US Market News
3週前
Natera to Present 35 Studies at ASCO, Extending Clinical Data Leadership in OncologyMay 21, 2026 5:05 PM
Business Wire Overall program, including 3 oral presentations, delivers unmatched evidence across the MRD landscape Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced a landmark oncology data program for the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The meeting will take place May 29–June 2 in Chicago, IL. Together with its collaborators, Natera will demonstrate unmatched scale in evidence generation with 35 abstracts across molecular residual disease (MRD) testing and other innovations. Presentations will highlight Natera’s Treatment on MRD (TOMR) approach, showing more precise intervention upon molecular recurrence; the broad utility of Signatera as a pan-cancer foundational tool in MRD; the robust clinical performance of Natera’s ultrasensitive phased variant technology; and new real-world data on Signatera in hereditary risk assessment, treatment response monitoring, and longitudinal disease management. “This is the most comprehensive oncology data program Natera has presented to date, reflecting the growing adoption of Signatera and the accelerating momentum behind precision MRD-guided care,” said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology. “Collectively, these studies reinforce Signatera’s broad clinical utility, highlight the continued advancement of our technology platform, and demonstrate the strength and depth of our evidence as we work to make cancer care more actionable and personalized.” Treatment on MRD (TOMR) in Colorectal Cancer (CRC) Multiple analyses from the GALAXY study in CRC demonstrate the value of serial Signatera testing and the potential impact of MRD-guided decision making in the adjuvant setting. In one analysis, patients who were initially Signatera-negative but later converted to Signatera-positive derived a substantial benefit from adjuvant chemotherapy (ACT) (HR 0.3), showing Signatera can identify a subset of patients with early molecular recurrence who could benefit from ACT. Patients with sustained negativity had excellent outcomes regardless of ACT, suggesting potential overtreatment. A separate analysis showed that extending ACT beyond three months provided no added benefit for patients with sustained Signatera-negativity or Signatera clearance, whereas partial molecular responders (decrease in ctDNA) benefitted from continued ACT. Molecular progression (increase in ctDNA) on ACT indicated the need for more effective alternative treatment strategies. Pan-Cancer MRD Natera will present a large, first-of-its-kind, real-world meta-analysis of Signatera across 18 published studies, more than 3,000 patients, and 15 tumor types. The analysis demonstrated that Signatera-positivity was strongly associated with increased risk of recurrence or disease progression at all timepoints included in the analysis. In a pooled analysis, Signatera-positivity in the adjuvant window was associated with significantly increased risk of recurrence or death (HR: 8.15). In the surveillance setting, Signatera-positivity was associated with an even greater recurrence risk (HR: 18.30). Phased Variant Technology Natera’s phased variant technology continues to demonstrate powerful prognostic performance across both solid and hematologic cancers. This technology, which can detect circulating tumor DNA (ctDNA) levels below 1 part per 10 million, reinforces the potential of ultra-sensitive ctDNA detection to guide treatment response monitoring and long-term disease management. One study in early-stage, non-small cell lung cancer (NSCLC), showed that 100% of patients who cleared ctDNA during or after adjuvant therapy did not recur. ctDNA detection also preceded recurrence in 94% of cases. In a separate analysis in relapsed or refractory follicular lymphoma, patients treated with CAR T cell therapy who achieved MRD-negativity experienced substantially improved progression-free survival (PFS), including 36-month PFS rates of 81% compared to 56% in MRD-positive patients. Platform Expansion: RWD and New Digital Tools Natera and its collaborators will present real world data evaluating ctDNA dynamics and clinical outcomes in colorectal cancer, NSCLC, breast cancer, and additional tumor types. Natera will also unveil its Annotation platform at ASCO, a new digital tool that integrates clinical, treatment, and genomic data to present multimodal, longitudinal patient journeys through a unified interface, bringing richer clinical context to Signatera results at the individual and cohort levels. A full list of abstracts is included here. About Natera Natera™ is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 400 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. For more information, visit www.natera.com. Forward-Looking Statements All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov. View source version on businesswire.com: https://www.businesswire.com/news/home/20260521853793/en/ Investor Relations: Mike Brophy, CFO, Natera, Inc., investor@natera.com
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com Original: Natera to Present 35 Studies at ASCO, Extending Clinical Data Leadership in Oncology
US Market News
4週前
Signatera™ CDx Approved by the FDA as a Companion Diagnostic in Muscle-Invasive Bladder Cancer (MIBC)May 15, 2026 12:45 PM
