Latest news with #Signatera
Yahoo
22-05-2025
- Business
- Yahoo
Natera to Present over 25 Signatera™ Studies at 2025 ASCO Annual Meeting
Studies include nearly 25,000 patients across multiple indications, showcasing the clinical impact of Signatera Breast: 8 accepted abstracts (4 oral presentations), including interim analysis from the randomized Signatera-guided interventional DARE trial; a large real-world study of metastatic treatment monitoring; and two readouts from the ISPY-2 trial Signatera Genome: Large-scale, pan-cancer performance of Signatera Genome assay GI, GU, Skin, Sarcoma: Significance of Signatera MRD and dynamics to predict recurrence, progression, and treatment response across multiple disease subtypes AUSTIN, Texas, May 22, 2025--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that data from more than 25 Signatera studies will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 30 - June 3, 2025 in Chicago, IL. Together with its collaborators, Natera will showcase the clinical utility of Signatera across 10 different cancer types. This extraordinary breadth of data includes analyses of thousands of patients, demonstrating Natera's leadership in circulating tumor DNA (ctDNA) monitoring and molecular residual disease (MRD) assessment. "The depth and breadth of Natera's research at ASCO is our most significant to date, with multiple impactful datasets in several histologies," said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology at Natera. "The interim analysis from the DARE trial shows a possible first signal in a randomized setting that treating high-risk breast cancer patients based on Signatera results can impact clearance rates. We also look forward to sharing results on our ultra-sensitive Signatera Genome assay, along with numerous other presentations underscoring our commitment to advance the way cancer is managed." Highlights include: DARE Clinical Trial: Oral Presentation DARE is a prospective, randomized study, launched in 2021, to investigate the utility of Signatera for guiding adjuvant endocrine therapy in 585 women with high-risk, estrogen receptor-positive, HER2-negative (ER+/HER2-) breast cancer. It assesses the novel concept of "treatment on molecular recurrence" (TOMR). Patients who were Signatera-positive and imaging-negative were randomized into two arms: the standard-of-care (SOC) arm with endocrine therapy vs. the escalated arm with fulvestrant+palbociclib (CDK 4/6i). This interim analysis of 507 women and 2,208 plasma samples demonstrates the exceptional clinical performance of Signatera, and the early feasibility of both this treatment escalation approach and the TOMR trial strategy, including: Strong test sensitivity and NPV: Among patients who remained persistently Signatera-negative during screening (>400 pts), 99% remained recurrence free with a median follow up of 27.4 months. High randomization rate: Of patients who tested Signatera-positive, 73% were negative on imaging, and 93% were willing to be randomized. 2x higher ctDNA clearance: Patients in Arm A had a 2x higher rate of ctDNA clearance at 3 months vs. Arm B. Signatera Monitoring in Metastatic Breast Cancer: Oral Presentation This real-world analysis of over 600 metastatic breast cancer (mBC) patients across all disease subtypes and a wide range of therapeutic regimens (e.g., chemo, ADCs, CDK4/6) shows the utility of metastatic monitoring with Signatera: Serial ctDNA testing done at an appropriate cadence (6 weeks) can inform treatment response and clinical decisions in metastatic breast cancer. Signatera ctDNA dynamics were the strongest predictor of treatment benefit in a multivariate analysis, based on measuring time to next treatment (TTNT). Nearly 75% of patients with favorable dynamics remained on the same treatment for over 4 months, including those receiving antibody drug conjugates (ADCs) where therapy response can be challenging to evaluate on imaging. Pan-Cancer Performance of Signatera Genome: Poster Presentation Large-scale presentation of Signatera's Genome assay, analyzing more than 3,000 samples from over 300 patients across 5 major cancer types. The study includes analysis of patients with breast cancer, colorectal cancer, non-small cell lung cancer, melanoma, and renal cell carcinoma. Signatera Performance in