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Natera's Signatera Wins Japan PMDA Approval as Bladder Cancer CDx

Zacks Investment Research·
Natera's Signatera Wins Japan PMDA Approval as Bladder Cancer CDx

Natera announced that its Signatera test received regulatory approval from Japan's PMDA as a companion diagnostic for muscle-invasive bladder cancer (MIBC), supporting Signatera-guided adjuvant atezolizumab treatment decisions. The approval, supported by IMvigor011 Phase III trial data, marks the company's second PMDA authorization in three months. Commercial launch in Japan is planned for H1 2027. The stock gained 5.5% following the announcement.

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