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Natera's Signatera Wins Japan PMDA Approval as Bladder Cancer CDx
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Key Takeaways
Natera secured Japan PMDA approval for Signatera as a companion diagnostic in MIBC.
The approval supports Signatera-guided adjuvant atezolizumab decisions after surgery.
IMvigor011 data supported approval, with more than 20 Japanese sites in the Phase III trial.
Natera (NTRA - Free Report) recently announced that its Signatera test received regulatory approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) as a companion diagnostic (CDx) for use in muscle-invasive bladder cancer (MIBC). The approval supports Signatera-guided decisions for adjuvant atezolizumab (Tecentriq) treatment and marks the company’s second PMDA authorization for Signatera in three months. NTRA plans to commercially launch Signatera for MIBC in Japan in the first half of 2027.
Management stated that the company looks forward to launching its second Signatera MRD indication in Japan, providing patients with MIBC a diagnostic tool to guide treatment decisions during the first year after surgery. Natera highlighted its growing partnership with the Japanese oncology community, which has been actively adopting MRD in clinical trials and clinical practice.
Likely Trend of NTRA Stock Following the News
Following the announcement, NTRA stock gained 5.5% at yesterday’s close. Year to date, shares of the company have rallied 70.6% compared with the industry’s 4.2% growth and the S&P 500’s 13% gain.
The PMDA approval may support broader adoption of Signatera in Japan’s MIBC treatment landscape and expand Natera’s international presence in MRD-guided oncology care. Greater adoption of MRD testing could also improve recurring testing volumes and deepen Natera’s competitive position in the rapidly developing precision oncology market.
NTRA currently has a market capitalization of $53.43 billion.
Image Source: Zacks Investment Research
More on the News
The regulatory approval was supported by data from the IMvigor011 randomized, double-blind Phase III clinical trial, which evaluated Signatera-guided adjuvant atezolizumab in patients with MIBC. The trial included more than 20 participating sites in Japan, providing Japanese clinicians with experience using Signatera-guided treatment in this setting.
The PMDA authorization follows Signatera’s approval in colorectal cancer in Japan in June 2026. It also follows the FDA approval of Signatera as a CDx for adjuvant atezolizumab in MIBC, along with the FDA approval of atezolizumab for the indication.
The National Comprehensive Cancer Network’s Clinical Practice Guidelines for Bladder Cancer recently issued a Category 1 recommendation for MRD-guided adjuvant atezolizumab. These regulatory and clinical developments could support the broader integration of MRD testing into bladder cancer treatment decisions.
Bladder cancer affects more than 34,000 people annually in Japan, with approximately 20-25% of newly diagnosed cases classified as MIBC. The higher recurrence risk and treatment complexity associated with MIBC underscore the need for precision diagnostic tools that can help clinicians individualize adjuvant treatment decisions.
Industry Prospects Favoring the Market
Going by the data provided by Precedence Research, the minimal residual disease (MRD) testing market was valued at $1.70 billion in 2025 and is expected to witness a CAGR of 12% through 2034.
Factors like the demand for highly sensitive technologies like next-generation sequencing (NGS) and digital PCR (dPCR), which accurately detect minimal residual cancer cells to guide treatment decisions and predict patient outcomes, are boosting the market’s growth.
Other News
Last month, Natera announced a national partnership with Susan G. Komen to advance breast cancer awareness, education and research. The collaboration will expand understanding of MRD testing and support patient education initiatives. Natera will also serve as the 2026 Premier National Series Sponsor of Komen’s Race for the Cure and MORE THAN PINK Walk events.
Natera announced a collaboration with Angiex, Inc. to assess treatment response to AGX101, an investigational nuclear-delivered antibody-drug conjugate (ND-ADC), using its Signatera test. The Phase 1 trial is evaluating AGX101 in patients with unresectable, locally advanced or metastatic solid tumors.
Veracyte, currently sporting a Zacks Rank #1 (Strong Buy), reported a second-quarter 2026 adjusted earnings per share (EPS) of 54 cents, which surpassed the Zacks Consensus Estimate by 25.6%. Revenues of $150.3 million beat the Zacks Consensus Estimate by 4.1%. You can see the complete list of today’s Zacks #1 Rank stocks here.
VCYT has an estimated earnings growth rate of 8.4% for 2026. The company’s earnings beat estimates in each of the trailing four quarters, the average surprise being 41.8%.
Globus Medical, currently flaunting a Zacks Rank #1, reported a second-quarter 2026 adjusted EPS of $1.34, which surpassed the Zacks Consensus Estimate by 19.6%. Revenues of $789.6 million beat the Zacks Consensus Estimate by 0.4%.
GMED has an estimated long-term earnings growth rate of 12.4%. The company’s earnings beat estimates in each of the trailing four quarters, the average surprise being 27.9%.
Intuitive Surgical, carrying a Zacks Rank #2 (Buy) at present, reported second-quarter 2026 adjusted EPS of $2.80, which beat the Zacks Consensus Estimate by 12.9%. Revenues of $2.89 billion surpassed the Zacks Consensus Estimate by 3.1%.
Intuitive Surgical has a long-term estimated growth rate of 14.9%. ISRG’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 16.5%.