Post-Surgical Stage I-IIIb Melanoma: Poster Presentation This study includes 197 patients and 1,681 plasma samples, tested for a median period of 2 years. This is one of the most comprehensive MRD/monitoring datasets thus far in early melanoma, demonstrating the ability of Signatera to identify patients who may benefit from escalated imaging or earlier treatment initiation. Post-surgical Signatera-positivity was the most significant predictor of recurrence free survival (RFS). In the surveillance setting, Signatera-positivity was predictive of shorter RFS (HR: 24.0, P < 0.001). Full list of oral presentations at ASCO: May 30, 2:45 PM CT | 3008 | BreastPresenter: Silver AlkhafajiCirculating tumor DNA (ctDNA) in patients with stage 2/3 HR+HER2-negative breast cancer (BC) treated with neoadjuvant endocrine therapy (NET) in the I-SPY2 endocrine optimization pilot (EOP) trial June 1, 9:45 AM CT | 4503 | GenitourinaryPresenter: Thomas Powles, MBBS, MRCP, tumor DNA (ctDNA) in patients with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA June 1, 11:30 AM CT | 3518 | GastrointestinalPresenter: Aron Bercz, Tumor DNA Provides an Early Response Assessment in Anal Squamous Cell Carcinoma Treated With Definitive Chemoradiation June 1, 4:30 PM CT | 1010 | BreastPresenter: Lajos Pusztai, M.D., DPhilCirculating tumor (ct)DNA monitoring of ER+/HER2- high-risk breast cancer (BC) during adjuvant endocrine therapy (ET) (DARE) June 1, 4:30 PM CT | 1011 | BreastPresenter: Pedram Razavi, M.D., tumor DNA (ctDNA) dynamics as a predictor of treatment response in metastatic breast cancer (mBC) June 2, 3:00 PM CT | 504 | BreastPresenter: Rita Mukhtar, nodal burden after neoadjuvant chemotherapy (NAC) with circulating tumor (ct)DNA for surgical planning: Results from the I-SPY2 trial Full list of poster presentations at ASCO: May 31, 9:00 AM CT | 11537 | SarcomaPresenter: Adie Victor, M.D., on-treatment circulating tumor (ct)DNA dynamics in response to therapy in patients with sarcoma May 31, 9:00 AM CT | 11531 | SarcomaPresenter: Maggie Zhou, assessment of response to chemotherapy via ctDNA in soft tissue sarcoma May 31, 9:00 AM CT | TPS3647 | GastrointestinalPresenter: Clara Montagut, M.D.A precision medicine trial leveraging tissue and blood-based tumor genomics to optimize treatment in resected stage III and high-risk stage II colon cancer (CC) patients (pts): The SAGITTARIUS Trial. May 31, 9:00 AM CT | 4067 | Gastrointestinal - FMIPresenter: Michele Prisciandaro, liquid biopsy in predicting recurrence in patients with operable gastroesophageal adenocarcinoma: the LIQUID study May 31, 9:00 AM CT | 4130 | GastrointestinalPresenter: Maen Abdelrahim, analysis of ctDNA and other biomarkers in patients with curatively resected Stage I-III Biliary Tract Cancer May 31, 9:00 AM CT | 3600 | GastrointestinalPresenter: Eiji Oki, of Perioperative Complications on ctDNA-based MRD Detection and Prognosis: Insights from the GALAXY Study May 31, 9:00 AM CT | 3591 | GastrointestinalPresenter: Emerik Osterlund, M.D., correlates of circulating tumor DNA (ctDNA) shedding in the INTERCEPT colorectal cancer (CRC) study May 31, 9:00 AM CT | 3597 | ColorectalPresenter: Midhun Malla, M.D., dynamics and targeted therapies associated with genetic mutations in patients with colorectal cancer May 31, 9:00 AM CT | 4073 | Esophagogastric GastricPresenter: Reetu Mukherji, analysis of over 5000 esophagogastric cancers June 1, 9:00 AM CT | 9574 | Merkel Cell CarcinomaPresenter: Joshua Elbridge ChanComparison of surveillance circulating tumor DNA and merkel polyomavirus antibody titer for detection of merkel cell carcinoma recurrence June 1, 9:00 AM CT | 9571 | MelanomaPresenter: George Ansstas, ctDNA monitoring for post-surgical molecular residual disease in patients with stage I-IIIb melanoma June 1, 9:00 AM CT | 9523 | MelanomaPresenter: Caroline BurkeyCirculating tumor DNA (ctDNA) dynamics during anti-PD-1 based therapy to predict clinical outcomes in advanced stage melanoma: A multicenter retrospective study. June 1, 9:00 AM CT | 9584 | MelanomaPresenter: Vincent The-Luc MaSensitivity of circulating tumor DNA (ctDNA) for disease recurrence or relapse in melanoma patients June 1, 9:00 AM CT | 5563 | GynecologicalPresenter: Jung-Yun Lee, M.D., monitoring in participants with ovarian cancer treated