23andMe gets clearance for testing of cancer gene

Clearance follows FDA approval for breast cancer genetic health risk report


Earlier this year, the genetics company 23andMe got what could be life-changing news for people everywhere: The Food and Drug Administration cleared the company for a new genetic health risk report on a hereditary cancer.

The company will soon be able to test people's risk for colorectal cancer syndrome -- a hereditary disease that can affect men and women. Children of people who carry the genes have a 50% chance of inheriting the disease-causing gene, according to WebMD.

The clearance followed a 2018 FDA authorization for the company's BRCA1/BRCA2 genetic health risk report.

BRCA1 and BRCA2 are the best-known genes linked to breast cancer. Sound familiar? You may remember Angelina Jolie announcing in 2013 that she'd had a preventative double mastectomy. She opted for the surgery after learning she carried the BRCA1 gene and that she had an 87 percent chance of contracting breast cancer.

23andMe, which was named by Time magazine a "genius company" last year, said the two cancer tests it offers are the only direct-to-consumer genetic health risk tests for inherited cancers that have been cleared by the FDA for use without prescription.

This latest clearance follows years of work that has led to several FDA authorizations for direct-to-consumer genetic tests for carrier status, genetic health risk reports, BRCA1/BRCA2 variants and genetic differences in people's responses to drugs. They have each included evidence demonstrating that the reports are scientifically valid, understandable and reliable.

"We are committed to giving people affordable and direct access to important health information that can impact their lives," said Anne Wojcicki, 23andMe CEO and co-founder. "We believe improved access to genetic testing and health information will help people engage in their own health."

The company said the report on hereditary colorectal cancer syndrome is not available quite yet, but when it is, the test will be offered to new 23andMe users, as well as existing ones who have already been genotyped. This and the BRCA1/BRCA2 health risk will be available in a single "Cancer Predisposition Risk Assessment System."

It's worth noting that in order to have access to the test, you must use the 23andMe Health + Ancestry Service. The health portion tests for genetic risks of all kinds of hereditary diseases and conditions, including celiac disease, late-onset Alzheimer's disease, Parkinson's disease, cystic fibrosis,
lung and liver disease, gluten-related autoimmune disorder and blood clots, among others.

As with previous tests, customers must choose whether they want to receive the information. It will also include education module to ensure customers understand how to interpret the results.

If you're unaware of how 23andMe works, it's quite simple:

1. The company mails a package that includes a home-based saliva collection kit. It usually arrives within three to five days.
2. Follow the directions to spit in the tube provided and register your saliva tube by using a barcode designated just to you before mailing it back in a prepaid package.
3. In about six to eight weeks, you'll receive an email that your reports are ready to view by signing into your account.

Is this genetic testing too invasive, or could it be the next big leap in getting ahead of cancer -- a sneak peak into our future, possibly?

"I think someday knowing your own genetics is just going to be part of your daily life, just the way that now, people know about their cholesterol levels or their blood pressure," said Joyce Tung, 23andMe's director of research. "Genetics is just one of those things that's going to be tied to all of us, and we're gonna use it to help us make certain decisions or make certain choices in our lives."