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FDA Accepts 510(k) Application for 23andMe Health Report on Bloom Syndrome

NEW YORK (GenomeWeb) –The US Food and Drug Administration has accepted for review 23andMe's 510(k) application for a single-condition health report, the consumer genomics firm informed customers.

"Although the submission focuses on a single rare but serious inherited condition we report to customers — Bloom syndrome — it is an important step in our work with the FDA in the coming months," Kathy Hibbs, 23andMe's chief legal and regulatory officer, wrote in a blog post.

The clearance of this report will help establish "the parameters for future submissions," Hibbs wrote, and provide a baseline level of accuracy that customers can expect to receive from the company.

For this application, 23andMe submitted validation data on its genotyping chip, software, and saliva kit. 23andMe has been using Illumina's HumanOmniExpress-24 format chip as of late last year.

With the acceptance of this first 510(k) submission, the FDA and 23andMe have essentially pressed the reset button on their protracted regulatory interactions surrounding the company's Personal Genome Service.

In November, the FDA asked 23andMe to stop marketing health-related genetic test results to customers through its Personal Genome Service until it received the agency's regulatory clearance or approval. After much public scrutiny, the Mountain View, Calif.-based firm complied with the agency's demands.

The company decided to maintain access to health-related reports for customers who received such data from the company or purchased a test kit before the FDA warning letter dated Nov. 22. Customers who purchased kits from the firm on or after Nov. 22 are only receiving ancestry-related information and their raw genetic data for the time being.

"While we are still in the very early stages of this regulatory review process, we remain committed to transparency and keeping our customers as informed as possible," Hibbs said in the post. "This by no means is the end of the process even for this one condition. It is likely that 23andMe will hear back from the FDA regarding the material we gave to them, and, we in turn will have to respond to those questions as we move forward."