We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
NTRA's Signatera CDx Wins FDA Nod in Muscle-Invasive Bladder Cancer
Read MoreHide Full Article
Key Takeaways
NTRA secured FDA approval for Signatera CDx with Tecentriq in muscle-invasive bladder cancer.
Signatera helped identify MIBC patients benefiting from Tecentriq in the Phase III IMvigor011 trial.
Natera said MRD-negative patients showed 97% two-year survival without adjuvant therapy.
Natera, Inc. (NTRA - Free Report) recently announced the FDA approval of Signatera CDx as a companion diagnostic (CDx) for use with adjuvant atezolizumab (Tecentriq) immunotherapy in patients with muscle-invasive bladder cancer (MIBC). The approval marks the first companion diagnostic approval in the blood-based minimal residual disease (MRD) testing space and represents a major milestone in personalized oncology care.
Management stated the FDA approval was an achievement for precision oncology and personalized medicine. It supports the company’s decade-long vision for Signatera and strengthens its position as a standard-of-care MRD solution in muscle-invasive bladder cancer. Natera’s expanding portfolio of TOMR trials and innovations in genome-based MRD and phased variant technologies aims at advancing cancer diagnostics across all cancer types.
Likely Trend of NTRA Stock Following the News
Shares of NTRA have lost 5.4% since the announcement on Friday. In the year-to-date period, shares of the company have fallen 14.7% compared with the industry’s 11.9% decline. However, the S&P 500 has risen 9% in the same timeframe.
The FDA approval of Signatera CDx as a companion diagnostic may accelerate adoption among oncologists and healthcare systems seeking personalized treatment approaches in bladder cancer care. Continued advancements in MRD-guided treatment strategies may further enhance Natera’s competitive standing in the fast-growing precision oncology and MRD diagnostics market.
NTRA currently has a market capitalization of $26.69 billion.
Image Source: Zacks Investment Research
More on the News
The FDA approval follows positive findings from the global Phase III IMvigor011 trial sponsored by Genentech and published in The New England Journal of Medicine in October 2025. The study demonstrated that MRD-positive MIBC patients treated with Tecentriq achieved significant improvements in disease-free survival and overall survival.
Meanwhile, MRD-negative patients achieved a 97% two-year overall survival rate without receiving adjuvant therapy, highlighting the potential of Signatera to help personalize treatment decisions while avoiding unnecessary therapy exposure.
Currently, around 30,000 new MIBC cases are diagnosed annually in the United States and nearly 150,000 worldwide. While radical cystectomy can provide long-term disease control for some patients, identifying those at high risk of recurrence has remained challenging. Findings from the IMvigor011 trial provide evidence that MRD-guided treatment using Signatera may help personalize care decisions across the bladder cancer treatment continuum.
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
In March, Natera announced the commercial launch of Zenith Genomics, a next-generation whole genome sequencing assay designed to improve the detection and diagnosis of rare genetic diseases. The core technology behind Zenith Genomics was developed by MyOme, a clinical whole genome analysis company focused on helping families better understand and assess their disease risks.
West Pharmaceutical reported first-quarter 2026 earnings per share (EPS) of $2.13, which beat the Zacks Consensus Estimate by 26.8%. Revenues of $844.9 million surpassed the Zacks Consensus Estimate by 8.5%.
West Pharmaceutical has an estimated long-term earnings growth rate of 13.9%. WST’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 19.4%.
Globus Medical reported first-quarter 2026 adjusted EPS of $1.12, which surpassed the Zacks Consensus Estimate by 22.1%. Revenues of $759.9 million beat the Zacks Consensus Estimate by 4.0%.
Globus Medical has an estimated long-term earnings growth rate of 10.2%. GMED’s earnings beat estimates in each of the trailing four quarters, the average surprise being 26.3%.
Intuitive Surgical reported first-quarter 2026 adjusted EPS of $2.50, which beat the Zacks Consensus Estimate by 20.2%. Revenues of $2.77 billion surpassed the Zacks Consensus Estimate by 6.2%.
Intuitive Surgical has a long-term estimated growth rate of 14.6%. ISRG’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 16.8%.