Business Wire Marks the first FDA-approved use of personalized molecular residual disease (MRD) testing to guide treatment decisions Solidifies Natera’s Treatment on MRD (TOMR) approach as the new standard of care in MIBC, enabling precision interventions for MRD-positive patients while sparing MRD-negative patients from potentially unnecessary treatment Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that the U.S. Food and Drug Administration (FDA) has approved Signatera CDx as a companion diagnostic (CDx) for use with adjuvant atezolizumab (Tecentriq®) immunotherapy in MIBC. This is the first companion diagnostic approval in the field of blood-based MRD. It is a significant milestone in the industry-wide shift toward personalized, MRD-guided cancer care, in which treatment decisions may depend on Signatera™ MRD status, and interventions may be delayed or deferred for patients who remain MRD-negative. Supported by more than 185 peer-reviewed publications and Medicare coverage across multiple cancer types (including Bladder, Breast, Lung, Colorectal, Ovarian, and pan-cancer immunotherapy monitoring), Signatera has become a cornerstone of precision oncology. Signatera CDx has been approved by the FDA for use with adjuvant atezolizumab (Tecentriq®) to identify patients with MIBC who are ctDNA MRD-positive and may benefit from treatment. This follows The New England Journal of Medicine publication in October 2025 of the landmark, global Phase III IMvigor011 trial, sponsored by Genentech. The trial results demonstrated that Signatera MRD-positive patients treated with immunotherapy achieved significant improvements in disease-free survival (DFS) and overall survival (OS), while Signatera MRD-negative patients achieved 97% 2-year OS with no adjuvant therapy at all. “The practice-changing IMvigor011 trial and this approval signal a transformation in cancer care, where MRD is guiding when to treat, whom to treat, and how to treat more precisely,” said Professor Thomas Powles, lead principal investigator of IMvigor011 and Chair of Barts Cancer Centre at St. Bartholomew’s Hospital. “Historically, we relied on imaging to tell us when cancer had returned, but that also meant millions of cancer cells were already present in the body. As we saw with IMvigor011 and in several other trials, Signatera detected tumor DNA at an earlier timepoint and provided us with a significant head start to improve outcomes for patients.” “For bladder cancer patients and families, the period after bladder removal can be filled with uncertainty,” said Meri-Margaret Deoudes, CEO of the Bladder Cancer Advocacy Network. “Approaches like Signatera can help clarify which patients are more likely to experience recurrence, giving clinicians additional important information as they consider next steps. Our priority is ensuring that patients and families have access to tools that support informed decision-making, reduce unnecessary treatment when possible, and help guide timely care when it’s needed.” “This FDA approval is a major milestone for the field of precision oncology and personalized medicine,” said Solomon Moshkevich, president of clinical diagnostics at Natera. “This validates the vision that Natera introduced 10 years ago and solidifies Signatera MRD as the new standard of care in muscle-invasive bladder cancer. With our growing portfolio of TOMR trials and our recent innovations in ultrasensitive genome-based MRD and phased variant technologies, Natera continues to drive forward the science across all cancer types.” There are approximately 30,000 new diagnoses of MIBC each year in the U.S. and 150,000 globally.1-5 Radical cystectomy, with or without neoadjuvant therapy, is associated with long-term disease control in approximately half of patients with muscle-invasive bladder cancer, but it has historically been difficult to identify which patients are likely to recur and to offer them effective, personalized therapy while sparing others from unnecessary treatment.5-6 With IMvigor011, there is now prospective evidence showing that MRD can guide care for patients in this setting and adds to the growing body of evidence on Signatera across the bladder cancer continuum. Notes Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group. References https://seer.cancer.gov/statfacts/html/urinb.html Patel VG, Oh WK, Galsky MD. Treatment of muscle-invasive and advanced bladder cancer in 2020. CA Cancer J Clin. 2020;70(5):404-423. doi:10:3322/caac.21631 Global Cancer Observatory. Cancer Today GLOBOCAN 2022 Factsheet – Bladder [Internet; cited 2025 October]. Ghandour R, et al. Treatment Options and Outcomes in Nonmetastatic Muscle Invasive Bladder Cancer. Trends Cancer. 2019;5(7):426-39. Stein JP, Lieskovsky G, Cote R, et al. Radical cystectomy in the treatment of invasive bladder cancer: long-term results in 1,054 patients. J Clin Oncol. 2001;19(3):666–675. doi:10.1200/JCO.2001.19.3.666 Yafi FA, Aprikian AG, Chin JL, et al. Contemporary outcomes of 2,287 patients with bladder cancer treated with radical cystectomy: a Canadian multicentre experience. BJU Int. 2011;108(4):539–545. doi:10.1111/j.1464-410X.2010.09912.x About Natera Natera™ is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 350 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. For more information, visit www.natera.com. Forward-Looking Statements All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov. View source version on businesswire.com: https://www.businesswire.com/news/home/20260514529026/en/ Investor Relations: Mike Brophy, CFO, Natera, Inc., investor@natera.com
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com Original: Signatera™ CDx Approved by the FDA as a Companion Diagnostic in Muscle-Invasive Bladder Cancer (MIBC)
US Market News
2月前
20 Abstracts at AACR Highlight Scale, Innovation and Clinical Impact of Natera’s Oncology PlatformApril 7, 2026 6:00 AM
Business Wire
Data from >75,000 patients underscore advances in AI-driven virtual genomics, Signatera™-guided treatment monitoring, and continued expansion of MRD and other capabilities
Natera, Inc. (NASDAQ: NTRA) a global leader in cell-free DNA and precision medicine, today announced that 20 abstracts, including two oral presentations, featuring data generated using its technologies will be presented at the 2026 American Association for Cancer Research® (AACR) Annual Meeting 2026, taking place April 17–22 in San Diego, CA.
