Natera, Inc.

Signatera™ Genome with Phased and Structural Variants Highlighted in ESMO Presidential Symposium, Supporting the Critical Role of MRD-Guided Treatment in Bladder Cancer

Natera's Signatera Genome assay was featured in the ESMO Presidential Symposium presentation of the phase III VOLGA trial in muscle-invasive bladder cancer, part of 25 ESMO abstracts including 9 oral presentations. VOLGA showed Signatera ctDNA dynamics were highly predictive of event-free survival: 24-month EFS was 91% for persistently ctDNA-negative patients versus 55% for those who stayed positive. Signatera has now been evaluated in seven phase III bladder cancer trials, and additional ESMO data in lung (99% pre-treatment ctDNA detection), endometrial, and breast cancer further broaden the evidence base supporting MRD-guided treatment decisions.

•5d ago

Natera Shares Real-World Analyses and Data at ASN Kidney Week 2026, Highlighting the Critical Need for Genetic Testing with Renasight™

Natera presented 18 abstracts, including three oral presentations, at ASN Kidney Week 2026 supporting its Renasight genetic test for chronic kidney disease. Real-world data showed median time from first abnormal kidney indicator to diagnosis of about 5.3 years, and only 26.6% of high-risk patients with hereditary or structural kidney disease had documented nephrology care. The company is positioning Renasight for earlier etiologic evaluation and standard-of-care status in CKD management; this is evidence-generation marketing rather than a regulatory or financial catalyst.

•6d ago

ESMO 2026 Presentations Deepen the Evidence Base for Natera’s Oncology Portfolio and Leadership in Ultrasensitive MRD Technology

Natera announced 20 abstracts featuring its technology at the 2026 ESMO Annual Congress, October 23-26 in Madrid, including 4 rapid oral presentations. The program features Signatera Genome with Phased and Structural Variants, which achieved an LOD95 below 1 part per million and detection significantly below 1 part per 10 million. Highlighted data include the ICONIC trial in gastroesophageal cancer showing a >7.3-month median lead time over imaging, and the phase III SAGITTARIUS trial in colon cancer where Signatera results changed pre-planned treatment for one in three patients, 87% of whom were de-escalated on MRD negativity. The breadth of evidence across tumor types strengthens the clinical-utility case for Natera's MRD franchise but carries no near-term financial impact.

•14d ago

Natera’s Signatera™ MRD Test Named to TIME’s List of the Best Inventions of 2026

Natera's Signatera MRD test was named to TIME's Best Inventions of 2026 list in the Medical & Healthcare category. Natera was also named to Fortune's Future 120 list in October 2026, highlighting companies poised to define the next chapter of business and innovation. Signatera remains the most widely adopted and extensively validated MRD test, supported by more than 200 peer-reviewed publications and used by more than 55% of U.S. oncologists.

•17d ago

Natera and TransCode Therapeutics to Collaborate on Phase 2a Trial of TTX-MC138 in Colorectal Cancer

Natera announced a strategic collaboration with TransCode Therapeutics to use the Signatera MRD test to identify MRD-positive colorectal cancer patients for TransCode's Phase 2a trial of TTX-MC138. The trial, run by Quantum Leap Healthcare Collaborative within the PRE-I-SPY program, marks that platform's first expansion beyond breast cancer into colorectal cancer. For Natera, the deal extends Signatera's biopharma footprint and supports growing momentum behind MRD-guided treatment strategies, though no financial terms were disclosed.

•19d ago

FDA Grants Breakthrough Device Designation for Natera’s Multi-Cancer Early Detection Assay

Natera's multi-cancer early detection (MCED) assay received FDA Breakthrough Device designation, supporting faster development and review for premarket approval or marketing authorization. The designation was based on data across 12 cancer types, with the FDA citing sensitivity, specificity, and cancer signal origin performance. Breakthrough designation speeds regulatory review but does not itself approve the assay; Natera must still complete the premarket pathway before commercialization as an FDA-approved product.

•23d ago

Natera Announces Randomized, Signatera™-Guided Interventional Study in Melanoma

Natera announced first patients enrolled in a randomized, Signatera-guided interventional trial in advanced melanoma (NCT07504796), sponsored by NYU Langone Health. After six weeks of Nivolumab+Relatlimab, Signatera-positive patients without radiographic progression will be randomized to continue first-line therapy or intensify with Ipilimumab, with progression-free survival as the primary endpoint. If positive, the trial could support broader adoption of MRD-guided therapy escalation in melanoma, expanding Signatera's clinical evidence base.

