WASHINGTON (dpa-AFX) - Natera, Inc. (NTRA) announced that its Signatera test has received regulatory approval from Japan's Pharmaceuticals and Medical Devices Agency as a companion diagnostic in muscle-invasive bladder cancer. The approval supports the use of the Signatera test to guide adjuvant atezolizumab treatment decisions in patients with MIBC. Natera expects to commercially launch Signatera for MIBC in Japan in the first half of 2027, following the PMDA's approval of atezolizumab in MIBC.
The regulatory approval was supported by data from IMvigor011, a randomized, double-blind phase III clinical trial. The company said this marks Signatera's second PMDA authorization in Japan, after receiving approval in colorectal cancer in June 2026.
In pre-market trading on NasdaqGS, Natera shares are down 1.47 percent to $365.20.
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