Nanogen Launches Cystic Fibrosis Analyte Specific Reagents
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Nanogen, Inc. has announced that 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.
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 CFTR ASR products are part of the company's growing NGEN™ brand of reagents for molecular applications.
The NGEN™ 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™ 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™ 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."