April 4, 2018, at 12 pm PT/3 pm ET
23andMe’s New FDA-Authorized BRCA1/BRCA2 (Selected Variants)* Report
Last month, 23andMe was granted the first FDA authorization for a direct-to-consumer Genetic Health Risk report for three variants in the BRCA breast cancer genes.*
Listen to our webinar to learn about the science behind our test, what FDA authorization means and how genetic risk information is communicated to consumers. We provide a walkthrough of the consumer experience and answer questions that were submitted during a live Q&A session.
This webinar is intended for healthcare professionals.
Carrier Screening decision summary: https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN140044.pdf
Carrier Screening exemption rule: https://www.gpo.gov/fdsys/pkg/FR-2017-11-07/pdf/2017-24162.pdf
Genetic Health Risk decision summary: https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN160026.pdf
BRCA1/BRCA2 announcement: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm599560.htm (decision summary not yet available)
Shirley Wu, PhD, leads the team of PhD scientists responsible for researching, critically evaluating, and writing 23andMe’s health reports. She received her B.S. in Computational Biology from Brown University and her PhD in Biomedical Informatics from Stanford University working with Dr. Russ Altman. Shirley joined 23andMe in 2009 as a Curation Scientist and took on roles at the intersection of product development, scientific critique, regulatory affairs, quality assurance, and science communication. Serving as head of 23andMe’s scientific product team since 2010, Shirley is committed to maintaining rigorous scientific standards, making an accessible and compassionate product experience, and providing information that engages individuals towards better health and wellness.
Stacey Detweiler, MS, LCGC, is a licensed and board certified genetic counselor with 4 years of clinical and research experience in perinatal genetics. She is also an active member of the National Society of Genetic Counselors. Stacey joined 23andMe in 2016 as a Medical Affairs Associate and focused on product, clinical, and educational development. In her previous roles, Stacey served as both a perinatal genetic counselor and clinical research coordinator at Rutgers-Robert Wood Johnson Medical School. She also continued her work as a perinatal genetic counselor providing direct patient care at Palo Alto Medical Foundation.
*The 23andMe PGS test uses qualitative genotyping to detect clinically relevant variants in the genomic DNA of adults from saliva for the purpose of reporting and interpreting genetic health risks and reporting carrier status. The relevance of each report varies based on ethnicity. Each genetic health risk report describes if a person has variants associated with a higher risk of developing a disease, but does not describe a person’s overall risk of developing the disease. Our carrier status reports can be used to determine carrier status, but cannot determine if an individual has two copies of any genetic variant. These carrier reports are not intended to tell an individual anything about risk for developing a disease in the future or anything about the health of a fetus, or newborn child’s risk of developing a particular disease later in life. For certain conditions, we provide a single report that includes information on both carrier status and genetic health risk. These reports are intended to provide genetic information that can be used to inform lifestyle decisions and conversations with healthcare professionals, but are not intended to diagnose disease, determine medical treatment or medical intervention including whether to take a medication or how much of a medication to take, or tell the user anything about their current state of health. Any diagnostic or treatment decisions must be based on confirmatory prescription testing and/or other information that you determine to be appropriate for your patient, such as additional clinical testing and other risk factors that may affect individual risk and health care. Warnings & Limitations: The 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) is indicated for reporting of the 185delAG and 5382insC variants in the BRCA1 gene and the 6174delT variant in the BRCA2 gene. The report describes if a woman is at increased risk of developing breast and ovarian cancer, and if a man is at increased risk of developing breast cancer or may be at increased risk of developing prostate cancer. The three variants included in this report are most common in people of Ashkenazi Jewish descent and do not represent the majority of BRCA1/BRCA2 variants in the general population. This report does not include variants in other genes linked to hereditary cancers and the absence of variants included in this report does not rule out the presence of other genetic variants that may impact cancer risk. The PGS test is not a substitute for visits to a healthcare professional for recommended screenings or appropriate follow-up. Results should be confirmed in a clinical setting before taking any medical action.
For important information and limitations regarding other genetic health risk reports and carrier status reports, visit https://www.23andme.com/test-info/.