with neoadjuvant pembrolizumab (pembro) plus chemotherapy (chemo) with or without the anti–immunoglobulin-like transcript 4 (ILT4) monoclonal antibody MK-4830 June 2, 9:00 AM CT | 4565 | GenitourinaryPresenter: Adanma Ayanambakkam, of Tumor-Informed ctDNA-based Molecular Residual Disease (MRD) with Clinical Outcomes for Upper Tract Urothelial Cancer (UTUC) June 2, 9:00 AM CT | 4602 | GenitourinaryPresenter: Ilana EpsteinCorrelation of circulating tumor DNA (ctDNA) dynamics with clinical response in muscle-invasive bladder cancer (MIBC) patients (pts) undergoing trimodality therapy (TMT) June 2, 9:00 AM CT | 4560 | GenitourinaryPresenter: Kevin R. Reyes, BSCirculating tumor DNA (ctDNA) monitoring in patients (pts) with advanced urothelial carcinoma (aUC) treated with Enfortumab Vedotin +/- Pembrolizumab (EVP) June 2, 9:00 AM CT | TPS620 | BreastPresenter: Michail Ignatiadis, M.D., Elacestrant for treating ER+/HER2- breast cancer patients with ctDNA relapse (TREAT ctDNA) June 2, 9:00 AM CT | 581 | BreastPresenter: Julia Foldi, M.D., circulating tumor DNA (ctDNA) monitoring in early-stage, HR+/HER2-, invasive lobular carcinoma (ILC) of the breast and impact on clinical outcomes June 2, 9:00 AM CT | 560 | BreastPresenter: Marla Lipsyc-Sharf, of circulating tumor DNA (ctDNA) testing for molecular surveillance in early-stage breast cancer (eBC) June 2, 9:00 AM CT | 612 | BreastPresenter: Mei Wei, M.D.I-SPY2 endocrine optimization pilot (EOP): Neoadjuvant lasofoxifene (Laso) in molecularly selected patients with hormone receptor positive (HR+)/HER2 negative (HER2-) stage 2/3 breast cancer (BC) June 2, 1:30 PM CT | 3142 | PancancerPresenter: Mridula George, performance of Signatera Genome assay in a cohort of patients (pts) with solid tumors June 2, 1:30 PM CT | 3048 | GastrointestinalPresenter: John Paul Y.C. Shen, of a methylation-based, tissue-free test for the detection of molecular residual disease by circulating tumor DNA About Signatera Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and has coverage by Medicare across a broad range of indications. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 100 peer-reviewed papers. About Natera Natera™ is a global leader in cell-free DNA and genetic testing, 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 250 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. For more information, visit 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 and View source version on Contacts Investor Relations: Mike Brophy, CFO, Natera, Inc., investor@ Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
22-05-2025
- Business
- Business Wire
Natera to Present over 25 Signatera™ Studies at 2025 ASCO Annual Meeting
AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that data from more than 25 Signatera studies will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 30 - June 3, 2025 in Chicago, IL. Together with its collaborators, Natera will showcase the clinical utility of Signatera across 10 different cancer types. This extraordinary breadth of data includes analyses of thousands of patients, demonstrating Natera's leadership in circulating tumor DNA (ctDNA) monitoring and molecular residual disease (MRD) assessment. 'The depth and breadth of Natera's research at ASCO is our most significant to date, with multiple impactful datasets in several histologies,' said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology at Natera. 'The interim analysis from the DARE trial shows a possible first signal in a randomized setting that treating high-risk breast cancer patients based on Signatera results can impact clearance rates. We also look forward to sharing results on our ultra-sensitive Signatera Genome assay, along with numerous other presentations underscoring our commitment to advance the way cancer is managed.' Highlights include: DARE Clinical Trial: Oral Presentation DARE is a prospective, randomized study, launched in 2021, to investigate the utility of Signatera for guiding adjuvant endocrine therapy in 585 women with high-risk, estrogen receptor-positive, HER2-negative (ER+/HER2-) breast cancer. It assesses the novel concept of 'treatment on molecular recurrence' (TOMR). Patients who were Signatera-positive and imaging-negative were randomized into two arms: the standard-of-care (SOC) arm with endocrine therapy vs. the escalated arm with fulvestrant+palbociclib (CDK 4/6i). This interim analysis of 507 women and 2,208 plasma samples demonstrates the exceptional clinical performance of Signatera, and the early feasibility of both this treatment escalation approach and the TOMR trial strategy, including: Strong test sensitivity and NPV: Among patients who remained persistently Signatera-negative during screening (>400 pts), 99% remained recurrence free with a median follow up of 27.4 months. High randomization rate: Of patients who tested Signatera-positive, 73% were negative on imaging, and 93% were willing to be randomized. 