•25d ago

New Signatera™ Data Presented at ASTRO Conference, Highlights Utility for Radiation Oncologists

Natera presented four oral abstracts on Signatera at the ASTRO 2026 Annual Meeting, its first participation in the radiation oncology conference. Data from Memorial Sloan Kettering showed 100% sensitivity and 97% specificity for detecting recurrence in locally advanced rectal cancer, while Signatera positivity after chemoradiation in anal squamous cell carcinoma marked an 18-month progression-free survival of just 8% versus 97% for negative patients. Gynecologic cancer studies showed Signatera positivity preceded radiographic recurrence with a median lead time of 117 days, supporting broader use in radiotherapy monitoring and risk stratification.

•26d ago

Alliance Foundation Trials and Natera Announce AFT-70 NAVIGATE: a Global, Randomized, Phase III Trial Evaluating Genentech’s Oral Selective Estrogen Receptor Degrader (SERD) with Signatera™ MRD-Guided CDK4/6 Inhibitor Therapy in Breast Cancer

Alliance Foundation Trials and Natera launched AFT-70 NAVIGATE, a global randomized Phase III trial testing an MRD-guided treatment strategy in ER-positive/HER2-negative early breast cancer, with Signatera serving as the molecular residual disease test. The trial pairs Genentech's investigational oral SERD giredestrant with longitudinal Signatera Genome monitoring, aiming to spare patients unnecessary CDK4/6 inhibitor exposure; primary endpoint is non-inferiority in 4-year distant recurrence-free survival. More than 2,000 patients will be enrolled at roughly 200 sites across the U.S. and internationally, with co-funding from Natera and Genentech. For Natera, selection over competing MRD assays reinforces Signatera's clinical evidence moat in breast cancer and could expand standard-of-care adoption if positive.

•27d ago

Signatera™ Receives Regulatory Approval in Japan as a Companion Diagnostic in Muscle-Invasive Bladder Cancer

Natera's Signatera test received approval from Japan's PMDA as a companion diagnostic in muscle-invasive bladder cancer, supporting Signatera-guided adjuvant atezolizumab (Tecentriq) treatment decisions. This is the second PMDA authorization for Signatera in three months, following colorectal cancer approval in June 2026, and the first PMDA-approved CDx in MRD-guided care. Approval was supported by the phase III IMvigor011 trial, which included more than 20 sites in Japan. Natera expects a Japanese commercial launch in the first half of 2027, pending final reimbursement and pricing decisions.

•1mo ago

Largest MRD Study in Lung Cancer Highlights Strong Prognostic Value for SignateraTM

Natera presented the largest molecular residual disease dataset ever reported in lung cancer at the IASLC 2026 World Conference on Lung Cancer in Seoul, analyzing 1,129 patients with resected stage 1-3 non-small cell lung cancer from 2016 to 2025. Signatera-positive patients had approximately 5X the risk of recurrence or death during surveillance, while Signatera-negative patients in the early post-surgical window showed a 25% higher absolute three-year recurrence-free survival. Findings were consistent across both primary surgical and perioperative cohorts, supporting broad applicability of Signatera monitoring across resected stage 1-3 NSCLC. The dataset meaningfully strengthens Signatera's evidence base in lung cancer, the most commonly diagnosed cancer globally, and could influence adjuvant treatment decisions and future payer coverage in a key growth indication for Natera's oncology franchise.

•1mo ago

New Publication Establishes Strong Clinical Validation of Signatera™ for MRD Assessment in Lymphoma

Natera announced the publication of a prospective study in Blood Neoplasia validating Signatera for molecular residual disease assessment in lymphoma, showing 100% positive predictive value at end-of-treatment compared to 62% for PET/CT scans. The study of 144 patients found Signatera was the strongest independent predictor of event-free survival (HR 80.83 vs 5.18 for imaging) and demonstrated 91% sensitivity and 92% specificity during surveillance. For patients post CAR-T therapy, Signatera clearance was associated with a median durable treatment interval of 16.1 months versus 1.97 months for those who remained positive.

•2mo ago

Natera and Susan G. Komen® Announce National Partnership to Accelerate Progress Against Breast Cancer

Natera announced a national partnership with Susan G. Komen to accelerate breast cancer awareness and education regarding molecular residual disease testing. The company will serve as the 2026 Premier National Series Sponsor of Komen’s Race for the Cure and MORE THAN PINK Walk events, supporting initiatives to reach patients and clinicians. This collaboration leverages Natera’s Signatera test, which is supported by more than 185 peer-reviewed publications, to advance evidence generation in breast cancer care.

