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.
Maintenance treatment with Clovis' rucaparib may be a more tolerable maintenance therapy than chemo in platinum-responsive patients with mutations in BRCA1/2 or PALB2.
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.
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.
With retrospective and prospective analyses on women with BRCA1/2 mutations, investigators began teasing out breast cancer risk relative to reproductive history.
The agency said it is sensitive to stakeholder concerns and is working with MACs to adjust claims processing systems.
Healthcare providers continue to worry about the impact of 23andMe's health risk reports but there is also growing acceptance of the DTC testing model.
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.