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News and reporting on BRCA biomarkers.
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.
The agency has granted the drug and CDx priority review, which Myriad expects to conclude during its fiscal third-quarter ending March 31, 2018.
The company has made agreements with two cancer diagnostics firms — GenomeDx, and Cynvenio — bundling its hereditary germline analysis with their somatic tests.
NGeneBio is moving ahead with plans to have the test cleared for diagnostic use in Korea, while envisioning a 2019 submission to the US FDA.
The Korean molecular diagnostics startup is planning to launch the new offering in Europe, as well as China and other Southeast Asian countries.