BRCA2

23andMe Receives FDA Clearance for Direct-to-Consumer Genetic Test on a Hereditary Colorectal Cancer Syndrome

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星期二, 一月 22, 2019
Cancer, Branches of biology, Breast cancer, Health, Tumor markers, Tumor suppressor genes, Hereditary cancers, Oncology, Cancer syndrome, BRCA1, BRCA2, 23andMe

MOUNTAIN VIEW, Calif., Jan. 22, 2019 /PRNewswire/ -- 23andMe, Inc., the leading personal genetics company, today received FDA clearance for a genetic health risk report on a hereditary colorectal cancer syndrome.

Key Points: 
  • MOUNTAIN VIEW, Calif., Jan. 22, 2019 /PRNewswire/ -- 23andMe, Inc., the leading personal genetics company, today received FDA clearance for a genetic health risk report on a hereditary colorectal cancer syndrome.
  • The clearance follows the FDA's authorization for 23andMe's BRCA1/BRCA2 (Selected Variants) Genetic Health Risk report in March 2018.
  • The FDA included both this report and 23andMe's previously authorized BRCA1/BRCA2 (Selected Variants) Genetic Health Risk report in a single "Cancer Predisposition Risk Assessment System" regulation.
  • The FDA clearance for 23andMe's MUTYH-Associated Polyposis Genetic Health Risk report demonstrates substantial equivalence, through the FDA's 510(k) pathway, to its predicate device 23andMe's BRCA1/BRCA2 (Selected Variants) Genetic Health Risk report.

My Gene Counsel Expands Genetic Content One Month Into Launch

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星期二, 十一月 27, 2018
Medicine, Cancer, Breast cancer, Tumor markers, Tumor suppressor genes, Health, Medical genetics, Medical tests, BRCA2, BRCA1, Cancer syndrome, Genetic testing

"If you have had genetic testing using a hereditary cancer gene panel, we now have a report customized for your results," said Ellen Matloff, President and CEO of My Gene Counsel.

Key Points: 
  • "If you have had genetic testing using a hereditary cancer gene panel, we now have a report customized for your results," said Ellen Matloff, President and CEO of My Gene Counsel.
  • Previous My Gene Counsel reports only covered BRCA1 and BRCA2 content.
  • My Gene Counsel plans to expand its reporting to include cardiac, pharmacogenetic and many gene panels offered in the direct-to-consumer marketplace.
  • My Gene Counsel is a HIPAA-compliant digital resource for genetic information and a one-stop-shop to stay on top of advancements tied to personal genetic test results.

23andMe Granted the First and Only FDA Authorization For Direct-to-Consumer Pharmacogenetic Reports

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星期三, 十月 31, 2018
Genetics, Biology, Health, Breast cancer, Tumor markers, Tumor suppressor genes, Biological databases, 23andMe, Genetic testing, Anne Wojcicki, Food and Drug Administration, BRCA2

With this authorization, the FDA has classified these direct-to-consumer pharmacogenetic reports as moderate risk that have special controls to ensure safety, effectiveness and accuracy.

Key Points: 
  • With this authorization, the FDA has classified these direct-to-consumer pharmacogenetic reports as moderate risk that have special controls to ensure safety, effectiveness and accuracy.
  • This authorization enables 23andMe to report on numerous variants associated with pharmacogenetic response.
  • "We've continued to innovate through the FDA and pioneer safe, effective pathways for consumers to directly access genetic health information," said 23andMe co-founder and CEO Anne Wojcicki.
  • This latest FDA authorization follows several years of work by 23andMe that has led to four separate FDA de novo authorizations for direct-to-consumer genetic tests for carrier status, genetic health risk reports, select BRCA1 and BRCA2 variants and now pharmacogenetic reports.

2018 Global Strategic Business Report: Direct-to-Consumer (DTC) Genetic Testing - High Potential Benefits, But Concerns Persist

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星期四, 七月 12, 2018
Genetics, Biology, Breast cancer, Medicine, Tumor markers, Tumor suppressor genes, Medical genetics, Applied genetics, 23andMe, BRCA2, Genetic testing, BRCA

Quest Diagnostics and Inserm Launch BRCA Share, a Datashare Initiative with Open Access to BRCA1 and BRCA2 Genetic Data

Key Points: 

Quest Diagnostics and Inserm Launch BRCA Share, a Datashare Initiative with Open Access to BRCA1 and BRCA2 Genetic Data
23andMe Bags FDA Approval for Personal Genome Service, a DTC Genetic Test for Bloom Syndrome