Integrated Genetics' (IG) improved cystic fibrosis test canidentify 32 of the most common gene mutations found incarriers of cystic fibrosis.
The company announced the availability of the CF/32 CheekBrush test at the American Society of Human Genetics meetingin New Orleans on Wednesday. IG's original CF/16 Cheek Brushtest, introduced last year, can identify 16 mutations.
"Theoretically, the detection rate could be as high as 97.1percent, based on data collected by the Cystic Fibrosis GeneticAnalysis Consortium," the company said. It noted that its ownresearch data base yields a detection rate of 90.6 percent"based on a smaller sample size than the Consortium."
The testing procedure involves twirling brushes on each innercheek of the mouth for 30 seconds. Both brushes are sent to anIntegrated Genetics lab, which uses PCR (polymerase chainreaction) technology to amplify CFTR (cystic fibrosistransmembrane conductance regulator) gene segments in eachsample simultaneously for 32 mutations before analysis.
"The rapid method for simultaneous analysis of multiple pointmutations within the CFTR gene reduces the time necessary foramplification and analysis by 50 percent," the company said.This DNA-based test replaces the traditional method ofobtaining cells from a blood sample.
Cystic fibrosis is the "most common severe recessive geneticdisease in the Caucasian population, occurring in approximatelyone in 2,500 live births and affecting an estimated 30,000individuals in the U.S.," IG said. The carrier frequency of CFamong Caucasians in the U.S. is approximately one in 25.
IG's name until Sept. 20 was Integrated Genetics LaboratoriesInc. IG Labs and Vivigen Inc., which IG Labs manages forGenzyme Corp., now use the name Integrated Genetics. IG Labs,based in Framingham, Mass., remains the company's legal nameand its stock continues to be traded on the NASDAQ NationalMarket System under the symbol IGLI.
The company has been a majority-owned subsidiary ofGenzyme since 1989. IG's two operating subsidiaries, GeneticDesign (a paternity, identity and forensic testing laboratory inGreensboro, N.C.) and Integrated Oncology Laboratories ofChicago, will use their current names.
The genetic testing company has eight laboratories throughoutthe U.S. It does prenatal testing, cytogenetic testing,biochemical testing and fetal cell separation testing. In additionto cystic fibrosis, the company does DNA analysis for Duchennemuscular dystrophy, Huntington's disease, adult polycystickidney disease, sickle cell anemia, Factor VIII and Factor IXdeficiency, alpha thalassemia, beta thalassemia (anemia) andspinal muscular atrophy. IG plans to develop its Cheek Brushtest for use in these analyses as well.
The company's stock was up 75 cents a share on Wednesday,closing at $9.
-- Brenda Sandburg News Editor
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