On June 24, Natera rose 9.14% in regular trading, trading at approximately $256.15/share, with turnover of $2.78 billion. The rally was driven by the announcement that Natera's molecular residual disease (MRD) test, Signatera, received regulatory clearance from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for use in colorectal cancer patients.
The approval makes Signatera the first and only officially approved MRD testing tool in Japan, designated to guide post-surgical adjuvant treatment decisions for colorectal cancer patients. The clearance was based on data from the Galaxy clinical trial, which demonstrated that chemotherapy provided benefit to MRD-positive patients after surgery while showing no significant effect in MRD-negative patients. Natera stated that commercial availability in Japan is expected by year-end, subject to final reimbursement approval and pricing decisions.
This regulatory milestone expands Natera's international footprint for its oncology diagnostics portfolio and opens access to the Japanese market, one of the largest healthcare markets globally.
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