Skip to main content
Premium Trial:

Request an Annual Quote

Myriad Genetics Submits BRACAnalysis CDx for Approval in Japan

NEW YORK (GenomeWeb) – Myriad Genetics has submitted BRACAnalysis CDx for review by Japan's Pharmaceutical Medical Devices Agency and for marketing approval by its Ministry of Health, Labor and Welfare.

If approved, the companion diagnostic can be used to identify which HER2-negative, metastatic breast cancer patients have germline mutations in BRCA1 and BRCA2 genes and are likely to respond to AstraZeneca's Lynparza (olaparib).

"This regulatory submission as a companion diagnostic for a PARP inhibitor outside the US reflects another important major milestone as Myriad seeks to become a global leader in personalized medicine,” Myriad CEO Mark Capone said in a statement.

Myriad will perform testing for the Japanese market in its US lab. The company estimated that in Japan each year there are more than 10,000 cases of HER2-negative metastatic breast cancer eligible for testing with BRACAnalysis CDx.

Earlier this month, the company said that the US Food and Drug Administration had accepted its supplementary premarket approval application for BRACAnalysis CDx alongside Lynparza in the same breast cancer setting. The test is already approved as a CDx for Lynparza for patients with germline BRCA-mutated advanced ovarian cancer, who have received three or more prior lines of chemotherapy.

The Scan

Looking for Omicron

NPR reports that SARS-CoV-2 testing in the US has gotten better but also that some experts say more needs to be done to better track the Omicron variant.

Holmes Alleges Abuse

The Associated Press reports that Theranos' Elizabeth Holmes has testified at her wire fraud trial that her business and romantic partner abused her.

Bit More Diverse, But More to Do

While Black and Hispanic patients are more likely to participate in cancer clinical trials than previously, they are still underrepresented, according to US News & World Report.

PNAS Papers on Yeast Gene Silencing, Zika Virus Inhibition, Immunoglobulin Hypermutation

In PNAS this week: gene silencing in Saccharomyces cerevisiae, possible neuroprotective role for SHFL in a mouse model of Zika virus infection, and more.