Myriad Genetics announced that Japan’s Ministry of Health, Labour and Welfare has approved its MyChoice test for prostate cancer patients, extending the test’s coverage beyond breast and ovarian cancer to include this indication.
The MyChoice test determines homologous recombination deficiency (HRD) status and BRCA1/2 mutations in tumor tissue, enabling clinicians to identify patients who may benefit from PARP‑inhibitor therapy such as Lynparza (olaparib).
Japan’s prostate cancer market is sizable, with more than 100,000 new cases each year. The approval opens a new revenue stream for Myriad in a country where precision‑medicine diagnostics are increasingly reimbursed under the National Health Insurance system.
The expansion aligns with Myriad’s strategy to broaden its precision‑medicine portfolio. By adding a companion diagnostic for a high‑growth indication, the company can capture a share of the projected $438 million prostate cancer diagnostics market in Japan by 2030 and the $2.96 billion therapy market by 2032.
Myriad’s Q4 2025 results—$209.8 million in revenue and an adjusted EPS of $0.04—were driven by strong demand for its core hereditary cancer tests. The company reiterated full‑year 2026 revenue guidance of $860–$880 million and an adjusted gross margin of 68–69 percent, indicating confidence that the new approval will contribute to its revenue mix without eroding margins.
Brian Donnelly, Chief Commercial Officer, said, “Expanding the MyChoice test into prostate cancer marks an important milestone for Myriad Genetics in Japan. Previously, MyChoice testing was only reimbursed under Japan’s National Health Insurance for breast and ovarian cancer patients, so this new approval broadens access to critical genomic insights that help clinicians make informed treatment decisions for their patients.” Dr. Hiroji Uemura, Project Professor at Yokohama City University Graduate School of Medicine, added, “The reimbursement approval of MyChoice for prostate cancer provides a new testing option for patients with castration‑resistant prostate cancer. In addition to the previously available germline BRCA1/2 testing, the inclusion of tumor‑based testing is expected to expand the number of patients who may benefit from treatment with PARP inhibitors.”
The approval positions Myriad to leverage its existing expertise in HRD and BRCA testing for a new indication, potentially accelerating revenue growth in Japan’s precision‑medicine segment while reinforcing its global strategy to expand companion diagnostics for targeted therapies.
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