23andMe gets FDA green light for cancer risk test

Dna testing powerhouse 23andMe announced today it&rsquos formally received the Food and drug administration go-ahead to produce an immediate-to-consumer testing package for genes associated with many forms of cancer. The forthcoming package, which is provided physician, tests for BRCA1 and BRCA2, that are associated with greater chance of ovarian, break and cancer of the prostate.

&ldquoBeing the foremost and only direct-to-consumer genetics company to get Food and drug administration authorization to check for cancer risk physician is really a major milestone for 23andMe but for the consumer,&rdquo the organization&rsquos Chief executive officer Anne Wojcicki stated inside a release associated with the announcement. &ldquoWe accept is as true&rsquos essential for customers to have direct and cost-effective use of this potentially existence-saving information. We'll continue pioneering a way for greater use of health information, and promoting a far more consumer-driven, preventative method of healthcare.&rdquo

Obviously, the exam shouldn&rsquot be used because the be all, finish all cancer risk &mdash neither is it meant like a substitute for any proper screening. As geneticist Eric Topol notes on The Verge, the 3 variants tested here only constitute a small % of countless known mutations. The exam can give a false feeling of safety among consumers.

Topol&rsquos warning reflects an FDA letter delivered to the service in 2013, advocating 23andMe to discontinue marketing its Saliva Collection Package and private Genome Service.

&ldquoSome from the ways to use which PGS is meant are particularly concerning,&rdquo the Food and drug administration writes, &ldquosuch as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) due to the potential health effects that may derive from false positive or false negative assessments for top-risk indications like these.&rdquo

The 3 variants from the gene are located most frequently in people of Ashkenazi Jewish descent, with one out of 40 people of this background transporting one. In females, the existence of among the variants increases cancer of the breast risk by as much as 85 % before age 70. Because the service notes, around 1 / 2 of BRCA carriers who offered health background inside a study don&rsquot report cancer history among immediate relatives.

Due to that, the service may potentially raise a warning sign and lead customers to obtain an additional screen. But, obviously, the outcomes from the test should by no means be used like a substitute for a vacation to the physician.

Find out more: https://techcrunch.com/2018/03/06/23andme-gets-fda-green-light-for-cancer-risk-test/