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