HomeNews23andMe Improves BRCA Report For Communities Underrepresented In Genetic Testing |

23andMe Improves BRCA Report For Communities Underrepresented In Genetic Testing | Receive US

Constructing on our first FDA authorization for a direct-to-consumer genetic well being danger check for most cancers, 23andMe acquired clearance this week to increase the variety of genetic check variants coated in our BRAC1/BRAC2 (Chosen variants) Genetic Well being Danger report.

These extra variants are all recognized to be related to larger danger for breast, ovarian, prostate and pancreatic most cancers. Including these variants will improve the quantity of people that could profit from the report.

The clearance permits 23andMe to incorporate 41 extra variants than the three already included within the BRCA1/BRCA2 (Chosen Variants) Genetic Well being Danger report. These three variants are most typical in individuals of Ashkenazi Jewish descent.

“23andMe is the primary and solely firm with FDA clearance to offer info on to shoppers on genetic danger for most cancers, and not using a prescription,” mentioned Kathy Hobbs, 23andMe’s Chief Administrative officer. “This clearance additionally permits us to increase entry to this necessary info to historically underserved populations.”

New Clearance

In complete, the 44 genetic variants account for about 30-40 p.c of cancer-related BRCA variants amongst individuals of African American, non-Ashkenazi European, and Hispanic/Latino descent, and in addition a number of variants present in individuals of East Asian and South Asian descent. Having any of those variants will increase your most cancers danger, no matter your ancestry.

The brand new clearance additionally represents a continued dedication to pioneer this work with the FDA whereas increasing entry to essential genetic well being info for individuals. 23andMe acquired the primary FDA authorization for a direct-to-consumer genetic test in 2018. The most recent clearance marks 23andMe’s fourth FDA clearance for hereditary most cancers danger, and the ninth clearance for direct-to-consumer genetic well being experiences provided by 23andMe.

Past this most up-to-date 510(ok) clearance, the FDA additionally granted 23andMe the first-ever Predetermined Change Management Plan (PCCP). It will permit 23andMe so as to add extra validated BRCA1/BRCA2 (Chosen Variants) Genetic Well being Danger report with out extra premarket evaluation if these variants meet the identical rigorous analytical and medical necessities demonstrated within the current clearance. That call is beneath a brand new regulatory coverage adopted by FDA this spring targeted on utilizing artificial intelligence and machine learning-enabled software  for affected person well being.

“We’re proud to proceed pioneering a path for larger entry to well being info,” mentioned Gibbs. “Turning into the primary firm to obtain PCCP clearance from the FDA beneath this novel method will allow us to extend the tempo at which we enhance and increase our BCRA report.”

Genetic Well being Danger Report

New and current 23andMe Well being + Ancestry Service clients examined on our newest genotyping chip can have entry to the expanded BRCA1/BRCA1 (Chosen Variants) Genetic Well being Danger report as soon as it’s up to date. We plan to replace this report with 41 extra variants 

this yr. Prospects who haven’t already opted in to their BRCA1/BRCA2 (Chosen Variants) Genetic Well being Danger report should decide in to obtain the up to date report. The report additionally contains an schooling module to make sure clients are absolutely knowledgeable on what they’ll study from this report and find out how to use the outcomes.

The 23andMe BCRA1/BCRA2 (Chosen Variants Genetic Well being Danger report makes use of the identical informational ideas beforehand demonstrated in research submitted to the FDA for its Genetic Well being Danger experiences. These research confirmed a 90 p.c or larger total consumer complete in a demographically various inhabitants. 

23andMe additionally carried out strong analytical validation research: Every variant examined demonstrated larger than 99 p.c concordance with Sanger sequencing, and larger than 99 p.c reproducibility when examined beneath totally different laboratory circumstances. 

Whereas the clearance expands the variety of genetic variants coated in 23andMe’s BRCA1/BRCA2 (Chosen Variants) Genetic Well being Danger report, it doesn’t check for all BRCA1 and BRCA2 variants recognized to extend most cancers danger. Anybody with a household historical past of most cancers ought to speak to their physician to study whether or not complete genetic testing is correct for them.

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