Natera shares soar as Japan approves its cancer detection product

The approval by the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan supports the use of Signatera for adjuvant therapy in colorectal cancer (CRC) patients. Leerink Partners analyst Puneet Souda believes that the approval from Japan’s PMDA is “an incremental positive for NTRA, as Japanese clinical practice guidelines already support clinically validated ctDNA MRD (molecular residual disease) testing.” “We still think this approval expands its total addressable market (TAM), and there may be additional indications approved in the future, including muscle invasive bladder cancer (MIBC).” RBC Capital Markets analyst Dan Leonard stated that the approval by PMDA was expected and further consolidates the Japanese market’s position as a significant incremental opportunity, “although we anticipate it will take some time for the market to reach meaningful scale.” Piper Sandler analyst David Westenberg said, “We see this as a major catalyst for Natera, especially considering the favorable environment in the Japanese market. Though historically the international market opportunity for specialty diagnostics has been limited, Japan has certain factors that could make it a unique and highly compatible market.”