Point-of-care testing (POCT) is contributing to the growth of the diagnostics product market. In the first six months of this year, the FDA approved 152 POC tests. InteLab estimates that POCT represented 35% of the in vitro diagnostics market in 2005 and that, by 2011, it will account for 41%. In 2005, the market for POCT products was worth nearly $10.5 billion. According to a FDA official, POCT manufacturers are increasingly interested in CLIA (Clinical Laboratory Improvement Amendments) wavers, as approximately 60% of labs that are CLIA certified are waived labs. In addition, FDA’s revised guidance for CLIA waivers released in January more directly addresses POCT. Source: Clinical Laboratory News

< | >