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LDTs: Top 10 New FDA Diagnostic Approvals of 2017

by | Jan 9, 2018 | Essential, FDA-lir, Industry Buzz-lir, Laboratory Industry Report

From - Laboratory Industry Report The phrase "most exciting FDA laboratory developed test approvals of the year" is no longer an oxymoron. The agency remains glacial in tempo… . . . read more

The phrase “most exciting FDA laboratory developed test approvals of the year” is no longer an oxymoron. The agency remains glacial in tempo, jealous of its authority and suspicious of the industry it oversees. But it is also keenly aware of its reputation as a bar to medical progress and slowly, ever so slowly, looking to change its ways. While the current regulatory environment provides an obvious stimulus, the thaw of the FDA actually dates back to the previous administration. And it’s manifested in not only the pace of new in vitro diagnostics approvals but the kinds of products that are being 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 cancer for detecting multiple gene mutations (BRAF, ROS1, and EGFR) from single tissue specimen First NGS oncology panel approved for multiple therapies
5 Illumina + Amgen Extended 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
6 Foundation One FF1CDx companion diagnostic for solid tumors Simultaneously approved by CMS for Medicare coverage under new Parallel Review Program
7 Roche Diagnostics Cobas test for detecting Zika virus in plasma specimens of human blood and organ donors First Zika detection test approved for use by blood collection facilities in screening blood supplies
8 Royal Phillips IntelliSite Pathology Solution First US approval of digital pathology solution for primary diagnostic use by pathology labs

Accelerate Diagnostics Inc.

PhenoTest BC Kit First approval of test identifying organisms causing bloodstream infections and antibiotics to which organism is likely to respond
10 Lia Diagnostics Lia Pregnancy Test First 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. (glenn@plainlanguagemedia.com).

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