LIPOchip regulatory update

The U.K.'s NICE issued draft guidance recommending against the use of the genetic tests Elucigene FH20 from Gen-Probe Inc. (NASDAQ:GPRO, San Diego, Calif.) and LIPOchip from Progenika Biopharma to confirm a clinical diagnosis of familial hypercholesterolemia ( FH), or for the screening of relatives for FH. The committee said Elucigene FH20 and LIPOchip are not as clinically and cost-effective as DNA testing using comprehensive genetic analysis (CGA) for an individual. NICE also said the tests are not as clinically and cost-effective as targeted DNA testing for screening of relatives. NICE said Elucigene FH20 and LIPOchip detect only a subset of mutations associated with FH, while CGA testing detects almost all mutations. NICE said Elucigene FH20 and LIPOchip detect only a subset of mutations associated with FH, while CGA testing detects almost all mutations. In 2008, NICE recommended CGA DNA testing in its clinical guidelines on the identification and management of FH. Comments are due by Aug. 23. Final guidance is expected in December. ...