2x higher ctDNA clearance: Patients in Arm A had a 2x higher rate of ctDNA clearance at 3 months vs. Arm B. Signatera Monitoring in Metastatic Breast Cancer: Oral Presentation This real-world analysis of over 600 metastatic breast cancer (mBC) patients across all disease subtypes and a wide range of therapeutic regimens (e.g., chemo, ADCs, CDK4/6) shows the utility of metastatic monitoring with Signatera: Serial ctDNA testing done at an appropriate cadence (6 weeks) can inform treatment response and clinical decisions in metastatic breast cancer. Signatera ctDNA dynamics were the strongest predictor of treatment benefit in a multivariate analysis, based on measuring time to next treatment (TTNT). Nearly 75% of patients with favorable dynamics remained on the same treatment for over 4 months, including those receiving antibody drug conjugates (ADCs) where therapy response can be challenging to evaluate on imaging. Pan-Cancer Performance of Signatera Genome: Poster Presentation Large-scale presentation of Signatera's Genome assay, analyzing more than 3,000 samples from over 300 patients across 5 major cancer types. The study includes analysis of patients with breast cancer, colorectal cancer, non-small cell lung cancer, melanoma, and renal cell carcinoma. Signatera Performance in Post-Surgical Stage I-IIIb Melanoma: Poster Presentation This study includes 197 patients and 1,681 plasma samples, tested for a median period of 2 years. This is one of the most comprehensive MRD/monitoring datasets thus far in early melanoma, demonstrating the ability of Signatera to identify patients who may benefit from escalated imaging or earlier treatment initiation. Post-surgical Signatera-positivity was the most significant predictor of recurrence free survival (RFS). In the surveillance setting, Signatera-positivity was predictive of shorter RFS (HR: 24.0, P < 0.001). Full list of oral presentations at ASCO: May 30, 2:45 PM CT | 3008 | Breast Presenter: Silver Alkhafaji Circulating tumor DNA (ctDNA) in patients with stage 2/3 HR+HER2-negative breast cancer (BC) treated with neoadjuvant endocrine therapy (NET) in the I-SPY2 endocrine optimization pilot (EOP) trial June 1, 9:45 AM CT | 4503 | Genitourinary Presenter: Thomas Powles, MBBS, MRCP, M.D. Circulating tumor DNA (ctDNA) in patients with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA June 1, 11:30 AM CT | 3518 | Gastrointestinal Presenter: Aron Bercz, M.D. Circulating Tumor DNA Provides an Early Response Assessment in Anal Squamous Cell Carcinoma Treated With Definitive Chemoradiation June 1, 4:30 PM CT | 1010 | Breast Presenter: Lajos Pusztai, M.D., DPhil Circulating tumor (ct)DNA monitoring of ER+/HER2- high-risk breast cancer (BC) during adjuvant endocrine therapy (ET) (DARE) June 1, 4:30 PM CT | 1011 | Breast Presenter: Pedram Razavi, M.D., Ph.D. Circulating tumor DNA (ctDNA) dynamics as a predictor of treatment response in metastatic breast cancer (mBC) June 2, 3:00 PM CT | 504 | Breast Presenter: Rita Mukhtar, M.D. Predicting nodal burden after neoadjuvant chemotherapy (NAC) with circulating tumor (ct)DNA for surgical planning: Results from the I-SPY2 trial Full list of poster presentations at ASCO: May 31, 9:00 AM CT | 11537 | Sarcoma Presenter: Adie Victor, M.D., M.S. Early on-treatment circulating tumor (ct)DNA dynamics in response to therapy in patients with sarcoma May 31, 9:00 AM CT | 11531 | Sarcoma Presenter: Maggie Zhou, M.D. Early assessment of response to chemotherapy via ctDNA in soft tissue sarcoma May 31, 9:00 AM CT | TPS3647 | Gastrointestinal Presenter: Clara Montagut, M.D. A precision medicine trial leveraging tissue and blood-based tumor