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23andMe gets FDA Approval for Direct-To-Consumer Testing for Cancer

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Published on : Mar 07, 2018

For the first time, the U.S. Food and Drug Administration (FDA) has approved direct-to-consumer genetic test for gene mutation linked to various cancer types. 23andMe, a privately-held biotechnology company, announced on March 6, 2018 that it has secured a go-ahead for direct-to-consumer genetic testing kit for three mutations on the following genes: BRCA1 and BRCA2. The California-based personal genomics company can now sell these genetic tests to consumers without a prescription. Of note, mutations on these specific genes are linked to elevated risks for ovarian cancer, breast cancer, and prostate cancer. The variants of these genes are most popular in populations in Ashkenazi Jewish descent, albeit not the most common in worldwide populations.

The regulator categorically mentioned that the tests should not be considered as be-all end-all of identifying risks to all cancer types nor it should be seen as a viable substitute for seeking professional guidance, including seeing a doctor.

Test to Encourage Vulnerable Population to undergo BRCA Mutations Screening    

The testing is simple as one has just to collect their saliva and do a DNA testing with the home based kit. 23andMe considers the genetic test to be a breakthrough in preventive approaches to cancer. It opines that the direct-to-consumer kits will increase the accessibility to critical health information, In particular, the the test will be helpful to people with a family history of cancer or those linked to Ashkenazi Jewish ancestry, exhorting them to undergo BRCA mutations screening.

Tests come with Caveats 

Notwithstanding the direct accessibility and vast purported bene fits, the direct-to-consumer genetic testing kits have several caveats. The tests are said to have potential limitation to the extent the results can be misleading or a false sense of safety, contend skeptics. Numerous geneticists have argued that the three variants of BRCA/ BRCA2 make only a minor percentage of scores of important functional mutations linked to cancer. Without proper education, the results can be deemed insignificant in managing cancer, and certainly the kit can’t rule out disposition to a variety of other cancer types. However, 23andMe believes that the approval of one-of-its kind in oncology will espouse consumer-centered approaches to healthcare.