BioCentury
ARTICLE | Clinical News

LIPOchip regulatory update

December 19, 2011 8:00 AM UTC

The U.K.'s NICE issued final 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 The decision is in line with a July draft guidance (see BioCentury, Aug. 1). The committee said greater health benefits can be achieved cost-effectively through the use of comprehensive genetic analysis (CGA) to confirm an FH diagnosis, and noted targeting sequencing is less expensive and can be used for all relatives with no loss in health benefits. 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. ...