First PMDA-approved molecular residual disease (MRD) test enters Japan
Singapore, June 24 -- US-based Natera, Inc., a global leader in cell-free DNA and precision medicine, has announced that Signatera has received regulatory approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA).
This approval supports the use of Signatera for patients with colorectal cancer (CRC) in the adjuvant setting and makes Signatera the first PMDA-approved MRD test in Japan. Natera expects to commercially launch Signatera for CRC in Japan by the end of 2026, subject to final pricing determination.
More than 150,000 people are diagnosed with CRC in Japan each year, making it one of the country's most common cancers. This disease burden is comparable to that of the United States and highlights the need for more indi...
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