ugg knightsbridge 23andMe Granted First FDA Authorization for Direct
Information contained on this page is provided by an independent third party content provider. Frankly and this Site make no warranties or representations in connection therewith. “We believe it important for consumers to have direct and affordable access to this potentially life saving information. We will continue pioneering a path for greater access to health information, and promoting a more consumer driven, preventative approach to health care.”23andMe will report on three variants in the BRCA1 and BRCA2 genes associated with a significantly higher risk of breast and ovarian cancer in women, and breast cancer in men. The variants may also be associated with an increased risk for certain other cancers. These variants are most prevalent in those of Ashkenazi Jewish descent, and have been observed at much lower rates in other ethnicities. About 1 in 40 individuals of Ashkenazi Jewish descent has one of these three variants. Women with one of these variants have a 45 85% chance of developing breast cancer by age 70. “But it important to understand that the majority of cancer is not hereditary, our test does not account for all genetic variants that can cause a higher risk of cancer, and people should continue with their recommended cancer screenings.”New and existing 23andMe Health + Ancestry Service customers that were genotyped on the company most recent platforms will have access to this report in the coming weeks. As with select other Genetic Health Risk reports, customers must specifically choose for themselves if and when they want to receive this information. The report also includes an education moduleto ensure customers are fully informed on what they can learn from this report and how to use the results.The 23andMe BRCA1/BRCA2 (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 which were shown to have 90% or greater overall user comprehension in a demographically diverse population study.Current clinical guidelines for genetic risk evaluation are based primarily on personal and/or family history of certain cancers. 23andMe has also observed that many of its customers for whom Ashkenazi Jewish ancestry was detected, did not self report any Jewish ancestry. These reports convey risk for diseases that may be passed to offspring.About 23andMe:23andMe, Inc. is the leading personal genetics company. Founded in 2006, the mission of the company is to help people access, understand and benefit from the human genome. The company was named one of MIT Tech Review “Smartest Companies” and one of Fortune “Brands that Matter.” 23andMe has more than five million customers worldwide, with over 80% consented to participate in research. 23andMe, Inc. is located in Mountain View, CA.The intended use of 23andMe BRCA1/BRCA2 (Selected Variants) Genetic Health Risk Report: Indications for Use: The 23andMe Personal Genome Service (PGS) uses qualitative genotyping to detect select clinically relevant variants in genomic DNA isolated from human saliva collected from individuals = 18 years with the Oragene Dx model OGD500.001 for the purpose of reporting and interpreting genetic health risks, including the 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants). 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 the BRCA1/BRCA2 variants in the general population. The test report does not describe a person overall risk of developing any type of cancer, and the absence of a variant tested does not rule out the presence of other variants that may be cancer related. This test is not a substitute for visits to a healthcare provider for recommended screenings or appropriate follow up and should not be used to determine any treatments.