Home 5 Lab Industry Advisor 5 Laboratory Industry Report 5 FDA-lir 5 FDA Watch: Agency Offers a Modicum of Relief on DTC Marketing of Genetic Tests

FDA Watch: Agency Offers a Modicum of Relief on DTC Marketing of Genetic Tests

by | Jul 3, 2018 | FDA-lir, Industry Buzz-lir, Laboratory Industry Report

From - Laboratory Industry Report Last November, the FDA raised eyebrows with a notice for public comment proposing to make it easier to bring new… . . . read more

Last November, the FDA raised eyebrows with a notice for public comment proposing to make it easier to bring new genetic health risk (GHR) assessment tests to market. The message to GHR test manufacturers: Once you get first time premarketing authorization, you can sell new GHR tests directly to consumers (DTC) without undergoing additional review. Earlier this month, the agency finalized the proposal.

The New DTC Genetic Tests Exemption
The June 5 notice, (which also says that not even premarket notification is necessary for certain class II (moderate risk) GHR assessment devices) is the latest example of the FDA’s new “flexible” regulatory approach to genetic risk tests. “As consumer interest in genetic risk information grows, opportunities are also expanding for the detection of additional genetic conditions and diseases that can help inform people of their medical risks,” according to the statement.

While acknowledging that these tests pose risks “especially if they provide consumers with incorrect or misleading information that may be used to make health choices without the advice of a medical professional,” the agency insisted that one-time premarket authorization would be enough to manage the problems of false negatives and false positives. And, of course, test manufacturers would still be on the hook for making false claims in their DTC advertising.

Doesn’t Apply to GHR Tests Used for Treatment Decisions
The notice also makes it clear that the new exemption does not apply to GHR tests used to inform treatment decisions. The four types of tests that cannot be commercialized even with prior premarket approval include:

1. Prenatal testing;

2. Cancer predisposition testing;

3. Pharmacogenomics testing; and

4. Genetic diagnosis of deterministic autosomal dominant variants.

The not-for-treatment-decision limitations are consistent with previous FDA policy. Thus, for example, earlier this year, when the FDA granted first ever premarket authorization to 10 GHR tests from consumer genomics firm 23andMe, it attached strings in the form of “caveats” or controls restricting DTC marketing of GHR tests used to inform treatment decisions, such as hereditary cancer tests analyzing BRCA1 and BRCA2 genetic mutations that may influence women to decide whether to have a prophylactic mastectomy. (For more details, see NIR, April 3, 2018.)

New FDA Approvals
Here’s a rundown of the key new FDA approvals announced from mid-May through the third week in June:


AutoGenomicsBreakthrough device designation for Infiniti Neural Response Panel, genomic test measuring risk for opioid dependency, for physician use as an aid in prescribing pain medication
GrifolsClearance for Procleix Ultrio Elite, a combined screening test run on Grifols’ Procleix Panther system for HIV-1, hepatitis B, hepatitis C viruses and detection of HIV-2
GrifolsClearance for Procleix Panther nucleic acid test blood screening platform
Abbott LaboratoriesClearance for clinical chemistry magnesium assay used for quantitation of magnesium in human serum or plasma on Abbott’s Architect c8000 system
AlereClearance for Alere i Strep A 2 molecular test for qualitative detection of Streptococcus pyogenes or Group A Streptococcus bacterial nucleic acid in throat swab specimens
AlereClearance for Afinion HbA1c Dx used for measuring glycated hemoglobin or percentage of hemoglobin A1c in human venous and capillary whole blood
PerkinElmerClearance for C. luciliae immunofluorescence test (CLIFT) lupus diagnostics (already cleared in Europe)
Bühlmann LaboratoriesClearance for fCal ELISA assay to diagnose Crohn’s disease and ulcerative colitis
Gold Standard DiagnosticsClearance for Borrelia burgdorferi IgG/IgM ELISA assay for use as initial screen in the two-step testing process recommended by the US Centers for Disease Control and Prevention for detecting antibodies against B. burgdorferi bacteria
Agilent TechnologiesClearance for expanded use of Dako PD-L1 IHC 22C3 pharmDx assay as companion diagnostic test for Keytruda for cervical cancer
Fujirebio DiagnosticsClearance for expanded use of Lumipulse G BRAHMS PCT Assay for testing on Lumipulse G1200 immunoassay platform
(subsidiary of Sony)
Clearance for PanNAT microfluidic molecular diagnostics system and related test for Shiga toxin-producing Escherichia coli (STEC)
T2 BiosystemsClearance for T2Bacteria Panel to detect species of bacteria in whole blood samples from patients with potential bloodstream infections
Roche Ventana Medical SystemsClearance for Ventana CD30 (Ber-H2) assay for qualitative detection of CD30 protein in tissue stained with Ventana BenchMark Ultra instrument and OptiView DAB IHC Detection Kit
Sekisui MedicalClearance for chromogenic test that includes CP3000 Coagulation Analyzer, Coagpia AT Reagent, Coagpia Calibrator and Coagpia Control Set

During the period, the following FDA CLIA waiver was announced:


CepheidCLIA waiver for Xpert Xpress Strep A test to detect Group A Strep infection

New CE Marks & Global Certifications
Notable European CE certifications:


BioGxCE marking for six tests for various meningitis infections and antibiotic-resistant organisms designed to run on Becton Dickinson’s PCR-based BD Max platform
IncellDxCE marking for flow cytometry-based test for human papillomavirus

Other international clearances announced in the past month:

HologicCanadaHealthCanada approval of Panther Fusion system and assays for respiratory virus infections
Vela DiagnosticsChinaChina FDA approval of Sentosa SX, cell-free DNA kit
Genetic SignaturesAustraliaAustralian Therapeutic Goods Administration registration to sell Extended Spectrum Beta-Lactamase and Carbapenemase Producing Organisms Detection Kit for detecting antibiotic-resistant pathogens

Subscribe to view Essential

Start a Free Trial for immediate access to this article