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FDA Watch: New Policy Would Allow DTC Marketing of Genetic Tests without Premarket Approval

by | Dec 4, 2017 | Essential, FDA-lir, Industry Buzz-lir, Laboratory Industry Report

From - Laboratory Industry Report For years, the lab industry has been pressing the FDA to relinquish its rigorous oversight of direct-to-consumer (DTC) genetic health tests… . . . read more

For years, the lab industry has been pressing the FDA to relinquish its rigorous oversight of direct-to-consumer (DTC) genetic health tests. On Nov. 6, the agency finally made a move in that direction proposing to allow precertified manufacturers to bring genetic tests to market without undergoing premarket review.

The present policy dates back to the 2013 warning letter the FDA issued to 23andMe ordering the consumer genomics firm to stop marketing its DNA analysis services. Since then, newfangled DTC genetic tests have required premarket approval.

But even before the Trump administration, the FDA has been seeking to modernize its approach to allow room for innovation. According to the agency’s notice for public comment, is not necessary for certain class II (moderate risk) devices, including vitamin D mass spectrometry-based test systems and genetic health risk (GHR) assessment test systems. The catch: GHR test manufacturers will need first time FDA marketing authorization; after that, though, they will be allowed to commercialize new GHR tests without additional review.

Earlier this year, foreshadowed the new policy in its premarket authorization of 10 GHR tests from 23andMe giving the greenlight for DTC launches of other tests without premarket review provided that it followed listed controls, which include the requirement that 23andMe publish:

  • Labeling outlining test limitations;
  • Information about how the test works and its accuracy vis-à-vis a comparative baseline;
  • References to applicable clinical guidelines and disease risks; and
  • Information on obtaining a genetic counselor.

The Nov. 6 notice, which at this point is a proposal rather than a formal policy, essentially extends the 23andMe approach to all GHR test makers. There’s also a limitation: The new approach doesn’t apply to diagnostic genetic tests that inform treatment decisions, e.g., hereditary cancer tests analyzing BRCA1 and BRCA2 genes to decide if a woman should have a prophylactic mastectomy.

And for now at least, the FDA is maintaining the hard line on DTC companies issuing warning letters to DNA4Life and Interleukin Genetics for marketing tests without premarket approval.

New FDA Approvals

Meanwhile, here’s a rundown of key new approvals issued by the FDA in late October through November:


Manufacturer(s) Product(s)
Clinical Genomics +
Quest Diagnostics
Approval of InSure One fecal immunochemical test to detect blood in stool
Memorial Sloan Kettering Cancer Center Approval of MSK-IMPACT NGS tumor profiling assay
Abbott Approval of Alinity c clinical chemistry system
Abbott Approval of Alinity i immunoassay system
Roche Approval of Ventana MMR IHC panel for colorectal cancer patients
Roche Approval of Ventana ALK (D5F3) companion diagnostic to  identify ALK-positive non-small cell lung cancer patients who would benefit from treatment with firm’s Alecensa (alectinib) drug
Luminex Approval of Aries Group A Strep Assay
Hardy Diagnostics Approval of Delafloxacin Antimicrobial Susceptibility Disk tests to guide MDs in use of Melinta Therapeutics bacterial skin and skin structure infections treatment drug
Thermo Fisher Scientific Approval of Sensititre MIC System for assessing patients who may be appropriate for Melinta Therapeutics’ Baxdela treatment
Hologic Approval of Panther Fusion Paraflu multiplexed assay for running on Panther Fusion system
Quidel Approval of Solana RSV + hMPV assay to detect viral RNA from nasal and nasopharyngeal swabs run on firm’s Solana molecular testing instrument
Quidel Approval of Sofia Lyme FIA Lyme disease test on Quidel Sofia platform
Myriad Genetics Supplementary premarket approval application of BRACAnalysis CDx to identify metastatic breast cancer patients likely to respond to AstraZeneca’s Lynparza (olaparib) drug
Instrumentation Laboratory Approval of HemosIL AcuStar HIT-IgG(PF4-H) assay

In November, the FDA granted CLIA waivers to the following test kits:


Manufacturer(s) Product(s)
Alere Alere Technologies AS, Afinion 2 analyzer
Bayer Healthcare Polymer Technology Systems, Inc., CVS Health At Home A1C Test Kit
Bayer Healthcare Polymer Technology Systems, Inc., ReliOn Fast A1C Test At-Home A1C System
Bayer Healthcare Walgreens, Co., Walgreens At Home A1C Test Kit

New CE Marks & Global Certifications

Notable European CE certifications:


Manufacturer(s) Product(s)
Molzym Approval of Micro-Dx microbial DNA isolation and direct PCR test for routine pathogen diagnosis
Beckman Coulter Approval of Access hsTnI high-sensitivity troponin assay
SpeeDx Approval of PlexPCR VHS multiplex qPCR test
Mindray Approval of HIV and HBV test kits for HBsAg, Anti-HBs, Anti-HBc, HBeAg and Anti-HBe

Other new international approvals included:

  • China FDA approval of TBG Biotechnology HLAssure SE SBT portfolio of high-resolution human leukocyte antigen genotyping kits for hematopoietic cell transplantation;
  • China FDA approval of Ortho Clinical Diagnostics’ Ortho Vision platform; and
  • Singapore Health Sciences Authority approval of Vela Diagnostics’ Sentosa SQ HIV Genotyping Assay.

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