Zacks' 7 Best Strong Buy Stocks (New Research Report)
Valued at $99, click below to receive our just-released report
predicting the 7 stocks that will soar highest in the coming month.
View the Zacks #1 Rank List
Image: Bigstock
NTRA's Signatera CDx Wins FDA Nod in Muscle-Invasive Bladder Cancer
Key Takeaways
Natera, Inc. (NTRA - Free Report) recently announced the FDA approval of Signatera CDx as a companion diagnostic (CDx) for use with adjuvant atezolizumab (Tecentriq) immunotherapy in patients with muscle-invasive bladder cancer (MIBC). The approval marks the first companion diagnostic approval in the blood-based minimal residual disease (MRD) testing space and represents a major milestone in personalized oncology care.
Management stated the FDA approval was an achievement for precision oncology and personalized medicine. It supports the company’s decade-long vision for Signatera and strengthens its position as a standard-of-care MRD solution in muscle-invasive bladder cancer. Natera’s expanding portfolio of TOMR trials and innovations in genome-based MRD and phased variant technologies aims at advancing cancer diagnostics across all cancer types.
Likely Trend of NTRA Stock Following the News
Shares of NTRA have lost 5.4% since the announcement on Friday. In the year-to-date period, shares of the company have fallen 14.7% compared with the industry’s 11.9% decline. However, the S&P 500 has risen 9% in the same timeframe.
The FDA approval of Signatera CDx as a companion diagnostic may accelerate adoption among oncologists and healthcare systems seeking personalized treatment approaches in bladder cancer care. Continued advancements in MRD-guided treatment strategies may further enhance Natera’s competitive standing in the fast-growing precision oncology and MRD diagnostics market.
NTRA currently has a market capitalization of $26.69 billion.
Image Source: Zacks Investment Research
More on the News
The FDA approval follows positive findings from the global Phase III IMvigor011 trial sponsored by Genentech and published in The New England Journal of Medicine in October 2025. The study demonstrated that MRD-positive MIBC patients treated with Tecentriq achieved significant improvements in disease-free survival and overall survival.
Meanwhile, MRD-negative patients achieved a 97% two-year overall survival rate without receiving adjuvant therapy, highlighting the potential of Signatera to help personalize treatment decisions while avoiding unnecessary therapy exposure.
Currently, around 30,000 new MIBC cases are diagnosed annually in the United States and nearly 150,000 worldwide. While radical cystectomy can provide long-term disease control for some patients, identifying those at high risk of recurrence has remained challenging. Findings from the IMvigor011 trial provide evidence that MRD-guided treatment using Signatera may help personalize care decisions across the bladder cancer treatment continuum.
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
In March, Natera announced the commercial launch of Zenith Genomics, a next-generation whole genome sequencing assay designed to improve the detection and diagnosis of rare genetic diseases. The core technology behind Zenith Genomics was developed by MyOme, a clinical whole genome analysis company focused on helping families better understand and assess their disease risks.
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 West Pharmaceutical (WST - Free Report) , Globus Medical (GMED - Free Report) and Intuitive Surgical (ISRG - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
West Pharmaceutical reported first-quarter 2026 earnings per share (EPS) of $2.13, which beat the Zacks Consensus Estimate by 26.8%. Revenues of $844.9 million surpassed the Zacks Consensus Estimate by 8.5%.
West Pharmaceutical has an estimated long-term earnings growth rate of 13.9%. WST’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 19.4%.
Globus Medical reported first-quarter 2026 adjusted EPS of $1.12, which surpassed the Zacks Consensus Estimate by 22.1%. Revenues of $759.9 million beat the Zacks Consensus Estimate by 4.0%.
Globus Medical has an estimated long-term earnings growth rate of 10.2%. GMED’s earnings beat estimates in each of the trailing four quarters, the average surprise being 26.3%.
Intuitive Surgical reported first-quarter 2026 adjusted EPS of $2.50, which beat the Zacks Consensus Estimate by 20.2%. Revenues of $2.77 billion surpassed the Zacks Consensus Estimate by 6.2%.
Intuitive Surgical has a long-term estimated growth rate of 14.6%. ISRG’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 16.8%.