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FDA Watch: 23andMe Continues to Spearhead Direct-to-Consumer Marketing of LDT Genetic Tests

On March 6, the FDA announced its first ever approval of a direct-to-consumer breast cancer gene test—23andMe’s genetic health risk report for detecting BRCA1 and BRCA2 genetic mutations most commonly found in people of Ashkenazi Jewish descent. But in announcing the approval, the FDA also took pains to point out its "caveats." According to Donald St. Pierre, FDA acting director of the Office of In Vitro Diagnostics and Radiological Health:

  • The test should not be used as a substitute for seeing your doctor for cancer screenings or counseling on genetic and lifestyle factors that can affect cancer risk;
  • The test does not provide information on a person’s overall risk of developing any type of cancer;
  • Use of the test carries significant risks if individuals use the test results without consulting a physician or genetic counselor;
  • Test results should not be used to make treatment decisions such as prophylactic removal of breasts or ovaries.

A Blood Test Breakthrough
Still, the approval continues the FDA’s new liberal policies on DTC testing. Last April, the agency gave 23andMe the greenlight to engage in DTC marketing of its Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions.

And in December, the FDA proposed new rules allowing for DTC marketing of genetic tests without premarket approval in limited situations.

Other New FDA Approvals
Meanwhile, here’s a rundown of the other key new FDA approvals announced from late February through late March.

NEW FDA APPROVALS

Manufacturer(s) Product(s)
Longhorn Vaccines and Diagnostics De novo clearance of PrimeStore Molecular Transport Medium for stabilizing microbial nucleic acids
AESKU.Group 510(k) clearance of AESKUSLIDES nDNA lupis diagnostic test for use with firm’s Helios automated IFA system
Exalenz Bioscience 510(k) clearance of BreathID Hp point-of-care system and BreathID Hp Lab system for detecting H. pylori infection in adults extended to include detection of H. pylori infection in kids ages 3 to 17
Roche 510(k) clearance of Cobas m 511 hematology testing solution
Roche 510(k) clearance of Elecsys tumor-associated antigen immunological assay
23andMe Authorization for direct-to-consumer marketing of three BRCA1 and BRCA2 mutations commonly found in individuals of Ashkenazi Jewish descent
Oxford Immunotec Approval of tests screening whole blood and plasma for a tick-borne disease known as babesiosis
DiaSorin 510(k) clearance of received clearance of Liaison BRAHMS PCT II Gen assay for quantitative determination of procalcitonin in human serum and lithium heparin plasma specimens
Quidel 510(k) clearance of Sofia Lyme Fluorescent Immunoassay for detecting human IgM and IgG antibodies to Borrelia burgdorferi in serum or plasma samples
Alfa Scientific Designs 510(k) clearance and CLIA waiver of ALFA’s immunoassay fecal occult blood (iFOB) test with Driven FlowTechnology

During the period, the following FDA CLIA waivers were announced:

NEW FDA CLIA WAIVERS

Manufacturer(s) Product(s)
Alfa Scientific Designs ALFA’s iFOB with Driven Flow Technology

New CE Marks & Global Certifications
Notable European CE certifications:

NEW CE CERTIFICATIONS

Manufacturer(s) Product(s)
Agendia Approval of MammaPrint BluePrint, NGS kit for breast cancer recurrence risk testing and molecular subtyping
Saladax Biomedical Approval of MyCare Total Risperidone Assay Kit measuring total risperidone in patient’s blood
Saladax Biomedical Approval of MyCare Paliperidone Assay Kit measuring total paliperidone in patient’s blood
Qiagen Approval of Artus T. vaginalis QS-RGQ kit
Becton Dickinson Approval of PAXgene Blood ccfDNA tube

Other international clearances announced in the past month:

Manufacturer(s) Product(s) Product(s)
Thermo Fisher Scientific Canada Class III Medical Device System License to firm’s BRAHMS business for four automated immunofluorescent assays used as prenatal screening aids
Siemens Healthineers Canada Approval to market its Symbia Intevo Bold SPECT/CT system
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