WASHINGTON (dpa-AFX) - Natera, Inc. (NTRA), a genetic testing company said on Wednesday that it has filed for approval in Japan to use its Signatera test as a companion diagnostic for patients with muscle-invasive bladder cancer.
The application was submitted to Japan's Pharmaceuticals and Medical Devices Agency, Natera said.
The company is seeking approval to use Signatera to guide treatment with adjuvant atezolizumab in muscle-invasive bladder cancer. The filing is backed by data from IMvigor011, a Phase 3 trial.
Signatera was approved by Japan's regulator in June for use in colorectal cancer, the first molecular residual disease test to gain PMDA clearance in the country.
In pre market activity on Nasdaq, shares of Natera were up 0.68 percent, changing hands at $277.06, after closing Tuesday's regular session 1.79 percent higher.
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