Win for personal genetics: FDA approves first in-home breast cancer DNA test

March 7, 2018 By Mehdi Maghsoodnia posted on Medium.com

Today is a fantastic day for the DNA testing industry.

In an unprecedented move the Food and Drug Administration has approved 23andme’s first direct-to-consumer breast cancer test, screening for three BRCA variants. It is without a doubt a true milestone in consumer health empowerment.

Often when a regulatory body gets involved in an industry, innovation can suffer. But this is not what happened today. The FDA’s move sets the stage for the transformation of healthcare towards a more consumer-centric model.

Direct-to-consumer DNA testing stands behind a hot new trend that will revolutionize how we perceive and experience healthcare in the United States and globally. As we are entering an age of affordable and accessible medical testing (from DNA to microbiome to blood and beyond), consumers will have more personal health data enabling them to become their own health advocates.

Naysayers will argue that people need intermediaries – medical professionals that translate information for patients and help them navigate through their healthcare options. I strongly believe that consumers are prepared to understand and use information about their health when it is provided in a clear and transparent way. A perfect example of a patient advocating for her own health is Angelina Jolie who after testing positive for a BRCA mutation made a personal decision to have a double mastectomy which she detailed in her op-ed piece in The New York TImes. The mutations of BRCA genes are known to dramatically increase the risk of developing breast cancer and ovarian cancer for women.

As 23andme CEO Anne Wojcicki has pointed out in her blog post today, finding out about being a carrier of BRCA didn’t induce anxiety in those who got tested, which was the concern of many. Instead, the results of DNA testing for BRCA sparked crucial conversations.

The new offering by 23andme, which we champion, focuses on disease detection and prevention. Making this happen is what, by her own admission, caused Ms. Wojcicki many sleepless nights.

What keeps me up at night however is the fact that most dollars in the healthcare system in the US and globally are spent on disease detection and management instead of prevention and wellness. Our challenge as a society is to educate people early on about behaviors that help them live a happier and healthier lifestyle.

Vitagene mission is to focus on this challenge. By looking holistically at the combination of DNA, lifestyle, medical history and family ancestry, we are trying to partner with the consumer to better advise them on their optimal diet, nutrition, exercise and lifestyle choices. We believe we can change the conversation in healthcare to one of prevention and wellness.

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