Latest news with #Signatera-positive
Yahoo
a day ago
- Business
- Yahoo
SignateraTM Genome Clinical Performance Highlighted at ASCO 2025
Overall pan-cancer sensitivity of 94% and specificity of 100%, with analytical detection down to 1 PPM AUSTIN, Texas, June 02, 2025--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, announced results from a large-scale pan-cancer study of its Signatera Genome assay, which was presented today, June 2nd, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The study analyzed the performance of Signatera Genome in a cohort of 392 patients (> 2,600 plasma samples) across five different tumor types (breast cancer, non-small cell lung cancer, melanoma, renal cell carcinoma, and colorectal cancer). Key results included: Excellent pan-cancer performance: Signatera Genome demonstrated overall longitudinal sensitivity of 94% and specificity of 100% across 5 cancer types. Longitudinal sensitivity was 100% in lung cancer and renal cancer, and post-surgical landmark sensitivity was over 70% in both lung cancer and breast cancer. Ultrasensitive detection: In the surveillance setting, nearly 50% of Signatera-positive cases were detected in the ultra-sensitive range (≤100 parts per million). Highly predictive of long-term outcomes: In the pancancer cohort, patients who tested Signatera-negative had excellent prognosis, with 100% distant relapse-free survival (DRFS) at 12 months and 99% at 24 months. In contrast, Signatera-positive patients faced a markedly higher risk of recurrence, with DRFS dropping to 41% at 12 months and just 14% at 24 months. Extended lead times: Signatera Genome detected recurrence 3 months earlier, on average, compared to the Signatera Exome assay. Demonstrates Signatera's potential to identify which patients may benefit from adjuvant therapy: Among Signatera-positive patients, those who received adjuvant therapy had significantly improved outcomes, with a 12-month DRFS of 83% compared to 49% for those who did not receive therapy. For Signatera-negative patients, there was no meaningful benefit from adjuvant therapy with a 12-month DRFS of 93% (treated) vs. 98% (observation). "These results highlight that our ultra-sensitive Signatera Genome assay not only enables detection of ctDNA at extremely low levels, but also provides powerful insights into patient prognosis and treatment response," said Alexey Aleshin, M.D., MBA, corporate chief medical officer and general manager of oncology at Natera. "This is one of the largest MRD studies of a genome tumor-informed MRD assay, and reinforces the excellent performance of Signatera across a wide range of solid tumors." 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
a day ago
- Business
- Business Wire
Signatera TM Genome Clinical Performance Highlighted at ASCO 2025
AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, announced results from a large-scale pan-cancer study of its Signatera Genome assay, which was presented today, June 2nd, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The study analyzed the performance of Signatera Genome in a cohort of 392 patients (> 2,600 plasma samples) across five different tumor types (breast cancer, non-small cell lung cancer, melanoma, renal cell carcinoma, and colorectal cancer). Key results included: Excellent pan-cancer performance: Signatera Genome demonstrated overall longitudinal sensitivity of 94% and specificity of 100% across 5 cancer types. Longitudinal sensitivity was 100% in lung cancer and renal cancer, and post-surgical landmark sensitivity was over 70% in both lung cancer and breast cancer. Ultrasensitive detection: In the surveillance setting, nearly 50% of Signatera-positive cases were detected in the ultra-sensitive range (≤100 parts per million). Highly predictive of long-term outcomes: In the pancancer cohort, patients who tested Signatera-negative had excellent prognosis, with 100% distant relapse-free survival (DRFS) at 12 months and 99% at 24 months. In contrast, Signatera-positive patients faced a markedly higher risk of recurrence, with DRFS dropping to 41% at 12 months and just 14% at 24 months. Extended lead times: Signatera Genome detected recurrence 3 months earlier, on average, compared to the Signatera Exome assay. Demonstrates Signatera's potential to identify which patients may benefit from adjuvant therapy: Among Signatera-positive patients, those who received adjuvant therapy had significantly improved outcomes, with a 12-month DRFS of 83% compared to 49% for those who did not receive therapy. For Signatera-negative patients, there was no meaningful benefit from adjuvant therapy with a 12-month DRFS of 93% (treated) vs. 98% (observation). 'These results highlight that our ultra-sensitive Signatera Genome assay not only enables detection of ctDNA at extremely low levels, but also provides powerful insights into patient prognosis and treatment response,' said Alexey Aleshin, M.D., MBA, corporate chief medical officer and general manager of oncology at Natera. 'This is one of the largest MRD studies of a genome tumor-informed MRD assay, and reinforces the excellent performance of Signatera across a wide range of solid tumors.' 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
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
28-01-2025
- Business
- Yahoo
Natera reports new data from Phase III study of colorectal cancer detection test
Natera has reported the latest data from the Phase III CALGB (Alliance)/SWOG 80702 study, indicating that Signatera, a molecular residual disease test could be instrumental in improving treatment outcomes for colorectal cancer patients. This study assessed whether subjects with detectable molecular residual disease post-surgery could benefit from an escalated adjuvant treatment regimen. The trial utilised Signatera to determine the benefits of adding celecoxib to the standard of care adjuvant chemotherapy with FOLFOX for stage III colorectal cancer management. Nearly 1,000 subjects with post-surgical plasma samples were involved in pre-specified analysis and received FOLFOX with or without celecoxib. The study's key findings demonstrated that subjects who were Signatera-positive after surgery had a significant disease-free survival (DFS) and overall survival (OS) benefit when celecoxib was added to their adjuvant FOLFOX therapy. Specifically, the addition of celecoxib significantly improved DFS in comparison to placebo, with a three-year DFS of 44.1% versus 26.6%. The OS results mirrored this benefit. Conversely, no survival advantage was observed for Signatera-negative subjects when celecoxib was added to their chemotherapy regimen. Moreover, the test status post-surgery was highly predictive of cancer recurrence, with positivity being significantly associated with worse DFS and OS outcomes. Natera oncology general manager and corporate chief medical officer Alexey Aleshin said: 'The results from the CALGB (Alliance)/SWOG 80702 study mark an unprecedented moment in personalised medicine for patients with colorectal cancer. 'We demonstrated Signatera's ability to predict a benefit in both disease-free survival and overall survival for Signatera-positive patients from the addition of celecoxib, an extremely accessible, affordable and well-tolerated therapy.' Signatera leverages circulating tumour DNA for identifying and quantifying residual cancer, enabling earlier recurrence detection. The test is used for several malignancies including breast, muscle-invasive bladder, ovarian and colorectal cancer. It has been clinically validated across various cancer types. Last month, the company commenced enrolment in the Phase III SAGITTARIUS trial, aiming to evaluate the Signatera test in personalising adjuvant treatment strategies for stage III and high-risk stage II colon cancer subjects after surgical resection. "Natera reports new data from Phase III study of colorectal cancer detection test" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
