In 125,000 de-identified Invitae customers with and without a personal or family history of cancer, 23andMe's DTC test would have missed almost 90 percent of BRCA mutations.
The test will be used to identify men with metastatic, castrate-resistant prostate cancer and germline BRCA mutations who are enrolled in a study for olaparib.
CMS had received significant stakeholder feedback that germline NGS testing is not the same as somatic testing, and that the NCD as written would negatively impact patients.
My Gene Counsel's confirmatory testing program is the latest example of how the healthcare system is adapting to consumers' growing appetite for genetic testing.
By focusing too heavily on family history, the Preventive Services Task Force is missing many opportunities for prevention, patient advocates, industry players, and researchers say.
The agency said it is sensitive to stakeholder concerns and is working with MACs to adjust claims processing systems.
The kit is approved for the qualitative detection of BRCA1 and BRCA2 mutations in patients with different cancer types including breast cancer.
The American Society of Breast Surgeons updated consensus guidelines to recommend multigene panel testing for patients with cancer, including those who were tested many years ago.
The diversity of the organizations that have signed the letter to CMS demonstrates widespread concern over this policy.
The latest guidelines include new language about screening individuals with BRCA mutations and the potential utility of certain biomarker tests.