genomics to optimize treatment in resected stage III and high-risk stage II colon cancer (CC) patients (pts): The SAGITTARIUS Trial. May 31, 9:00 AM CT | 4067 | Gastrointestinal - FMI Presenter: Michele Prisciandaro, M.D. Tumor-informed liquid biopsy in predicting recurrence in patients with operable gastroesophageal adenocarcinoma: the LIQUID study May 31, 9:00 AM CT | 4130 | Gastrointestinal Presenter: Maen Abdelrahim, M.D. Real-world analysis of ctDNA and other biomarkers in patients with curatively resected Stage I-III Biliary Tract Cancer May 31, 9:00 AM CT | 3600 | Gastrointestinal Presenter: Eiji Oki, Ph.D. Impact of Perioperative Complications on ctDNA-based MRD Detection and Prognosis: Insights from the GALAXY Study May 31, 9:00 AM CT | 3591 | Gastrointestinal Presenter: Emerik Osterlund, M.D., Ph.D. Biologic correlates of circulating tumor DNA (ctDNA) shedding in the INTERCEPT colorectal cancer (CRC) study May 31, 9:00 AM CT | 3597 | Colorectal Presenter: Midhun Malla, M.D., M.S. ctDNA dynamics and targeted therapies associated with genetic mutations in patients with colorectal cancer May 31, 9:00 AM CT | 4073 | Esophagogastric Gastric Presenter: Reetu Mukherji, M.D. Exome analysis of over 5000 esophagogastric cancers June 1, 9:00 AM CT | 9574 | Merkel Cell Carcinoma Presenter: Joshua Elbridge Chan Comparison of surveillance circulating tumor DNA and merkel polyomavirus antibody titer for detection of merkel cell carcinoma recurrence June 1, 9:00 AM CT | 9571 | Melanoma Presenter: George Ansstas, M.D. Longitudinal ctDNA monitoring for post-surgical molecular residual disease in patients with stage I-IIIb melanoma June 1, 9:00 AM CT | 9523 | Melanoma Presenter: Caroline Burkey Circulating tumor DNA (ctDNA) dynamics during anti-PD-1 based therapy to predict clinical outcomes in advanced stage melanoma: A multicenter retrospective study. June 1, 9:00 AM CT | 9584 | Melanoma Presenter: Vincent The-Luc Ma Sensitivity of circulating tumor DNA (ctDNA) for disease recurrence or relapse in melanoma patients June 1, 9:00 AM CT | 5563 | Gynecological Presenter: Jung-Yun Lee, M.D., Ph.D. ctDNA monitoring in participants with ovarian cancer treated with neoadjuvant pembrolizumab (pembro) plus chemotherapy (chemo) with or without the anti–immunoglobulin-like transcript 4 (ILT4) monoclonal antibody MK-4830 June 2, 9:00 AM CT | 4565 | Genitourinary Presenter: Adanma Ayanambakkam, M.D. Association of Tumor-Informed ctDNA-based Molecular Residual Disease (MRD) with Clinical Outcomes for Upper Tract Urothelial Cancer (UTUC) June 2, 9:00 AM CT | 4602 | Genitourinary Presenter: Ilana Epstein Correlation of circulating tumor DNA (ctDNA) dynamics with clinical response in muscle-invasive bladder cancer (MIBC) patients (pts) undergoing trimodality therapy (TMT) June 2, 9:00 AM CT | 4560 | Genitourinary Presenter: Kevin R. Reyes, BS Circulating tumor DNA (ctDNA) monitoring in patients (pts) with advanced urothelial carcinoma (aUC) treated with Enfortumab Vedotin +/- Pembrolizumab (EVP) June 2, 9:00 AM CT | TPS620 | Breast Presenter: Michail Ignatiadis, M.D., Ph.D. EORTC-2129-BCG: Elacestrant for treating ER+/HER2- breast cancer patients with ctDNA relapse (TREAT ctDNA) June 2, 9:00 AM CT | 581 | Breast Presenter: Julia Foldi, M.D., Ph.D. Serial circulating tumor DNA (ctDNA) monitoring in early-stage, HR+/HER2-, invasive lobular carcinoma (ILC) of the breast and impact on clinical outcomes June 2, 9:00 AM CT | 560 | Breast Presenter: Marla Lipsyc-Sharf, M.D. Cadence of circulating tumor DNA (ctDNA) testing for molecular surveillance in early-stage breast cancer (eBC) June 2, 9:00 AM CT | 612 | Breast Presenter: Mei Wei, M.D. I-SPY2 endocrine optimization pilot (EOP): Neoadjuvant lasofoxifene (Laso) in molecularly selected patients with hormone receptor positive (HR+)/HER2 negative (HER2-) stage 2/3 breast cancer (BC) June 2, 1:30 PM CT | 3142 | Pancancer Presenter: Mridula George, M.D. Clinical performance of Signatera Genome assay in a cohort of patients (pts) with solid tumors June 2, 1:30 PM CT | 3048 | Gastrointestinal Presenter: John Paul Y.C. Shen, M.D. Development of a methylation-based, tissue-free test for the detection of molecular residual disease by circulating tumor DNA About Signatera Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and has coverage by Medicare across a broad range of indications. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 100 peer-reviewed papers. About Natera Natera™ is a global leader in cell-free DNA and genetic testing, 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 250 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. For more information, visit 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 and
