SAN DIEGO, March 23 /PRNewswire-FirstCall/ -- Nanogen, Inc. , developer of advanced diagnostic products, announced today it has expanded its molecular reagent product portfolio with analyte specific reagents (ASRs) designed to detect 23 wild type and mutation sequences associated with cystic fibrosis (CF). The U.S. launch of the product is occurring at the American College of Medical Genetics (ACMG) meeting taking place March 23-26 in San Diego, California, where medical geneticists and other health care professionals can discuss the new products with Nanogen experts.
The new CFTR ASR products are part of the company’s growing NGEN(TM) brand of reagents for molecular applications. The NGEN(TM) CFTR ASR can be used by CLIA laboratories to develop and validate assays to genotype the 23 mutations and polymorphisms recommended by the American College of Obstetricians and Gynecologists (ACOG) and the ACMG for CF carrier screening. Assays using NGEN(TM) CFTR ASRs, once validated by the laboratory, can be used as a clinical diagnostic test. ACOG has recommended, as a standard of care, that all Caucasians or Ashkenazi Jews be offered CF carrier screening prior to conceiving a child. The products will be CE marked in Europe for in vitro diagnostics and will be available in the United States as ASRs for which analytical and performance characteristics are not established.
“Laboratories face a confusing menu of choices when they look to invest in CF screening reagents. By choosing the NGEN(TM) CFTR ASRs, labs can implement a simple solution for carrier screening that meets the standard of care,” noted Graham Lidgard, senior vice president of research and development at Nanogen. “By combining the recommended test with genetic counseling, laboratories and physicians will be able to deliver sound information to their patients.”
CF is one of the most common genetic disorders in Caucasian populations of European descent, carried by about 1 in 29 Caucasians. CF is characterized by pulmonary and gastrointestinal symptoms of varying severity, but most CF cases are associated with substantial illness and shortened lifespan and require lifelong medical care. CF is an autosomal recessive genetic disorder. To express the disease, a child must inherit two copies of the defective gene, one from each parent. Many people carry a single CF mutation and do not experience any significant health problems as a result. Couples who are both carriers have a one in four chance of having a child with CF.
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(R) electronic microarray platform and a line of reagents useful in rapid diagnostic tests. Nanogen’s ten years of pioneering research involving nanotechnology holds the promise of miniaturization and continues to be supported for its potential for diagnostic and biowarfare applications. For additional information please visit Nanogen’s website at 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 products under development can be successfully developed and commercialized, 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 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.
Nanogen, Inc.
CONTACT: Robert Saltmarsh, Chief Financial Officer of Nanogen, Inc.,+1-858-410-4600; or Pam Lord, Media & Investor Relations, Porter NovelliLife Sciences, +1-858-527-3494, plord@pnlifesciences.com, for Nanogen, Inc.
Web site: http://www.nanogen.com//
