AHRQ lab-developed test assessment

Agency for Healthcare Research and Quality posts a final 1tech assessment on the "Quality, Regulation and Clinical Utility of Laboratory-developed Tests" on its website June 22. The report, largely unchanged from a draft document issued last August, was requested by CMS' Coverage and Analysis Group (2"The Gray Sheet" Aug. 24, 2009). The assessment concludes that establishing the quality of lab-developed tests is challenging and the lack of clinical validity or utility assessment is cause for concern. In particular, "given the dynamic nature of the molecular testing area, the assessments of the quality, regulation or utility of [lab-developed molecular tests] need to be frequently updated." FDA is seeking to finalize a comprehensive framework for oversight of lab-developed tests, with a public meeting on the matter scheduled for July 19-20 (3"The Gray Sheet" June 21, 2010)