Reader and the Verigene Processor, and a single use disposable test cartridge. Nanosphere designed the Verigene System to allow for the simultaneous detection of multiple genetic targets in the same Verigene Test Cartridge format.
About Nanosphere, Inc.
Nanosphere develops, manufactures and markets an advanced molecular diagnostics platform, the Verigene System for direct genomic and ultra-sensitive protein detection. This easy to use and cost effective platform enables simple, low cost and highly sensitive genomic and protein testing on a single platform. Nanosphere is based in Northbrook, IL.
For more information, please click here
Michael McGarrity, 847-400-9000
Schwartz Communications, Inc.
Andrea tenBroek or Laura Kempke, 781-684-0770
Copyright © Business Wire 2007
If you have a comment, please Contact
Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.
NYU Researchers Break Nano Barrier to Engineer the First Protein Microfiber October 23rd, 2014
Iranian Scientists Apply Nanotechnology to Produce Surgery Suture October 23rd, 2014
RF Heating of Magnetic Nanoparticles Improves the Thawing of Cryopreserved Biomaterials October 23rd, 2014
Sopping up proteins with thermosponges: Researchers develop novel nanoparticle platform that proves effective in delivering protein-based drugs October 22nd, 2014
Haydale Secures Exclusive Development and Supply Agreement with Tantec A/S: New reactors to be built and commissioned by Tantec A/S represent another step forward towards the commercialisation of graphene October 24th, 2014
QuantumWise guides the semiconductor industry towards the atomic scale October 24th, 2014
Advancing thin film research with nanostructured AZO: Innovnano’s unique and cost-effective AZO sputtering targets for the production of transparent conducting oxides October 23rd, 2014
Strengthening thin-film bonds with ultrafast data collection October 23rd, 2014