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News and reporting on BRCA biomarkers.
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.
CMS's move to restrict coverage could limit test access for early-stage cancer patients and negatively impact lab revenues.
In a letter to CMS, AMP made a case for crosswalking existing CPT codes for BRCA1/2 testing to codes that more accurately reflect the work required to analyze these genes.
The test is now approved as a CDx for advanced ovarian cancer patients considering Lynparza as a first-line maintenance treatment.
The test is approved to gauge germline BRCA mutations in advanced breast cancer patients who may benefit from treatment with Pfizer's PARP inhibitor Talzenna.