News and reporting on BRCA biomarkers.
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.
The Seoul-based company also recently raised $1.9 million in series B funding and is targeting between $7 million and $8 million to close the round.
NGeneBio said this week that its next-generation sequencing panel has been approved as an IVD, the first NGS test to be cleared in Korea.
Myriad Genetics' BRACAnalysis CDx can identify which metastatic patients have BRCA mutations and would likely benefit from treatment with AstraZeneca's Lynparza.
The drugmaker is subsidizing the cost of BRCA testing for women diagnosed with ovarian cancers, for whom guidelines now recommend such testing for cancer therapy selection.
Those involved in the project hope to demonstrate that a screening program that provides BRCA testing to women starting age 30 can be cost-effective and a public health benefit.
If approved, the companion test can be used to identify which metastatic breast cancer patients have mutations in BRCA1/2 genes and are likely to respond to Lynparza.