FDA found the company as being in violation of the Federal Food, Drug and Cosmetic Act (FD&C Act), by marketing a medical device subject to FDA oversight without marketing clearance or approval. The PGS kit is intended to identify a reported 240+ health conditions and traits, such as carrier status, health risk for a number of chronic conditions based on genetic status, and markers predictive of drug response.

This is a significant regulatory action taken by FDA regarding genetic tests, and also represents a stand taken on the regulation of laboratory developed tests (LDTs). FDA sent out their warning letter the same week they cleared the first high-throughput next-generation DNA sequencer, Illumina’s MiSeqDX, a nondisease specific platform for validation of any part of genome. While this is an indication that FDA is starting to embrace a new way of thinking about the approaches they use for clearance/approval of innovative medical products, they have followed that up with clear lines of demarcation. At the annual American Society of Clinical Oncology meeting early this year, Margaret Hamburg indicated that FDA was actively considering regulating LDTs, and working to develop risk-based guidance.

In the warning letter, FDA expressed specific concerns over claims made by 23andMe, Inc., regarding BRCA-related genetic risk for cancer and predictive markers for drug responses. FDA claimed that the risks posed to the users by the tests are far too great, exposing them to potentially unnecessary and dangerous medical interventions. Tests with such claims are deemed Class III – the highest risk for a device – and require robust clinical validation using rigorous standards needed for FDA approval.

This was followed by the final issuance of a guidance on ‘Research Use Only Diagnostic devices’ on Monday. All of these steps seem like preparatory steps and would indicate that FDA is laying the groundwork to issue guidance on LDTs next, Avalere Health experts say.

Read FDA’s letter.