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News and reporting on BRCA biomarkers.
While almost 57,000 labs received Medicare payments for labs performed last year, just three labs received 15 percent of the total Medicare lab payments.
The FDA will consider the companion diagnostic application alongside data for Pfizer's talazoparib in BRCA-mutated advanced breast cancer.
The Center for Genomic Interpretation and NSGC want payors to cover confirmatory testing for patients with positive results from 23andMe's FDA-cleared test.
The funding will be available to members of the Association of Community Cancer Centers, a cancer care provider advocacy group.
The firm will provide its genetic testing, counseling, and cascade screening to patients seen at a group of US health systems, focusing on CDC Tier 1 conditions.
The test is approved as a companion diagnostic that can determine which advanced breast cancer patients have BRCA1/2 genetic mutations and will likely respond to Lynparza.
The 4,000-participant study will use a digital enrollment platform and will provide free genetic testing as well as support from doctors and genetics experts.
FDA's blessing for 23andMe's test that gauges select BRCA1/2 variants has the cancer community worried about whether consumers will understand its limitations.
23andMe's genetic health report is for three BRCA1 and BRCA2 mutations most commonly found in people of Ashkenazi Jewish descent.
The company discussed its efforts to grow adoption of its products during a call to discuss second quarter financial results for fiscal year 2018.