These presentations, developed in collaboration with leading academic and clinical partners, span multiple tumor types and applications, including artificial intelligence, digital pathology, molecular residual disease (MRD) and real-world evidence (RWE).
“These presentations reflect both the scale of our platform and the pace of innovation we’re driving across oncology,” said Alexey Aleshin, M.D., corporate chief medical officer and general manager, oncology and early cancer detection at Natera. “From AI-enabled genomic insights to real-world evidence supporting ctDNA-guided treatment decisions, this body of work demonstrates how we are continuing to innovate within and beyond MRD to deliver more precise, data-driven approaches across cancer care.”
Key highlights
Artificial Intelligence
Natera’s oral presentation, A large-scale, multi-target deep learning model for virtual genomic profiling in colorectal cancer, describes a digital pathology deep learning model trained on molecular and histopathology data from more than 45,000 colorectal cancer patients in a first-of-its-kind analysis. The model predicts risk of recurrence, hundreds of genomic alterations and key guideline biomarkers directly from routine H&E images, with an industry-leading area under the receiver operating curve (AUROC) of 0.98 for MSI-status and 0.93 for BRAF V600E status. This highlights the potential to transform routine pathology slides into a scalable, AI-enabled genomic profiling platform, expanding access to high-value molecular data, reducing tissue constraints and accelerating time to treatment decisions.
An additional poster in breast cancer, A machine learning approach to classify breast cancer receptor subtype using genomic features, analyzed data from nearly 20,000 patients. The study concluded that a machine learning model using tumor DNA can accurately classify breast cancer into its major subtypes, including high precision of 93.5% and recall of 91.1% for identifying HR+/HER2- disease.
ctDNA Decision-Making
A second oral presentation, Circulating tumor DNA (ctDNA) clearance dynamics in microsatellite instability-high metastatic (MSI-H) colorectal cancer (CRC) treated with immune checkpoint inhibitors (ICI), includes a real-world analysis of 465 patients with MSI-H metastatic CRC treated with ICI. The data shows that ~40% of patients had early ctDNA clearance on ICI. Signatera negativity at the first post-ICI timepoint was predictive of overall survival (OS), with 3-year OS of 96%. Moreover, MRD dynamics were strongly associated with improved OS with 65% of Signatera-positive patients achieving clearance anytime on or post-ICI.
Platform Expansion
A poster on Natera’s methylation-based, tissue-free MRD platform entitled, Quantification of circulating tumor DNA (ctDNA) in patients using cancer-specific, methylation-based, tissue-free tests for the detection of molecular residual disease (MRD), shows that quantitative ctDNA levels strongly correlate with Signatera quantitative levels across colorectal, breast, lung and bladder cancers. LatitudeTM, Natera’s tissue-free MRD assay, launched in CRC in 2025 and is expected to launch commercially in additional histologies with quantitative features later this year.
A poster in early cancer detection, Performance of a blood-based screening test for the early detection of advanced precancerous lesions, summarizes previously announced PROCEED trial data that showed strong performance of Natera’s blood-based screening assay for detecting advanced precancerous lesions. The study demonstrated sensitivity of 22.5% (CI: 15.4%-32.4%) and specificity of 91.5% (CI: 88.2%-93.9%)?? and encompassed all histologic subtypes, including serrated polyps.
A full list of abstracts is included here.
About Natera
Natera™ is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 400 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. For more information, visit www.natera.com.
Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.
This release is not affiliated with or endorsed by AACR.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260407837545/en/
Investor Relations: Mike Brophy, CFO, Natera, Inc., investor@natera.com
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com
Original: 20 Abstracts at AACR Highlight Scale, Innovation and Clinical Impact of Natera’s Oncology Platform
US Market News
3月前
Signatera™ MRD Data at ASCO GU Highlights Potential Utility Across GU Cancers, Including for Bladder PreservationFebruary 27, 2026 10:05 AM
Business Wire
11 scientific abstracts, including 4 oral presentations and a concurrent publication in Nature Medicine, underscore how Signatera MRD can improve quality of life for patients with genitourinary cancers
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced it will present new data in genitourinary malignancies at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), taking place February 26-28, 2026.
Across four oral presentations in muscle-invasive bladder cancer (MIBC), these data reinforce Signatera’s role in identifying patients who benefit from adjuvant immunotherapy, supporting response-adaptive bladder preservation strategies, and refining molecular residual disease (MRD) detection with plasma circulating tumor DNA (ctDNA) and urinary tumor DNA (utDNA).