•2mo ago

Natera and Angiex Partner to Assess Response to Investigational Nuclear-Delivered Antibody-Drug Conjugate™ Using Signatera™

Natera partnered with Angiex to deploy its Signatera test in a Phase I trial of AGX101, a novel Nuclear-Delivered Antibody-Drug Conjugate for advanced solid tumors. The collaboration will use longitudinal circulating tumor DNA monitoring to assess treatment response, aiming to complement radiologic assessments for patients with unresectable or metastatic disease. This trial is currently enrolling patients and will explore whether molecular response data can improve the understanding of AGX101's efficacy profile.

•2mo ago

Natera to Support New Clinical Trial Assessing ctDNA Dynamics with Latitude™ in Advanced Skin Cancers

Natera announced a collaboration with Kupando Therapeutics to support a Phase 1 clinical trial evaluating the immunotherapy candidate KUP-101 using Natera’s Latitude MRD test. The trial will assess serial ctDNA dynamics to monitor treatment response in patients with advanced skin cancers, with the first patient already dosed and enrollment ongoing in Germany. Management noted that Latitude is well-suited to evaluate molecular response across solid tumor types, supporting the development of this innate immune activation therapy.

•2mo ago

Natera Reports Second Quarter 2026 Financial Results

Natera reported strong Q2 results with revenue up 38% year-over-year to $752.8 million, driven by a 22% increase in test volumes and 57% growth in oncology tests. Management raised full-year 2026 revenue guidance by $100 million at the midpoint to a range of $2.85 billion to $2.91 billion, while also projecting positive cash flow for the year. Gross margin expanded to 64.5% and GAAP losses narrowed significantly to ($0.47) per share from ($0.74) in the prior-year period.

•2mo ago

Natera Submits Signatera™ to Japan’s PMDA for Approval as a Companion Diagnostic in Muscle-Invasive Bladder Cancer

Natera submitted an application to Japan's Pharmaceuticals and Medical Devices Agency for approval of Signatera as a companion diagnostic in muscle-invasive bladder cancer. The submission is backed by data from the Phase 3 IMvigor011 trial and builds on the recent U.S. FDA approval of Signatera for use with atezolizumab in this indication. Signatera previously secured PMDA approval in Japan for colorectal cancer, marking a continued expansion of Natera's precision diagnostics footprint in the region.

•2mo ago

Signatera™ MRD Outperformed AMERK Testing in Predicting Merkel Cell Carcinoma Recurrence in JAMA Dermatology Study

Natera announced results from a study published in JAMA Dermatology showing its Signatera test outperformed the standard AMERK test in predicting Merkel Cell Carcinoma recurrence. In the 169-patient study, Signatera demonstrated superior sensitivity (90% vs 55%) and detected relapse earlier, with a median lead time of 5.1 months compared to 2.1 months for AMERK. The data supports Signatera as a more reliable biomarker for all MCC patients regardless of viral status, reinforcing its inclusion in NCCN Guidelines for surveillance.

•3mo ago

Finalized MolDx LCD Includes Expanded Coverage for Natera’s Prospera™ Portfolio

The final MolDx LCD (L40060) significantly expands coverage for Natera’s Prospera tests in kidney, heart, and lung transplant surveillance settings. The new policy, effective August 30, 2026, allows up to 12 tests in the first year for heart and lung patients and 6 for kidney patients, improving upon a restrictive draft that proposed only 2-4 tests annually. Major medical societies supported the updated policy, which strengthens Natera's reimbursement position and facilitates earlier detection of organ rejection.

•3mo ago

Natera Announces IVDR Certification for Signatera™ Across Multiple Cancers

Natera announced that its Signatera personalized molecular residual disease (MRD) test has received Class C certification under the EU’s In Vitro Diagnostic Regulation (IVDR). This certification allows Natera to continue offering Signatera to EU patients after the 2028 IVDD transition deadline and reduces regulatory overhead for launching new clinical trials. Signatera is indicated for use across multiple solid tumors and lymphomas, including gastrointestinal, genitourinary, lung, breast, and skin cancers, as well as immunotherapy monitoring.

•3mo ago

Signatera™ MRD Test Predicted Overall Survival Benefit from Chemotherapy in Resected Metastatic Colorectal Cancer

Natera announced the publication of data in JAMA Oncology demonstrating that its Signatera test predicts overall survival benefit from adjuvant chemotherapy in patients with resected metastatic colorectal cancer. The study of 298 patients found that MRD-positive patients who received chemotherapy had significantly improved overall survival compared to observation, while MRD-negative patients derived no significant benefit. This is the first large dataset to show MRD prediction of overall survival in this population, reinforcing the test's utility in personalizing treatment decisions.

