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23andMe Has Accelerated The Consumer Genomics Debate

This article was originally published in Start Up

Executive Summary

23andMe’s battle with FDA is another reminder that genomics is rapidly becoming incorporated not only into the clinic, but also into everyday life. It is forcing FDA and other agencies to take a stand on critical technical, legal, and ethical issues, which will influence the strategies of medical diagnostics and pharmaceutical companies as well as labs performing tests directly for the consumer.

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23andMe Opens Up FDA Pathway For DTC Genetic Predisposition Tests

23andMe has made it full circle with at least 10 direct-to-consumer genetic predisposition tests gaining FDA go-ahead for testing services to provide information on an individual's risk for developing Alzheimer's, Parkinson's, and celiac disease, among others. The de novo classification comes three-and-half years after the firm's DTC genetic testing service was forced off the market by FDA, and two years after it was able to relaunch carrier-screening test services.

FDA Comes Down Hard On 23andMe, Putting Consumer-Directed Genetic Testing On Notice

The agency tells direct-to-consumer genetic testing company 23andMe in a strongly-worded warning letter that it should immediately stop marketing its Personal Genome Service until it can gain clearance. The firm says it will address the agency’s concerns.

FDA Approves First Next-Generation DNA Sequencing Platforms

Illumina’s MiSeqDx instrument and MiSeqDx Universal Kit, granted de novo approval, allow clinicians to “develop and validate sequencing of any part of a patient’s genome,” FDA says.

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