View the Zacks #1 Rank List
Image: Bigstock
Natera's Signatera Wins Japan PMDA Approval as Bladder Cancer CDx
Key Takeaways
Natera (NTRA - Free Report) recently announced that its Signatera test received regulatory approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) as a companion diagnostic (CDx) for use in muscle-invasive bladder cancer (MIBC). The approval supports Signatera-guided decisions for adjuvant atezolizumab (Tecentriq) treatment and marks the company’s second PMDA authorization for Signatera in three months. NTRA plans to commercially launch Signatera for MIBC in Japan in the first half of 2027.
Management stated that the company looks forward to launching its second Signatera MRD indication in Japan, providing patients with MIBC a diagnostic tool to guide treatment decisions during the first year after surgery. Natera highlighted its growing partnership with the Japanese oncology community, which has been actively adopting MRD in clinical trials and clinical practice.
Likely Trend of NTRA Stock Following the News
Following the announcement, NTRA stock gained 5.5% at yesterday’s close. Year to date, shares of the company have rallied 70.6% compared with the industry’s 4.2% growth and the S&P 500’s 13% gain.
The PMDA approval may support broader adoption of Signatera in Japan’s MIBC treatment landscape and expand Natera’s international presence in MRD-guided oncology care. Greater adoption of MRD testing could also improve recurring testing volumes and deepen Natera’s competitive position in the rapidly developing precision oncology market.
NTRA currently has a market capitalization of $53.43 billion.
Image Source: Zacks Investment Research
More on the News
The regulatory approval was supported by data from the IMvigor011 randomized, double-blind Phase III clinical trial, which evaluated Signatera-guided adjuvant atezolizumab in patients with MIBC. The trial included more than 20 participating sites in Japan, providing Japanese clinicians with experience using Signatera-guided treatment in this setting.
The PMDA authorization follows Signatera’s approval in colorectal cancer in Japan in June 2026. It also follows the FDA approval of Signatera as a CDx for adjuvant atezolizumab in MIBC, along with the FDA approval of atezolizumab for the indication.
The National Comprehensive Cancer Network’s Clinical Practice Guidelines for Bladder Cancer recently issued a Category 1 recommendation for MRD-guided adjuvant atezolizumab. These regulatory and clinical developments could support the broader integration of MRD testing into bladder cancer treatment decisions.
Bladder cancer affects more than 34,000 people annually in Japan, with approximately 20-25% of newly diagnosed cases classified as MIBC. The higher recurrence risk and treatment complexity associated with MIBC underscore the need for precision diagnostic tools that can help clinicians individualize adjuvant treatment decisions.
Industry Prospects Favoring the Market
Going by the data provided by Precedence Research, the minimal residual disease (MRD) testing market was valued at $1.70 billion in 2025 and is expected to witness a CAGR of 12% through 2034.
Factors like the demand for highly sensitive technologies like next-generation sequencing (NGS) and digital PCR (dPCR), which accurately detect minimal residual cancer cells to guide treatment decisions and predict patient outcomes, are boosting the market’s growth.
Other News
Last month, Natera announced a national partnership with Susan G. Komen to advance breast cancer awareness, education and research. The collaboration will expand understanding of MRD testing and support patient education initiatives. Natera will also serve as the 2026 Premier National Series Sponsor of Komen’s Race for the Cure and MORE THAN PINK Walk events.
Natera announced a collaboration with Angiex, Inc. to assess treatment response to AGX101, an investigational nuclear-delivered antibody-drug conjugate (ND-ADC), using its Signatera test. The Phase 1 trial is evaluating AGX101 in patients with unresectable, locally advanced or metastatic solid tumors.
Natera, Inc. Price
Natera, Inc. price | Natera, Inc. Quote
NTRA’s Zacks Rank & Key Picks
Natera currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are Veracyte (VCYT - Free Report) , Globus Medical (GMED - Free Report) and Intuitive Surgical (ISRG - Free Report) .
Veracyte, currently sporting a Zacks Rank #1 (Strong Buy), reported a second-quarter 2026 adjusted earnings per share (EPS) of 54 cents, which surpassed the Zacks Consensus Estimate by 25.6%. Revenues of $150.3 million beat the Zacks Consensus Estimate by 4.1%. You can see the complete list of today’s Zacks #1 Rank stocks here.
VCYT has an estimated earnings growth rate of 8.4% for 2026. The company’s earnings beat estimates in each of the trailing four quarters, the average surprise being 41.8%.
Globus Medical, currently flaunting a Zacks Rank #1, reported a second-quarter 2026 adjusted EPS of $1.34, which surpassed the Zacks Consensus Estimate by 19.6%. Revenues of $789.6 million beat the Zacks Consensus Estimate by 0.4%.
GMED has an estimated long-term earnings growth rate of 12.4%. The company’s earnings beat estimates in each of the trailing four quarters, the average surprise being 27.9%.
Intuitive Surgical, carrying a Zacks Rank #2 (Buy) at present, reported second-quarter 2026 adjusted EPS of $2.80, which beat the Zacks Consensus Estimate by 12.9%. Revenues of $2.89 billion surpassed the Zacks Consensus Estimate by 3.1%.
Intuitive Surgical has a long-term estimated growth rate of 14.9%. ISRG’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 16.5%.