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Natera Submits Signatera™ to Japan’s PMDA for Approval as a Companion Diagnostic in Muscle-Invasive Bladder Cancer

Key Takeaway: Natera, Inc. has submitted an application to Japan's PMDA for the approval of its Signatera test as a companion diagnostic for muscle-invasive bladder cancer. This submission marks a strategic move to enhance Natera's presence in the Japanese market, following the earlier approval of Signatera for colorectal cancer. The approval could potentially broaden treatment options for patients in Japan.

Market Sentiment Analysis

POSITIVE FACTORS

  • Natera is expanding its presence in Japan.
  • Signatera has already received PMDA approval for colorectal cancer.
  • The submission for muscle-invasive bladder cancer represents a significant advancement.

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 it has submitted an application to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for approval of the Signatera test in muscle-invasive bladder cancer (MIBC) as a companion diagnostic (CDx). The submission advances Natera’s growing presence in Japan, where Signatera received PMDA approval in colorectal cancer in June, becoming the country’s first

Frequently Asked Questions

What is the Signatera test?

The Signatera test is a precision medicine tool developed by Natera for detecting cancer.

What is the significance of PMDA approval?

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

For which type of cancer is Signatera submitted?

Signatera has been submitted for approval as a companion diagnostic in muscle-invasive bladder cancer.

When did Signatera receive PMDA approval for colorectal cancer?

Signatera received PMDA approval for colorectal cancer in June.

Last updated: Aug 5, 2026