•3mo ago

Natera and Aveta Biomics Announce Strategic Partnership Supporting Global Phase 3 Registrational Trial of APG-157 in Head and Neck Cancer

Natera and Aveta Biomics announced a strategic partnership to support Aveta’s global Phase 3 registrational trial of APG-157 in head and neck cancer. Signatera will be used to evaluate molecular response and detect molecular residual disease (MRD) across approximately 826 patients enrolled in the study. The trial is expected to begin enrollment in the second half of 2026, adding to Natera’s growing evidence base for Signatera in this histology.

•4mo ago

Natera and Eledon Announce Strategic Partnership for Prospera™ Monitoring in Planned Phase 3 Kidney Transplant Trial

Eledon Pharmaceuticals partnered with Natera to exclusively use the Prospera dd-cfDNA test in its planned Phase 3 trial of tegoprubart for kidney transplantation. The trial is expected to enroll approximately 600 patients across over 100 transplant centers globally, with initiation slated for late 2026. Tegoprubart is an investigational anti-CD40L antibody designed to prevent organ rejection while reducing the toxicities associated with current standard-of-care treatments.

•4mo ago

Signatera™ Receives Regulatory Approval in Japan for Colorectal Cancer

Natera announced that its Signatera test received regulatory approval from Japan’s PMDA for colorectal cancer in the adjuvant setting, marking the first MRD test approved in the country. Commercial launch is anticipated by the end of 2026, pending final pricing and reimbursement decisions, backed by position statements from major Japanese oncology societies. The approval was supported by the GALAXY clinical trial, which analyzed over 2,200 samples across more than 150 institutions, demonstrating Signatera's ability to inform adjuvant chemotherapy decisions.

•4mo ago

NCCN Recommends ctDNA-MRD Testing Using Signatera™ Technology in Landmark Bladder Cancer Guideline Update

The National Comprehensive Cancer Network (NCCN) updated its Bladder Cancer guidelines to include Natera's Signatera with a Category 1 recommendation for adjuvant treatment in muscle-invasive bladder cancer. This marks the third NCCN guideline inclusion for Signatera, supported by Phase 3 evidence from the IMvigor011 trial, and validates the test as a prognostic and predictive biomarker. The update follows the May 2026 FDA approval of Signatera CDx, reinforcing its role in guiding post-surgical treatment decisions and risk stratification.

•4mo ago

Natera to Showcase Organ Health Leadership with 21 Presentations at the American Transplant Congress

Natera announced it will present 21 studies, including seven oral presentations, at the upcoming American Transplant Congress highlighting the clinical utility of its Prospera test for transplant monitoring. New data from the PEDAL study of 346 patients indicates that elevated Prospera dd-cfDNA levels in biopsy-negative cases were strongly predictive of adverse outcomes, showing >6X higher rates of graft loss. Additionally, an analysis of 989 patients from the ProActive study demonstrated that persistently low dd-cfDNA levels (<0.5%) were associated with significantly reduced odds of future rejection and graft loss.

•4mo ago

Natera and CytoDyn Announce Strategic Collaboration to Advance ctDNA-Guided Development and Molecular Response Analysis in Metastatic Colorectal Cancer

CytoDyn and Natera announced a strategic collaboration to evaluate circulating tumor DNA (ctDNA) dynamics in CytoDyn’s CLOVER Phase 2 study for metastatic colorectal cancer. Natera will use its Signatera assay to analyze clinical trial samples and provide real-world data insights from its proprietary oncology database, which contains over 2 million plasma timepoints. The partnership aims to generate molecular response insights that may inform future clinical trial design, biomarker-driven patient selection, and broader development strategies for leronlimab.

•4mo ago

Natera Appoints Oncology Leaders Drs. Thomas Lynch and Eric Rubin to Board of Directors

Natera appointed Dr. Thomas Lynch and Dr. Eric Rubin to its Board of Directors, adding deep oncology expertise to its governance structure. Dr. Lynch, President of Fred Hutch Cancer Center, brings decades of experience in solid tumor research and precision medicine, having previously served as CSO at Bristol-Myers Squibb and in leadership roles at Yale and Massachusetts General. Dr. Rubin, former Senior Vice President of Global Clinical Oncology at Merck, led the development of KEYTRUDA and brings extensive experience in large-scale oncology clinical programs. The appointments underscore Natera’s commitment to advancing molecular diagnostics and precision oncology, with both doctors joining specific board committees to support the company’s next phase of innovation.

