Genetic Assay and NanoChip Microarray System Screen for Cystic Fibrosis

A genetic assay screens for 23 mutations that account for approximately 90% of cystic fibrosis cases in the U.S. Caucasian population. A new microarray system is an automated multiplexing platform that laboratories use to detect genetic sequences.

Nanogen, Inc. (San Diego, CA, USA), developer of advanced diagnostic products has submitted the 510(K) to the U.S. Food and Drug Administration (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.

"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 American College of Obstetrics and Gynecology (ACOG; Washington, DC, USA) and the American College of Medical Genetics (ACMG; Bethesda, MD,USA) have recommended that genetic testing for cystic fibrosis be offered to all couples in the United States 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.


Related Links:
Nanogen
American College of Obstetrics and Gynecology
American College of Medical Genetics