FDA Issues Report Citing Case Studies It Argues Supports Need for More Oversight of LDT

The FDA released a 30-plus page report detailing case studies it says demonstrate the need for the FDA to abandon its policy of enforcement discretion and exercise more robust oversight of laboratory developed tests (LDTs).  The FDA report, titled The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies is available on the FDA website. It categorizes the case studies according to the problems raised: false positives, false negatives, lack of relevance to the tested disease, tests linked to disproved scientific concepts, tests undermining drug approval or treatment selection, and un-validated tests. The cases were gathered, according to the FDA, from “publicly available information in medical journals, media reports and FDA Warning letters.”