Yahoo
13-05-2025
- Business
- Yahoo
Natera, Inc. (NTRA): A Bull Case Theory
We came across a bullish thesis on Natera, Inc. (NTRA) on Substack by FJ Research. In this article, we will summarize the bulls' thesis on NTRA. Natera, Inc. (NTRA)'s share was trading at $162.57 as of May 8th. A doctor in a medical laboratory wearing a protective suit and a face mask, running a molecular diagnostic test. Natera is emerging as one of the most pivotal companies in the transformation of global healthcare, and its significance has not gone unnoticed by legendary investor Stanley Druckenmiller—who has made it his largest position. Known for his nearly unmatched track record, including 30%+ annual returns over decades and prescient bets on tech, AI, and energy, Druckenmiller only invests his own capital and swings hard when the upside far outweighs the risk. His conviction in Natera is a signal worth paying close attention to. When someone with his foresight and discipline makes such a concentrated bet, it suggests the company's long-term potential may be vastly underappreciated by the broader market. Natera specializes in non-invasive, DNA-based diagnostic testing with a mission to shift healthcare from reactive treatment to proactive detection. Its key platforms—Signatera™ for monitoring cancer recurrence, Prospera™ for transplant rejection, and Panorama™ for prenatal screening—are category-defining technologies. These aren't incremental improvements; they're transformative solutions targeting massive, underserved markets. Signatera leads in the fast-growing minimal residual disease (MRD) space, helping detect cancer recurrence earlier than traditional methods. Prospera offers real-time organ transplant health monitoring, while Panorama is already widely used in prenatal care. Together, these platforms could reshape how millions are diagnosed and treated. The company is growing rapidly, backed by years of research and clinical validation. Natera's diagnostics are gaining traction in mainstream medical practice, and institutional confidence is high—early backing from Sequoia Capital reinforces its credibility. Beyond technology, Natera's founding story adds emotional weight to its mission. Founder Matthew Rabinowitz launched the company after losing a family member to a preventable genetic condition, fueling his drive to bring early detection into the medical mainstream. That personal origin is reflected in the company's culture and long-term vision. Despite operating in a highly technical and regulated industry, Natera's business is increasingly about inevitability. AI and computational biology are finally disrupting healthcare, and Natera is at the center of this shift. The company's addressable market is vast, especially in oncology, where early detection can dramatically improve outcomes and lower costs. For investors, this represents a rare opportunity: a company with real-world impact, strong growth, deep competitive moats, and the endorsement of one of the greatest investors of our time. Druckenmiller's high-conviction bet highlights what's at stake—and why Natera may be one of the most essential and undervalued healthcare companies of the next decade. Natera, Inc. (NTRA) is not on our list of the 30 Most Popular Stocks Among Hedge Funds. As per our database, 77 hedge fund portfolios held NTRA at the end of the fourth quarter which was 62 in the previous quarter. While we acknowledge the risk and potential of NTRA as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns, and doing so within a shorter timeframe. If you are looking for an AI stock that is more promising than NTRA but that trades at less than 5 times its earnings, check out our report about the cheapest AI stock. READ NEXT: 8 Best Wide Moat Stocks to Buy Now and 30 Most Important AI Stocks According to BlackRock. Disclosure: None. This article was originally published at Insider Monkey.
