By Kelly A. Briganti, Editorial Director, G2 Intelligence
The U.S. Food and Drug Administration (FDA) released a 30-plus page report yesterday 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).
An FDA Voice blog article announcing the release of the report describes the report as an illustration of “the real and potential harms to patients and to the public health from certain laboratory developed test (LDTs).” The report covers 20 case studies that the FDA asserts demonstrate the risks of false positives and false negatives and other issues relating to certain LDTs. FDA Voice blog author, Peter Lurie M.D., M.P.H., FDA’s Associate Commissioner for Public Health Strategy and Analysis claims the lack of FDA oversight of LDTs has led to “staggering” costs and indicates the report estimates the “public health cost for five of the 20 cited tests.”
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 unvalidated tests. The cases were gathered, according to the FDA, from “publicly available information in medical journals, media reports and FDA Warning letters.”