Bladder Preservation: INDIBLADE and RETAIN
The INDIBLADE and RETAIN multicenter phase 2 trials demonstrate Signatera’s consistent performance in treatment response monitoring across diverse neoadjuvant regimens in MIBC, with 73-77% of patients demonstrating clearance of ctDNA following therapy and Signatera-negativity showing strong associations with positive outcomes, even with the bladder preserved.
INDIBLADE, the findings of which will be published today in Nature Medicine, investigated induction with combination immune checkpoint inhibitors (ICI) followed by chemoradiotherapy as a bladder-sparing strategy in stage II/III MIBC patients. The results show that Signatera status post-ICI was associated with bladder-intact event-free survival (BI-EFS). Specifically, Signatera-negativity at baseline and post-neoadjuvant therapy was linked to an 88.6% and 91% estimated two-year BI-EFS, respectively.
RETAIN evaluated a clinical response-adapted approach to identify patients for potential bladder-preservation following neoadjuvant therapy. The findings showed that post-treatment ctDNA clearance or negativity was associated with improved metastasis-free survival (MFS), and that Signatera-negative patients with no clinical or radiographic evidence of disease managed with active surveillance achieved MFS comparable to Signatera-negative patients undergoing cystectomy. In contrast, persistent Signatera-positivity was associated with poor outcomes.
Perioperative Care: NIAGARA
This phase 3 randomized perioperative study includes the first-ever presentation of utDNA data with clinical correlation. The combination of utDNA and ctDNA status post-neoadjuvant therapy and pre-cystectomy identified the group with the highest 24-month EFS. utDNA-positivity pre-cystectomy was more strongly associated with residual non-invasive disease vs ctDNA-positivity was more strongly associated with residual invasive disease. These data suggest that the combined assessment of utDNA and ctDNA can provide complementary risk stratification benchmarked against pathologic staging, enabling comprehensive identification of residual disease.
“As treatment options expand in perioperative and bladder preservation settings, we need tools that help us determine who truly requires additional therapy and who may safely avoid it,” said Michiel van der Heijden, M.D., Ph.D., Netherlands Cancer Institute, principal investigator of INDIBLADE and presenting author of the NIAGARA study. “The data presented at ASCO GU demonstrate that MRD assessment with Signatera has strong correlations with outcomes and the potential to inform these critical treatment decisions.”
“Following our milestone PMA submission to the FDA based on IMvigor011, these compelling data presentations reflect our commitment to transforming care across the spectrum of genitourinary malignancies,” said Minetta Liu, M.D., chief medical officer of oncology and early cancer detection at Natera. “The new data suggests a particularly important opportunity for Signatera to optimize clinical decisions around bladder preservation, a major opening to improve patient quality of life.”
The full list of presentations at ASCO GU includes:
February 27, 8:10 AM PT | Abstract #633 (Oral Presentation)
Presenter: Joaquim Bellmunt, M.D.
Circulating tumor (ct)DNA-guided adjuvant atezolizumab (atezo) in muscle-invasive bladder cancer (MIBC): Exploratory analysis of ctDNA dynamics in the IMvigor011 trial
February 27, 8:10 AM PT | Abstract #632 (Oral Presentation)
Presenter: Pooja Ghatalia, M.D.
Circulating tumor DNA (ctDNA) to guide response-adapted bladder preservation in muscle invasive bladder cancer (MIBC): Integrated analysis of the RETAIN trials
February 27, 11:30 AM PT | Abstract #797
Presenter: Can Aydogdu, M.D.
Integrating genomic profiling and circulating tumor DNA monitoring to optimize surveillance strategies in muscle-invasive bladder cancer
February 27, 11:30 AM PT | Abstract #831
Presenter: Can Aydogdu, M.D.
Association of ctDNA status with upstaging, pathologic outcomes, and genomic alterations in high-risk NMIBC
February 27, 2:30 PM PT | Abstract #637 (Oral Presentation)
Presenter: Jan-Jaap J. Mellema, M.D.
Induction ipilimumab plus nivolumab followed by consolidating chemoradiotherapy as bladder-sparing treatment in stage II/III urothelial carcinoma of the bladder: The phase 2 INDIBLADE trial
February 27, 4:00 PM PT | Abstract #636 (Oral Presentation)
Presenter: Michiel van der Heijden, M.D., Ph.D.
Urinary tumor DNA (utDNA) and circulating tumor DNA (ctDNA) in patients (pts) with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA
February 28, 7:00 AM PT | Abstract #532
Presenter: Shuchi Gulati, M.D., M.Sc.
Association of pre-operative circulating tumor DNA (ctDNA) status with clinicopathologic characteristics in patients (pts) with localized renal cell carcinoma (RCC)
February 28, 7:00 AM PT | Abstract #620
Presenter: Dalia Kaakour, M.D., MPH
Use of circulating tumor DNA (ctDNA) in the detection of residual disease and recurrence for patients with testicular cancer
February 27, 11:30 AM PT | Abstract #860
Presenter: Lingbin Meng, M.D., Ph.D.
