Nanotechnology Now

Our NanoNews Digest Sponsors



Heifer International

Wikipedia Affiliate Button


android tablet pc

Home > Press > Nanogen Submits 510(K) for Cystic Fibrosis Genetic Assay and NanoChip® 400 System

Abstract:
Nanogen, Inc. (Nasdaq:NGEN), developer of advanced diagnostic products, announced today that it has submitted the 510(K) to FDA for its Cystic Fibrosis Kit and NanoChip® 400 microarray system. The Cystic Fibrosis Kit is intended to be used for carrier testing in adults of reproductive age, as an aid in newborn screening, and in confirmatory diagnostic testing in newborns and children.

Nanogen Submits 510(K) for Cystic Fibrosis Genetic Assay and NanoChip® 400 System

SAN DIEGO, CA | Posted on April 17th, 2007

"The premarket notification of the NanoChip® system and the Cystic Fibrosis assay to the FDA is an important milestone for Nanogen," said Howard C. Birndorf, Nanogen's chairman and CEO. "This submission not only meets the commitment we made to the FDA, but also receiving 510(K) clearance will allow us to promote the system for use in clinical laboratories leading to increased revenue opportunities." The current submission is the first for the company's proprietary electronic microarray technology.

The genetic assay screens for 23 mutations which account for approximately 90 per cent of cystic fibrosis cases in the U.S. Caucasian population. The American College of Obstetrics and Gynecology (ACOG) and the American College of Medical Genetics (ACMG) have recommended that genetic testing for cystic fibrosis be offered to all couples in the U.S. currently planning a pregnancy. Cystic fibrosis is the most common genetic disease in the United States.

The NanoChip® 400 instrument is an automated multiplexing platform that laboratories use to detect genetic sequences. Tests can be performed using reagents supplied by Nanogen or laboratories can develop a variety of "homebrew" assays. The NanoChip instrument employs Nanogen's core microarray technology, which utilizes patented microfluidics and electronic technology to automate sample handling and detection of results.

####

About Nanogen, Inc.
Nanogen's advanced technologies provide researchers, clinicians and physicians worldwide with improved methods and tools to predict, diagnose, and ultimately help treat disease. The company's products include real-time PCR reagents, the NanoChip® electronic microarray platform and a line of rapid diagnostic tests. Nanogen's more than ten years of pioneering research involving nanotechnology holds the promise of miniaturization and continues to be supported for its potential for diagnostic and biodefense applications. For additional information please visit Nanogen's website at http://www.nanogen.com .

Forward-Looking Statement

This press release contains forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements, including whether patents owned or licensed by Nanogen will be developed into products, whether the patents owned by Nanogen offer any protection against competitors with competing technologies, whether products under development can be successfully developed and commercialized, whether results reported by our customers or partners can be identically replicated, and other risks and uncertainties discussed under the caption "Factors That May Affect Results" and elsewhere in Nanogen’s Form 10-K or Form 10-Q most recently filed with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Nanogen disclaims any intent or obligation to update these forward-looking statements.

For more information, please click here

Contacts:
Nanogen, Inc.
Robert Saltmarsh
Chief Financial Officer
858-410-4600
Suzanne Clancy
Corporate Communications
858-410-4688

or
Porter Novelli Life Sciences
Kim Richards
Media & Investor Relations
619-849-5377

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

Nanomedicine

The Pocket Project will develop a low-cost and accurate point-of-care test to diagnose Tuberculosis: ICN2 holds a follow-up meeting of the Project on September 18th - 19th September 18th, 2014

New non-invasive technique could revolutionize the imaging of metastatic cancer September 17th, 2014

Recruiting bacteria to be technology innovation partners: September 17th, 2014

Nanoscience makes your wine better September 17th, 2014

Announcements

Wear-resistant ceramic powder maximises component lifespan in high-stress applications: Innovnano’s nanostructured 3YSZ offers improved tribological performance for manufacturing components September 18th, 2014

IEEE International Electron Devices Meeting To Celebrate 60th Anniversary as The Leading Technical Conference for Advanced Semiconductor Devices September 18th, 2014

FEI Opens New Technology Center in Czech Republic: FEI expands its presence in Brno with the opening of a new, larger facility September 18th, 2014

Biosensors Get a Boost from Graphene Partnership: $5 Million Investment Supports Dozens of Jobs and Development of 300mm Fabrication Process and Wafer Transfer Facility September 18th, 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