Business Wire
08-05-2025
- Health
- Business Wire
Signatera Data From I-SPY 2 Trial to Be Presented at ESMO Breast Annual Congress
AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, will present multiple datasets in breast cancer together with its collaborators at the 2025 ESMO Breast Cancer Annual Congress in Munich, Germany, taking place from May 14-17, 2025. Results from the I-SPY 2 clinical trial, sponsored and operated by Quantum Leap Healthcare Collaborative, will be shared in a mini-oral presentation on May 16, 2025. The report includes data from 712 patients with early-stage, high-risk breast cancer, and it evaluates the association of distant recurrence free survival (DRFS) with ctDNA concentration at diagnosis, before receiving neoadjuvant systemic therapy and curative-intent surgery. Key highlights include: Signatera positive patients at diagnosis had 3x higher risk of recurrence than Signatera negative patients (HR 3.1, p< 0.001%), though the risk can be significantly reduced based on response to subsequent therapy. Patients who were Signatera negative at diagnosis had extremely good outcomes. Among patients who were Signatera positive at diagnosis, higher ctDNA quantities at the time of diagnosis were significantly correlated with a higher risk of recurrence. However, effective treatment can affect ctDNA levels as well as pathologic response status, both of which further refine risk of recurrence. This is the first time that pre-treatment absolute ctDNA quantity has been shown to correlate with clinical outcomes in breast cancer. Among all clinicopathologic risk factors available at diagnosis, a multivariate analysis identified Signatera status as the most significant factor in predicting DRFS, regardless of disease subtype (p<0.001). DRFS prediction can be further refined by integrating additional variables before, during, and after treatment, including ctDNA dynamics. 'The I-SPY 2 trial is uncovering insights that may allow us to tailor treatment plans for breast cancer patients based on their individual genomic profiles and better identify patients who may be more likely to experience adverse outcomes,' said Laura Esserman, M.D., MBA, and Laura van 't Veer, Ph.D., professors at the University of California, San Francisco, and principal investigators of the I-SPY 2 study. 'Our hope is that these findings will encourage future interventional trials in breast cancer, specifically in the neoadjuvant setting.' 'Signatera was able to predict excellent clinical outcomes in a high risk population at the time of diagnosis,' said Angel Rodriguez, M.D., medical director, oncology at Natera. 'This may give rise to new protocols, evaluating whether some patients can avoid chemotherapy or other intensive treatments, if they test Signatera-negative at diagnosis.' Natera will present an additional three abstracts at the ESMO Breast conference, highlighting real-world evidence and genomic landscaping from its multi-modal database of de-identified clinical and genomic data in over 200,000 early- and late-stage cancer patients. Full list of Natera's ESMO Breast presentations: May 16, 9:40 AM CT | FPN 5MO Presenter: Mark Magbanua, Ph.D., UCSF Helen Diller Family Comprehensive Cancer Center Pretreatment Circulating Tumor (ct)DNA Predicts Metastatic Recurrence in Patients (pts) With High-Risk Early Breast Cancer (eBC) Enrolled in the I-SPY 2 Trial May 15, 12:00 PM CT | FPN 115P Presenter: Chu-Ling Yu, Merck Real-World Testing Patterns of Circulating Tumor DNA (ctDNA) in Early-Stage Triple-Negative Breast Cancer (TNBC): a U.S. Nationwide Database Study May 15, 12:00 PM CT | FPN 12P Presenter: Melinda Telli, M.D., Stanford University School of Medicine Real-world experience of longitudinal circulating tumor (ct)DNA monitoring in patients (pts) with early-stage triple-negative breast cancer (TNBC) May 15, 12:00 PM CT | FPN 412TiP Presenter: Thibault De La Motte Rouge, M.D., Ph.D., Comprehensive Cancer Centre Eugène Marquis (Rennes, France) HEROES: De-escalation of medical therapies in HER2-positive metastatic breast cancer in long-term persistent response and minimal residual disease undetectable in circulating tumor DNA May 15, 12:00 PM CT | FPN 37P Presenter: Marla Lipsyc-Sharf, M.D., UCLA Health Genetic Ancestry and Tumor Mutations Influence Circulating Tumor DNA (ctDNA) Detection Rates in Breast Cancer: A Large Real-World Study May 15, 12:00 PM CT | FPN 93P Presenter: Yara Abdou, M.D., UNC School of Medicine Assessment of antibody-drug conjugate utilization in patients with breast cancer undergoing circulating tumor DNA testing About Signatera Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and has coverage by Medicare across a broad range of indications. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 100 peer-reviewed papers. About Natera Natera™ is a global leader in cell-free DNA and genetic testing, 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 250 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. For more information, visit 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 and
Medscape
06-05-2025
- Health
- Medscape
ctDNA Positivity in CRC Links to Chemotherapy Response