Use of circulating tumor DNA (ctDNA) in the detection of residual disease and recurrence for patients with testicular cancer
February 27, 11:30 AM PT | Abstract #800
Presenter: Tanya Jindal, BS, BA
Predictive value of early circulating tumor DNA (ctDNA) response in advanced urothelial carcinoma (aUC) treated with enfortumab vedotin plus pembrolizumab (EVP).
February 28, 7:00 AM PT | Abstract #541
Presenter: David F. McDermott, M.D.
Circulating tumor DNA (ctDNA) analysis in participants (pts) with advanced clear cell renal cell carcinoma (ccRCC) treated with first-line pembrolizumab (pembro) monotherapy from the phase 2 KEYNOTE-427 study.
About Natera
Natera™ is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 350 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. For more information, visit www.natera.com.
Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260227178662/en/
Investor Relations: Mike Brophy, CFO, Natera, Inc., investor@natera.com
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com
Original: Signatera™ MRD Data at ASCO GU Highlights Potential Utility Across GU Cancers, Including for Bladder Preservation
US Market News
3月前
Natera Reports Fourth Quarter and Full Year 2025 Financial ResultsFebruary 26, 2026 4:05 PM
Business Wire
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today reported its financial results for the fourth quarter and full year ended December 31, 2025.
Recent Financial Highlights
Generated total revenues of $665.5 million in the fourth quarter of 2025, compared to $476.1 million in the fourth quarter of 2024, an increase of 39.8%. Product revenues grew 39.8% over the same period.
Generated a gross margin1 of 66.9% in the fourth quarter of 2025, compared to a gross margin1 of 62.9% in the fourth quarter of 2024.
Generated total revenues of $2,306.1 million in the full year 2025, compared to $1,696.9 million in the full year 2024, an increase of 35.9%. Product revenues grew 36.2% over the same period.
Generated a gross margin1 of 64.7% in the full year of 2025, compared to a gross margin1 of 60.3% in the full year of 2024.
Processed approximately 923,600 tests in the fourth quarter of 2025, compared to approximately 792,800 tests in the fourth quarter of 2024, an increase of 16.5%.
Processed approximately 3,525,500 tests in the full year 2025, compared to approximately 3,064,600 tests in the full year 2024, an increase of 15.0%.
Processed approximately 233,300 oncology tests in the fourth quarter of 2025, compared to approximately 150,800 in the fourth quarter of 2024, an increase of 54.7%.
Processed approximately 800,800 oncology tests in the full year 2025, compared to approximately 528,200 in the full year 2024, an increase of 51.6%.
Achieved positive cash inflow of approximately $107.6 million2 in the full year 2025.
“We delivered an outstanding finish to 2025 with record test volumes, strong revenue that exceeded our January pre-announcement, and gross margins well ahead of our expectations even as we continued to invest significantly throughout the year,” said Steve Chapman, chief executive officer of Natera. “With solid momentum already in 2026, we remain focused on our mission to transform the management of disease worldwide by expanding access to our testing and advancing the data that supports better patient care.”
Fourth Quarter and Year Ended December 31, 2025 Financial Results
Total revenues were $665.5 million in the fourth quarter of 2025 compared to $476.1 million in the fourth quarter of 2024, an increase of 39.8%. The increase in total revenues was driven primarily by a 39.8% increase in product revenues, which were $661.2 million in the fourth quarter of 2025 compared to $472.9 million in the fourth quarter of 2024. The increase in product revenues was driven by an increase in volume and average selling price improvements.
Natera processed approximately 923,600 tests in the fourth quarter of 2025, including approximately 909,000 tests accessioned in its laboratory, compared to approximately 792,800 tests processed, including approximately 778,400 tests accessioned in its laboratory, in the fourth quarter of 2024.
In the fourth quarter of 2025, Natera recognized revenue on approximately 892,400 tests for which results were reported to customers in the period (tests reported), including approximately 878,000 tests reported from its laboratory, compared to approximately 771,700 tests reported, including approximately 758,200 tests reported from its laboratory, in the fourth quarter of 2024, an increase of 15.6% from the prior period.
Total revenues were $2,306.1 million in the full year 2025 compared to $1,696.9 million in the full year 2024, an increase of 35.9%. The increase in total revenues was driven primarily by a 36.2% increase in product revenues, which were $2,295.8 million in the full year 2025 compared to $1,685.1 million in the full year 2024. The increase in product revenues was driven by an increase in volume and average selling price improvements.
Natera processed approximately 3,525,500 tests in the full year 2025, including approximately 3,468,700 tests accessioned in its laboratory, compared to approximately 3,064,600 tests processed, including approximately 3,001,900 tests accessioned in its laboratory, in the full year 2024.
In the full year 2025, Natera recognized revenue on approximately 3,342,500 tests for which results were reported to customers in the period (tests reported), including approximately 3,288,600 tests reported from its laboratory, compared to approximately 2,926,400 tests reported, including approximately 2,867,400 tests reported from its laboratory, in the full year 2024, an increase of 14.2% from the prior period.
