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LDTs: Top 10 New FDA Diagnostic Approvals of 2017

by | Jan 17, 2018 | Essential, FDA-nir, National Lab Reporter, News-nir

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 […]

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
123andMePersonal Genome Service Genetic Health Risk (GHR) tests for 10 diseasesFirst time GHR tests approved for direct-to-consumer marketing—followed 7 months later by new FDA policy on DTC marketing of GHR tests
2Memorial Sloan Kettering Cancer CenterMSK-IMPACT NGS tumor profiling assayFirst comprehensive tumor-profiling LDT to receive FDA authorization through de novo premarket review pathway
3MerckKeytruda (pembrolizumab) PD-1/PD-L1 inhibitorFirst approval of cancer drug administered on basis of genomic features of a tumor rather than where in patient's body the tumor is
4Thermo Fisher ScientificOncomine Dx Target Test, NGS-based companion diagnostic for non-small cell lung cancer for detecting multiple gene mutations (BRAF, ROS1, and EGFR) from single tissue specimenFirst NGS oncology panel approved for multiple therapies
5Illumina + AmgenExtended RAS Panel, companion diagnostic run on Illumina's MiSeqDx system to analyze variants in KRAS and NRAS genes to determine if patients will benefit from Amgen's Vectibix (panitumumab)Only third NGS-based companion diagnostic approved by FDA in oncology
6Foundation OneFF1CDx companion diagnostic for solid tumorsSimultaneously approved by CMS for Medicare coverage under new Parallel Review Program
7Roche DiagnosticsCobas test for detecting Zika virus in plasma specimens of human blood and organ donorsFirst Zika detection test approved for use by blood collection facilities in screening blood supplies
8Royal PhillipsIntelliSite Pathology SolutionFirst US approval of digital pathology solution for primary diagnostic use by pathology labs
9

Accelerate Diagnostics Inc.

PhenoTest BC KitFirst approval of test identifying organisms causing bloodstream infections and antibiotics to which organism is likely to respond
10Lia DiagnosticsLia Pregnancy TestFirst FDA-cleared, flushable, biodegradable pregnancy test, according to the company

Disagree with Our Choices?
Let us know which new FDA diagnostic approvals of 2017 you considered to be the most significant. (glennsdemby@gmail.com)

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