SAN DIEGO — Molecular residual disease (MRD) positivity, as detected via circulating tumor (ct) DNA following curative resection, was significantly associated with improved disease-free survival after chemotherapy in patients with stage II or III colorectal cancer (CRC), the results of the BESPOKE study showed. 'These findings highlight the value of utilizing ctDNA to select which patients should receive management chemotherapy and which patients can be potentially spared chemotherapy's physical, emotional, and financial toxicities without compromising their long-term outcomes,' said first author Kim Magee, of Natera, Inc., in Austin, Texas. 'ctDNA is emerging as the most powerful and prognostic biomarker in colorectal cancer,' said Magee, who presented the findings at Digestive Disease Week (DDW) 2025. In stage II CRC, as many as 80% of patients are cured by surgery alone, while only about 5% benefit from chemotherapy. In stage III CRC, about half of patients are cured by surgery alone, while only 20% benefit from chemotherapy, and 30% recur despite chemotherapy, Magee explained. The inability to pinpoint which patients will most benefit from chemotherapy means 'we know we are needlessly treating [many] of these patients,' she said. ctDNA Offers Insights Into Tumor's Real-Time Status Just as cells release fragments (cell-free DNA) into the blood as they regenerate, tumor cells also release fragments — ctDNA — which can represent a biomarker of a cancer's current state, Magee explained. Because the DNA fragments have a half-life of only about 2 hours, they represent a key snapshot in real time, 'as opposed to imaging, which can take several weeks or months to show changes,' she said. To determine the effects of ctDNA testing on treatment decisions and asymptomatic recurrence rates, Magee and colleagues analyzed data from the multicenter, prospective study, which used the Signatera (Natera, Inc.) residual disease test. The study included 1794 patients with resected stage II-III CRC who were treated with the standard of care between May 2020 and March 2023 who had complete clinical and laboratory data available. ctDNA was collected 2-6 weeks post-surgery and at surveillance months 2, 4, 6, and every 3 months through month 24. Among the 1166 patients included in a final analysis, 694 (59.5%) patients received adjunctive chemotherapy, and 472 (40.5%) received no chemotherapy. Among those with stage II CRC, a postoperative MRD positivity rate was 7.54%, while the rate in those with stage III disease was 28.35%. Overall, 16.1% of patients had a recurrence by the trial end at 24 months. The results showed that among patients who tested negative for ctDNA, the disease-free survival estimates were highly favorable, at 91.8% for stage II and 87.4% for stage III CRC. Comparatively, for those who were ctDNA-positive, disease-free survival rates were just 45.9% and 35.5%, respectively, regardless of whether those patients received adjunctive chemotherapy. At the study's first ctDNA surveillance timepoint, patients who were ctDNA-positive with stage II and III CRC combined had substantially worse disease-free survival than patients who were ctDNA-negative (HR, 26.4; P < .0001). Impact of Chemotherapy Patients who were found to be MRD-positive on ctDNA testing and treated with chemotherapy had a 40.3% 2-year disease-free survival rate compared with just 24.7% among patients with MRD-positive who did not receive chemotherapy. Meanwhile, those who were MRD-negative and treated with chemotherapy had a substantially higher 2-year disease-free survival rate of 89.7% — nearly identical to the 89.5% observed in the no-chemotherapy group. The findings underscored that 'the adjuvant chemotherapy benefits were only observed among those who were ctDNA-positive,' Magee said. 'ctDNA can guide postsurgical treatment decisions by identifying which patients are most likely to benefit from chemotherapy, and in the surveillance setting, ctDNA can predict recurrence — usually ahead of scans,' she added. 'This opens the opportunity to intervene and give those patients a second chance at cure.' On the heels of major recent advances including CT, MRI, and PET-CT, 'we believe that ctDNA represents the next major pivotal advancement in monitoring and eventually better understanding cancer diagnostics,' Magee said. Commenting on the study, William M. Grady, MD, medical director of the Fred Hutchinson Cancer Center Gastrointestinal Cancer Prevention Clinic in Seattle, said the BESPOKE trial represents a 'well-done' study, adding to research underscoring that 'MRD testing is a more accurate prognostic assay than the current standards of CT scan and CEA (carcinoembryonic antigen, a tumor marker) testing.' However, 'a limitation is that this is 2 years of follow-up, [while] 5-year follow-up data would be ideal,' he told Medscape Medical News , noting, importantly, that 'a small number of patients who have no evidence of disease (NED) at 2 years develop recurrence by 5 years.' Furthermore, more research demonstrating the outcomes of MRD detection is needed, Grady added. 'A caveat is that studies are still needed showing that if you change your care of patients based on the MRD result, that you improve outcomes,' he said. 'These studies are being planned and initiated at this time, from my understanding.' Oncologists treating patients with CRC are commonly performing MRD assessment with ctDNA assays; however, Grady noted that the practice is still not the standard of care. Regarding the suggestion of ctDNA representing the next major, pivotal step in cancer monitoring, Grady responded that 'I think this is aspirational, and further studies are needed to make this claim.' However, 'it does look like it has the promise to turn out to be true.'