Gross profit2 for the three months ended December 31, 2025 and 2024 was $445.2 million and $299.6 million, respectively, representing a gross margin1 of 66.9% and 62.9%, respectively. Gross profit1 for the year ended December 31, 2025 and 2024 was $1,493.2 million and $1,023.2 million, respectively, representing a gross margin1 of 64.7% and 60.3%, respectively. Natera had higher gross margin1 in the fourth quarter of 2025 and for the full year 2025 primarily as a result of higher revenues and continued progress in reducing cost of revenues associated with tests processed. Total operating expenses, representing research and development expenses and selling, general and administrative expenses, for the fourth quarter of 2025 was $466.5 million, compared to $364.4 million in the same period of the prior year, an increase of 28.0%. Total operating expense for the full year 2025 were $1,801.4 million, compared to $1,245.5 million in the same period of the prior year, an increase of 44.6%. The increases in both periods were primarily driven by headcount growth to support new product offerings as well as increases in consulting and legal expenses. Amortization of acquired intangible assets for the fourth quarter and full year of 2025 was $1.7 million. No such amortization occurred in the fourth quarter or full year of 2024.
Loss from operations for the fourth quarter of 2025 was $22.8 million compared to $64.7 million for the same period of the prior year. Loss from operations for full year 2025 was $309.9 million compared to $222.3 million for the same period of the prior year.
Natera’s net loss for the full year 2025 was $208.2 million, or ($1.52) per diluted share, compared to a net loss of $190.4 million, or ($1.53) per diluted share, in 2024. Weighted average shares outstanding were 136.7 million in the full year 2025 compared to 124.7 million for the same period in the prior year.
At December 31, 2025, Natera held approximately $1,076.1 million in cash, cash equivalents, short-term investments and restricted cash, compared to $968.3 million as of December 31, 2024. As of December 31, 2025, Natera had a total outstanding debt balance of $80.3 million including accrued interest under its line of credit with UBS at a variable interest rate of 30-day SOFR plus 50 bps.
Financial Outlook
Natera anticipates 2026 total revenue of $2.62 billion to $2.70 billion; 2026 gross margin1 to be approximately 63% to 65%; selling, general and administrative costs to be approximately $1.125 billion to $1.225 billion; research and development costs to be $750 million to $850 million; and net cash inflow to be positive3.
Test Volume Summary
Unit
Q4 2025
Q4 2024
FY 2025
FY 2024
Definition
Tests processed
923,600
792,800
3,525,500
3,064,600
Tests accessioned in our laboratory plus units processed outside of our laboratory
Tests accessioned
909,000
778,400
3,468,700
3,001,900
Test accessioned in our laboratory
Tests reported
892,400
771,700
3,342,500
2,926,400
Total tests reported
Tests reported in our laboratory
878,000
758,200
3,288,600
2,867,400
Total tests reported in our laboratory less units reported outside of our laboratory
About Natera
Natera™ is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 350 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. For more information, visit www.natera.com.
Conference Call Information
Event:
Natera’s Fourth Quarter and Full Year 2025 Financial Results Conference Call
Date:
Thursday, February 26, 2026
Time:
1:30 p.m. PT (4:30 p.m. ET)
Live Dial-In:
1-888-770-7321 (Domestic)
1-929-201-7107 (International)
Conference ID:
7684785
Webcast Link:
https://events.q4inc.com/attendee/730547572
Forward-Looking Statements
This press release contains forward-looking statements under the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts, including statements regarding our market opportunity, anticipated products and launch schedules, reimbursement coverage and product costs, commercial and strategic partnerships and acquisitions, user experience, clinical trials and studies, and our strategies, goals and general business and market conditions, are forward-looking statements. Any forward-looking statements contained in this press release are based upon Natera’s current plans, estimates, and expectations, as of the date of this release, and are not a representation that such plans, estimates, or expectations will be achieved.
These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including: we face numerous uncertainties and challenges in achieving our financial projections and goals; we may be unable to further increase the use and adoption of our products through our direct sales efforts or through our laboratory partners; we have incurred net losses since our inception and we anticipate that we will continue to incur net losses for the foreseeable future; our quarterly results may fluctuate from period to period; our estimates of market opportunity and forecasts of market growth may prove to be inaccurate; we may be unable to compete successfully with existing or future products or services offered by our competitors; we may engage in acquisitions, dispositions or other strategic transactions that may not achieve our anticipated benefits and could otherwise disrupt our business, cause dilution to our stockholders or reduce our financial resources; our products may not perform as expected; the results of our clinical studies may not support the use and reimbursement of our tests, particularly for microdeletions screening, and may not be able to be replicated in later studies required for regulatory approvals or clearances; if either of our primary CLIA-certified laboratories becomes inoperable, we will be unable to perform our tests and our business may be harmed; we rely on a limited number of suppliers or, in some cases, single suppliers, for some of our laboratory instruments and materials and may not be able to find replacements or immediately transition to alternative suppliers; if we are unable to successfully scale our operations, our business could suffer; the marketing, sale, and use of Panorama and our other products could result in substantial damages arising from product liability or professional liability claims that exceed our resources; we may be unable to expand, obtain or maintain third-party payer coverage and reimbursement for our tests, and we may be required to refund reimbursements already received; third-party payers may withdraw coverage or provide lower levels of reimbursement due to changing policies, billing complexities or other factors; we could incur substantial costs and delays complying with governmental regulations; litigation and other regulatory or governmental proceedings related to our intellectual property or the commercialization of our tests, are costly, time-consuming, could result in our obligation to pay material judgments or incur material settlement costs, and could limit our ability to commercialize our tests; and any inability to effectively protect our proprietary technology could harm our competitive position or our brand.
