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Signatera™ Receives Regulatory Approval in Japan as a Companion Diagnostic in Muscle-Invasive Bladder Cancer

Key Takeaway: Natera, Inc. has announced that its Signatera test has received regulatory approval from Japan's Pharmaceuticals and Medical Devices Agency as a companion diagnostic for muscle-invasive bladder cancer. This approval allows the test to assist in guiding treatment decisions for patients receiving adjuvant atezolizumab. Natera anticipates commercial availability following this approval.

Market Sentiment Analysis

POSITIVE FACTORS

  • Signatera test approved as a companion diagnostic in Japan.
  • Approval supports treatment decisions for muscle-invasive bladder cancer.
  • Natera is a leader in cell-free DNA and precision medicine.

Full Press Release Details

AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that its Signatera test has received regulatory approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) as a companion diagnostic (CDx) in muscle-invasive bladder cancer (MIBC). This approval supports the use of the Signatera test to guide adjuvant atezolizumab (Tecentriq®) treatment decisions in patients with MIBC. Natera expects to commercially

Frequently Asked Questions

What is the Signatera test?

The Signatera test is a precision medicine tool that analyzes cell-free DNA.

What does the regulatory approval mean?

It allows the Signatera test to be used as a companion diagnostic in Japan.

Which cancer is the Signatera test approved for?

It is approved for muscle-invasive bladder cancer (MIBC).

What treatment decisions does it support?

It guides adjuvant atezolizumab treatment decisions for patients.

Last updated: Sep 22, 2026