LDTs: Top 10 New FDA Diagnostic Approvals of 2017

While the FDA remains glacial in its tempo, jealous of its authority and suspicious of the industry, it is also, ever so slowly, changing its ways. While the new administration’s dedication to cutting regulation is an obvious factor, the current thaw actually dates back to the previous administration. And it was on full display in 2017 as illustrated by not only the pace of new in vitro diagnostics approvals but types of products approved. Here’s our vote for the 10 most important approvals of 2017 (from a regulatory rather than strictly business perspective):   Manufacturer(s) Product(s) Comment 1 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases First time GHR tests approved for direct-to-consumer marketing—followed 7 months later by new FDA policy on DTC marketing of GHR tests 2 Memorial Sloan Kettering Cancer Center MSK-IMPACT NGS tumor profiling assay First comprehensive tumor-profiling LDT to receive FDA authorization through de novo premarket review pathway 3 Merck Keytruda (pembrolizumab) PD-1/PD-L1 inhibitor First approval of cancer drug administered on basis of genomic features of a tumor rather than where in patient’s body the tumor is 4 Thermo Fisher Scientific Oncomine Dx Target Test, NGS-based companion diagnostic for non-small cell lung […]