We discuss these and other risks and uncertainties in greater detail in the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our periodic reports on Forms 10-K and 10-Q and in other filings that we make with the SEC from time to time. These documents are available on our website at www.natera.com under the Investor Relations section and on the SEC’s website at www.sec.gov.
We operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. In light of these risks, uncertainties and assumptions, you should not place undue reliance on our forward-looking statements. Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this presentation to conform these statements to actual results or to changes in our expectations.
References:
Gross profit is calculated as GAAP total revenues less GAAP cost of revenues. Gross margin is calculated as gross profit divided by GAAP total revenues.
Positive cash inflow for the year ended December 31, 2025, is derived from the GAAP Statement of Cash Flows as follows: net cash provided by operating activities of $215.3 million, net cash provided by financing activities of $47.5 million, offset by net cash used in investing activities for purchases of property and equipment, cash paid for acquisition of intangible assets, and cash paid for business combination of $155.2 million.
Non-GAAP cash (outflow) inflow is calculated as the sum of GAAP net cash provided by (used in) operating activities, GAAP net cash provided by (used in) financing activities, and GAAP net cash provided by (used in) investing activities for purchases of property and equipment, investment in related party, cash paid for acquisition of intangible assets, and cash paid for business combination. Management uses non-GAAP cash flow as an indicator of the Company’s operational cash generating capabilities.
Natera, Inc.
Consolidated Balance Sheets
(Unaudited)
(in thousands, except shares)
December 31,
December 31,
2025
2024
(1)
Assets
Current assets:
Cash, cash equivalents and restricted cash
$
1,076,140
$
945,587
Short-term investments
—
22,689
Accounts receivable, net of allowance of $8,018 in 2025 and $7,259 in 2024
296,528
314,165
Inventory
68,443
44,744
Prepaid expenses and other current assets
55,828
48,635
Total current assets
1,496,939
1,375,820
Property and equipment, net
241,184
162,046
Operating lease right-of-use assets
108,541
86,149
Goodwill
141,070
—
Intangible assets
373,713
10,933
Other assets
36,897
25,787
Total assets
$
2,398,344
$
1,660,735
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$
33,156
$
34,922
Accrued compensation
92,603
62,114
Contingent consideration payable, current portion
21,580
—
Deferred revenue, current portion
24,907
19,754
Short-term debt financing
80,323
80,362
Other accrued liabilities
188,659
146,893
Total current liabilities
441,228
344,045
Contingent consideration payable, long-term portion
96,780
—
Deferred tax liability, long-term portion
701
—
Operating lease liabilities, long-term portion
118,473
96,588
Deferred revenue, long-term portion
17,062
16,838
Other liabilities
11,687
7,844
Total liabilities
685,931
465,315
Commitments and contingencies
Stockholders’ equity:
Common stock (2)
14
12
Additional paid in capital
4,488,679
3,763,614
Accumulated deficit
(2,776,022
)
(2,567,862
)
Accumulated other comprehensive loss
(258
)
(344
)
Total stockholders’ equity
1,712,413
1,195,420
Total liabilities and stockholders’ equity
$
2,398,344
$
1,660,735
(1)
The consolidated balance sheet at December 31, 2024 has been derived from the audited consolidated financial statements at that date included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.
(2)
As of December 31, 2025 and December 31, 2024, there were approximately 139,693,000 and 132,646,000 shares of common stock, respectively, issued and outstanding.
