FDA is Seriously Concerned about Lab Developed Tests and Wants to Regulate Them Strictly

About three weeks ago, on 16th November 2014, FDA released an internal report highly critical of Lab Developed Tests (LDTs) using 20 such tests as examples. This report highlights several of FDA’s concerns regarding LDTs. According to this report, unregulated LDTs are dangerous to the public not only by giving false positive or negative results, but also claiming unproven ideas and financial loss to consumers. This report was also highlighted in a blog that day by FDA’s Associate Commissioner for Public Health Strategy and Analysis, Dr. Peter Laurie, indicating FDA’s assertion that regulation of LDTs is a major public health issue in the coming years. Both the report and the blog set the stage for FDA’s assertion that it is about time LDTs get regulated like other medical devices. It seems FDA is warming up for severe action against LDTs. FDA has always maintained that it has jurisdiction over all diagnostic tests as medical devices but till recently it used its “enforcement discretion” to allow LDTs to be marketed without requiring formal approval by FDA. Over the years, LDTs have flourished and the industry supplying such tests grew from a few small labs to a large industry that provides more than 11000 tests at 650 labs in the US. Practically, every consumer in the nation uses a few kinds of LDTs routinely, ranging from prenatal diagnostics for genetic defects to tests for practically all diseases and health conditions. The biggest milestone in FDA’s regulation of LDTs happened in 2010 when a genetic diagnostic company decided to go mainstream forcing FDA to a new reality where LDTs were not only commonly used but were going to be offered on a mass scale never before seen. FDA rapidly clamped down on almost all providers of genetic tests, most of which have still not been allowed. Since then FDA has been edging towards increased regulation of LDTs. In its announcement on 31 July 2014 FDA created new rules for LDTs by re-defining the differences between LDTs and traditional In Vitro Diagnostic (IVDs) tests, and by establishing processes to regulate all but a few diagnostic tests. Over the last 16 months, FDA released two guidance documents, one describing the new regulatory framework, and the other for medical adverse event reporting requirements for LDTs. FDA also held a public meeting to discuss the new rules for LDTs in January 2015, where more than 80 industry and public interest groups raised aired their opinions on FDA regulation of LDTs. Overall, the industry representatives were lukewarm to FDA proposals citing the stifling effect it may have innovation, availability of such tests to consumers, and cost of such tests. It seems now it is FDA’s turn to make its opinion heard. The new report cites 20 examples to show major concerns. These include lack of evidence supporting clinical validity, no independent and unbiased review of data, deficient adverse event reporting, unsupported claims, inadequate or misleading labeling, uneven playing field between LDTs and IVDs, and lack of scientific integrity of clinical trials where such tests are used. The tests FDA used for making its point include those of detecting Lyme disease, several cancer tests, tests for infectious diseases, diseases such as heart ailments and autism, and nutritional deficiency tests. FDA mentioned in the report that these tests represent well-documented cases from publicly available information in medical journals, media reports and FDA Warning Letters. It is also mentioned that FDA did review several other tests but could not include them in the report due to incomplete information or confidentiality rules. The report paints a derisive picture of LDTs. In 2014 alone, FDA issued 31 Warning Letters to LDT manufacturers and oversaw 313 recalls. It is clear where FDA is going from here. The draft guidance documents are expected to be finalized soon, and the enforcement timeline for the new rules will commence soon. We wonder if we will see another major announcement from FDA regarding regulation of LDTs, probably FDA is making true on its promise to drop the hammer on the LDT industry to increase review and accountability on such tests. Industry should have been ready by now; it had about 5 years lead time. Those caught unaware have only themselves to blame.