Orchid BioSciences Inc announced that the cystic fibrosis (CF) genetic testing kit, ELUCIGENE CF20, developed and marketed by its Cellmark Diagnostics subsidiary, has been successfully registered with the regulatory authorities in France for human in-vitro diagnostic use. The ELUCIGENE CF20 kit uses ARMS detection technology to simultaneously detect 20 common mutations of the CFTR gene that are associated with cystic fibrosis.

Before in-vitro diagnostic kits can be sold in France for diagnostic purposes, they must be registered with the Agence Francais de Securite Sanitaire des Produits de Sante (AFSSAPS) after undergoing rigorous clinical and analytical evaluation. The earlier ELUCIGENE CF12 kit developed by Cellmark Diagnostics was the first human DNA diagnostic test registered in France, and the ELUCIGENE CF20 kit is now the second. These kits have been developed and manufactured under internationally recognised quality systems accredited to ISO 9001, ISO13485 and EN46001.

"We are pleased that our ELUCIGENE CF20 kit is now available in France," said Christopher Ashton, Ph.D., vice president and managing director of Orchid BioSciences Europe, Ltd. "We have an established reputation for the quality and robustness of our diagnostic assays, and we are delighted that France is joining the many other countries where ELUCIGENE CF20 is already used."

The ELUCIGENE CF20 kit is not available in the United States, but Cellmark Diagnostics also manufactures and distributes an ELUCIGENE CF29 panel of Analyte Specific Reagents (ASRs) that covers all of the 25 mutations recommended by the American College of Medical Genetics (ACMG) for cystic fibrosis screening. Cellmark Diagnostics is also developing specific panels for cystic fibrosis screening of targeted populations in various other countries.

ELUCIGENE CF20 is available in 25 and 50 test kit sizes pre-dispensed in either 0.2ml or 0.5ml tube formats for simple and rapid cystic fibrosis analysis.