Natera, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(in thousands, except per share data)
Year ended December 31,
2025
2024
2023
Revenues
Product revenues
$
2,295,820
$
1,685,074
$
1,068,522
Licensing and other revenues
10,293
11,837
14,049
Total revenues
2,306,113
1,696,911
1,082,571
Cost and expenses
Cost of product revenues
810,627
672,304
588,564
Cost of licensing and other revenues
2,306
1,449
1,267
Research and development
624,110
404,138
320,678
Selling, general and administrative
1,177,261
841,314
618,307
Amortization of acquired intangible assets
1,720
—
—
Total cost and expenses
2,616,024
1,919,205
1,528,816
Loss from operations
(309,911
)
(222,294
)
(446,245
)
Interest expense
(4,069
)
(10,685
)
(12,638
)
Interest and other income, net
45,891
43,248
24,353
Loss before income taxes
(268,089
)
(189,731
)
(434,530
)
Income tax benefit (expense)
59,929
(695
)
(271
)
Net loss
$
(208,160
)
$
(190,426
)
$
(434,801
)
Unrealized gain on available-for-sale securities and foreign currency translation adjustment
86
2,741
13,277
Comprehensive loss
$
(208,074
)
$
(187,685
)
$
(421,524
)
Net loss per share:
Basic and diluted
$
(1.52
)
$
(1.53
)
$
(3.78
)
Weighted-average number of shares used in computing basic and diluted net loss per share:
Basic and diluted
136,721
124,718
114,997
View source version on businesswire.com: https://www.businesswire.com/news/home/20260226942327/en/
Investor Relations
Mike Brophy, CFO, Natera, Inc., 510-826-2350
Media
Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com
Original: Natera Reports Fourth Quarter and Full Year 2025 Financial Results
US Market News
4月前
Natera Launches EDEN Study on Early Risk Assessment for Preeclampsia and Adverse Pregnancy OutcomesFebruary 6, 2026 6:00 AM
Business Wire
Large prospective study to evaluate a non-invasive prenatal screening test
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced the launch of EDEN, a large, multi-center prospective study designed to evaluate the company’s non-invasive prenatal screening test for early risk assessment of preeclampsia and other serious pregnancy complications.
Preeclampsia affects approximately 5-8% of pregnancies and remains a leading cause of maternal and neonatal morbidity.1 While clinical guidelines recommend low-dose aspirin for patients with established risk factors for preeclampsia2, current risk assessment relies primarily on clinical characteristics and does not provide individualized estimates of risk or response to preventive strategies.3 More broadly, adverse pregnancy outcomes affect an estimated 20% of pregnancies in the United States and are associated with substantial maternal and fetal morbidity and mortality.4
EDEN is designed as a definitive prospective study of Natera’s integrated prenatal risk assessment test, which combines cell-free DNA (cfDNA), additional analytes and clinical data. The study plans to enroll up to 7,500 pregnant participants in the United States between 9 and 15 weeks’ gestation to evaluate risk for preeclampsia, including earlier-onset and more severe disease, along with additional adverse pregnancy outcomes.
Natera’s new test builds on previously published research demonstrating associations between cfDNA characteristics and adverse pregnancy outcomes. These studies showed that cfDNA-derived markers, when combined with patient characteristics, can identify risk for preeclampsia with performance comparable to approaches that rely on specialized imaging or additional biomarkers, and that nonreportable cfDNA results are associated with increased risk of pregnancy complications.5,6
“For more than a decade, Natera has advanced pregnancy care through highly sensitive, non-invasive testing,” said Sheetal Parmar, senior vice president of medical affairs at Natera. “With EDEN, we are evaluating a next-generation test designed to identify pregnancies at increased risk for preeclampsia and other serious complications earlier and with greater precision, using data that are already part of routine prenatal care.”
References
Johns Hopkins Medicine. Preeclampsia: https://www.hopkinsmedicine.org/health/conditions-and-diseases/preeclampsia. Accessed February 2026.
U.S. Preventive Services Task Force. Aspirin use to prevent preeclampsia and related morbidity and mortality: US Preventive Services Task Force recommendation statement. JAMA. 2017;317(16):1661–1667. doi:10.1001/jama.2017.3439
O’Gorman N, Wright D, Poon LC, et al. Multicenter screening for preeclampsia by maternal factors and biomarkers at 11–13 weeks’ gestation: comparison with NICE guidelines and ACOG recommendations. Ultrasound Obstet Gynecol. 2017;49(6):756–760. doi:10.1002/uog.17399
Khan F, et al. Adverse pregnancy outcomes, including hypertensive disorders, low birthweight, and preterm birth, now complicate nearly 1 in 5 live births in the United States. Curr Opin Obstet Gynecol. 2023.
Khalil A, Bellesia G, Norton ME, et al. The role of cell-free DNA biomarkers and patient data in the early prediction of preeclampsia: an artificial intelligence model. Am J Obstet Gynecol. 2024;231(5):554.e1-554.e18. doi:10.1016/j.ajog.2024.02.299
Norton ME, MacPherson C, Demko Z, et al. Obstetrical, perinatal, and genetic outcomes associated with nonreportable prenatal cell-free DNA screening results. Am J Obstet Gynecol. 2023;229(3):300.e1-300.e9. doi:10.1016/j.ajog.2023.03.026
About Natera
Natera™ is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 350 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. For more information, visit www.natera.com.
Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260206350770/en/
Investor Relations: Mike Brophy, CFO, Natera, Inc., investor@natera.com
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com
Original: Natera Launches EDEN Study on Early Risk Assessment for Preeclampsia and Adverse Pregnancy Outcomes
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