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MDx/CDx Focus: 23andMe Still Working with FDA; Aetna Lists Medically Necessary, Investigational Dx


While Working with FDA, 23andMe Offers Customers No Timeline for Reporting Health-related Results

Consumer-focused genetic testing firm 23andMe is working with the US Food and Drug Administration to meet regulatory requirements so that it can return certain health-related reports to its customers. However, in a recent update to customers, the company was unable to provide a timeline for when this might occur.

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 nod. 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.

Resolving its regulatory issues with the FDA is 23andMe's main priority, according to the company, but "despite 23andMe’s intense attention on this regulatory process, navigating it will take time." As such, new customers who purchased a test from 23andMe on or after Nov. 22 still can't get health-related genetic test results, and the firm told potential new customers to take this into account before purchasing a test.

"We do not yet have a timeline for when [health-related results] may be available," the company told customers. "We are doing everything we can to work through this process and return to providing all 23andMe customers access to genetic health information."

The company went on to say that 23andMe executives and scientists have met with FDA officials several times since receiving the warning letter in November, but didn't elaborate further.

Aetna Policy Bulletin Lists Medically Necessary, Investigational Tests

In a March 21 policy bulletin, Aetna provided a list of tumor markers which it deems medically necessary to test for, and a number of diagnostics it considers experimental or investigational.

Among the list of medically necessary markers, Aetna lists KRAS mutation analysis with BRAF reflex testing to identify colorectal cancer patients who are non-responders to Erbitux (cetuximab) and Vectibix (panitumumab). Other tests in this category include those that gauge BRAFV600E mutations to identify best responders to melanoma drugs Zelboraf (vemurafenib), Mekinist (trametinib), and Tafinlar (dabrafenib); PGx testing for ROS1 and ALK translocations to gauge non-small cell lung cancer patients who will respond to Xalkori (crizotinib); and Genomic Health's Oncotype DX breast cancer recurrence test.

The list of investigational tests, includes BRAF mutation testing for lung and thyroid cancer; Agendia's MammaPrint breast cancer recurrence tests; Vermillion's OVA1 test; and Caris Life Science's Target Now molecular profiling service; to name a few. Aetna also listed a number of next-generation sequencing based panel tests as investigational, such as Foundation Medicine's FoundationOne and FoundationOne Heme, and Ambry Genetics' BreastNext and CancerNext tests for hereditary cancers.

"The peer reviewed medical literature does not support these tests as having sufficient sensitivity or specificity necessary to define their clinical role," Aetna said. In the bulletin, the insurer also discusses the underlying evidence that informed its of its policy position regarding these tests.

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