FDA Watch: Agency Approves DTC Genetic Breast Cancer Test—But Attaches Strings

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.

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. (See NIR, April 26, 2017 for the details.) And in December, the FDA proposed new rules allowing for DTC marketing of genetic tests without premarket approval in limited situations. (See NIR, Dec. 11, 2017 for the details.)

2017 Record Year for Personalized Medicine Approvals
Another manifestation of the FDA’s liberalization is the16 new personalized medicine products the agency approved in 2017, 34% of all new of all new drugs, agents, or therapeutic biologics approved during the year. Key approvals included:

• Expanded approval of Keytruda to all tumor types, the first approval of an oncology drug based on a biomarker rather than location in the body;

• DTC marketing of 23andMe’s Personal Genome Service Genetic Health Risk tests noted above;

• Approval of personalized medicine biosimilar for Herceptin (trastuzumab); and

• Joint FDA approval and CMS coverage decision for Foundation Medicine’s NGS-based FoundationOne CDx test.

A Blood Test Breakthrough
On Valentine’s Day, the FDA announced another new milestone: the first agency approval of a blood test for use in diagnosing concussions. The Brain Trauma Indicator, marketed by Banyan Biomarkers Inc., measures two proteins associated with concussion when detected in high levels via CT scan. The new assay is blood-based and has been approved for use by physicians in ruling out concussion. Abbott is among the other firms reported to be developing their own blood test for detecting the proteins without CT scan.

Flu Tests
Meanwhile, as the U.S. struggled with its nastiest flu season in years, the FDA approved five different products for the qualitative detection of influenza in January and February, including:

• QuickVue Influenza A+B, an assay from Quidel that detects and differentiates between influenza types A and B in 10 minutes, which the agency reclassified as a class II rapid influenza diagnostic test;

• Two different rapid, instrument influenza detection and A vs. B differentiation tests from Alere, now part of Abbot;

• Xpert Xpress Flu, Cepheid’s new test system and molecular test for detecting A and B influenza from either nasopharyngeal or nasal swabs; and

• Mesa Biotech’s Accula Flu A/Flu B test which runs on the firm’s Accula system.