NEW YORK, Aug 16 – Orchid BioSciences said Thursday it had received approval to provide its cystic fibrosis genetic screening test to certain approved labs in the United States.
The Elucigene CF 29 test screens for 29 common mutations associated with cystic fibrosis and includes the 25 mutations the American College of Medical Genetics recommends for cystic fibrosis testing.
The Elucigene test uses allele specific amplification, a modified version of the polymerase chain reaction, to detect mutations.
For the past decade Europe has been using Elucigene kits and reagents to test for mutations.
This will be Orchid’s first genetic diagnostic launched in the US. Orchid of Princeton, NJ, recently said that this European subsidiary had registered its Elucigene CF20 kit in France for human in-vitro diagnostic use.