23andMe Improves BRCA Report For Communities Underrepresented In Genetic Testing

Building on our first FDA authorization for a direct-to-consumer genetic health risk test for cancer, 23andMe received clearance this week to expand the number of genetic test variants covered in our BRAC1/BRAC2 (Selected variants) Genetic Health Risk report.

These additional variants are all known to be associated with higher risk for breast, ovarian, prostate and pancreatic cancer. Adding these variants will increase the number of people who may benefit from the report.

The clearance allows 23andMe to include 41 more variants than the three already included in the BRCA1/BRCA2 (Selected Variants) Genetic Health Risk report. Those three variants are most common in people of Ashkenazi Jewish descent.

“23andMe is the first and only company with FDA clearance to provide information directly to consumers on genetic risk for cancer, without a prescription,” said Kathy Hobbs, 23andMe’s Chief Administrative officer. “This clearance also allows us to expand access to this important information to traditionally underserved populations.”

New Clearance

In total, the 44 genetic variants account for about 30-40 percent of cancer-related BRCA variants among people of African American, non-Ashkenazi European, and Hispanic/Latino descent, and also several variants found in people of East Asian and South Asian descent. Having any of these variants increases your cancer risk, regardless of your ancestry.

The new clearance also represents a continued commitment to pioneer this work with the FDA while expanding access to crucial genetic health information for people. 23andMe received the first FDA authorization for a direct-to-consumer genetic test in 2018. The latest clearance marks 23andMe’s fourth FDA clearance for hereditary cancer risk, and the ninth clearance for direct-to-consumer genetic health reports offered by 23andMe.

Beyond this most recent 510(k) clearance, the FDA also granted 23andMe the first-ever Predetermined Change Control Plan (PCCP). This will allow 23andMe to add more validated BRCA1/BRCA2 (Selected Variants) Genetic Health Risk report without additional premarket review if those variants meet the same rigorous analytical and clinical requirements demonstrated in the recent clearance. That decision is under a new regulatory policy adopted by FDA this spring focused on using artificial intelligence and machine learning-enabled software  for patient health.

“We are proud to continue pioneering a path for greater access to health information,” said Gibbs. “Becoming the first company to receive PCCP clearance from the FDA under this novel approach will enable us to increase the pace at which we improve and expand our BCRA report.”

Genetic Health Risk Report

New and existing 23andMe Health + Ancestry Service customers tested on our latest genotyping chip will have access to the expanded BRCA1/BRCA1 (Selected Variants) Genetic Health Risk report once it is updated. We plan to update this report with 41 additional variants 

this year. Customers who have not already opted in to their BRCA1/BRCA2 (Selected Variants) Genetic Health Risk report must opt in to receive the updated report. The report also includes an education module to ensure customers are fully informed on what they can learn from this report and how to use the results.

The 23andMe BCRA1/BCRA2 (Selected Variants Genetic Health Risk report utilizes the same informational concepts previously demonstrated in studies submitted to the FDA for its Genetic Health Risk reports. Those studies showed a 90 percent or greater overall user comprehensive in a demographically diverse population. 

23andMe also carried out robust analytical validation studies: Each variant tested demonstrated greater than 99 percent concordance with Sanger sequencing, and greater than 99 percent reproducibility when tested under different laboratory conditions. 

While the clearance expands the number of genetic variants covered in 23andMe’s BRCA1/BRCA2 (Selected Variants) Genetic Health Risk report, it does not test for all BRCA1 and BRCA2 variants known to increase cancer risk. Anyone with a family history of cancer should talk to their doctor to learn whether comprehensive genetic testing is right for them.

Related Articles On FamilyTree.com:

23andMe Published A New BRCA Study

Tricare Will Cover 5 New Genetic Diagnostic Tests

California Expands Consumer Protections For Genetic Testing

< Return To Blog