•4mo ago

Natera Announces Collaboration with Diakonos Oncology for Signatera™ in Refractory Melanoma

Natera announced a collaboration with Diakonos Oncology to use its Signatera test in a Phase I/II trial for refractory melanoma. Signatera will longitudinally assess molecular response via ctDNA analysis for patients receiving DOC1021, a personalized dendritic cell therapy with FDA Fast Track designation. The partnership highlights Signatera’s role as a trusted MRD platform for evaluating treatment dynamics in early-stage immunotherapy trials where imaging may lag biological response.

•5mo ago

Natera Enrolls First Patients in SIGNAL-ER 101, a Prospective, Interventional Study Evaluating MRD-Guided Therapy in Breast Cancer

Natera has enrolled the first patients in SIGNAL-ER 101, a prospective, interventional study evaluating MRD-guided therapy de-escalation in early-stage breast cancer. The study aims to determine if MRD-negative patients can safely defer adjuvant CDK4/6 inhibitor therapy, potentially avoiding serious adverse events and high costs associated with overtreatment. SIGNAL-ER 101 plans to enroll approximately 725 patients across 50 U.S. sites, marking the first in a series of Natera-sponsored trials designed to establish the clinical utility of MRD-guided treatment strategies.

•5mo ago

Natera to Launch Enhanced Panorama™ NIPT, Powered by Novel SNP-Informed Deep Sequencing Technology

Natera launched an enhanced version of its Panorama NIPT test, powered by novel SNP-informed deep sequencing technology. The update is backed by a prospective clinical validation study of 3,323 patients, demonstrating 100% sensitivity for trisomy 21 and 13, and 93.3% for trisomy 18 in low fetal fraction samples. The enhancement reduces the no-call rate to 0.5%, addressing a historical competitive gap and enabling results for more patients on the first draw.

•5mo ago

Natera to Present 35 Studies at ASCO, Extending Clinical Data Leadership in Oncology

Natera will present 35 studies at the 2026 ASCO Annual Meeting, including 3 oral presentations, highlighting its leadership in molecular residual disease (MRD) testing. A large real-world meta-analysis of Signatera across 3,000+ patients and 15 tumor types showed Signatera-positivity was strongly associated with recurrence risk, with hazard ratios of 8.15 in the adjuvant setting and 18.30 in surveillance. The company also unveiled its new 'Annotation' digital platform, which integrates clinical, treatment, and genomic data to provide richer context for Signatera results.

•5mo ago

Natera Announces Expansion in Austin, Creating What Is Believed to Be the Largest Sequencing Facility in the World

Natera is expanding its North Austin headquarters with a new dedicated sequencing facility, which it believes will be the largest in the world. The expansion includes additional lab space in a second building and is expected to create up to 400 new jobs across professional, laboratory, and operational roles. This infrastructure investment supports rapid demand growth, particularly in oncology where year-over-year volumes increased by more than 54% in Q1 2026, and follows the recent FDA approval of Signatera CDx.

•5mo ago

Signatera™ CDx Approved by the FDA as a Companion Diagnostic in Muscle-Invasive Bladder Cancer (MIBC)

The FDA approved Natera's Signatera CDx as a companion diagnostic for use with adjuvant atezolizumab in muscle-invasive bladder cancer (MIBC). This marks the first FDA-approved use of personalized molecular residual disease (MRD) testing to guide treatment decisions in this setting, validating Natera's Treatment on MRD (TOMR) approach. The approval follows the landmark Phase III IMvigor011 trial, which showed MRD-positive patients benefited from immunotherapy while MRD-negative patients achieved 97% two-year overall survival without adjuvant therapy.

•5mo ago

Prospera™ Evidence in Heart and Lung Transplantation Featured Across 17 Presentations at ISHLT

Natera presented 17 abstracts at the ISHLT Annual Meeting, including six oral presentations, to highlight the expanding clinical utility of the Prospera test in heart and lung transplantation. Data from the ProTECT and DEFINE-HT studies demonstrated that Prospera predicted adverse outcomes up to 4x more often than biopsy and influenced physician decisions in over 30% of cases. Additional lung transplant evidence showed Prospera's ability to detect infection and graft injury, with one study showing a 77% quantitative decrease in biomarkers following antireflux surgery.

•6mo ago