Natera, Inc. develops and commercializes cell-free DNA and genetic testing for oncology, women’s health and organ health. Company updates commonly cover financial results, revenue trends, laboratory operations and publications supporting tests such as Signatera, Prospera, Panorama and Horizon.
Recurring news also includes oncology molecular residual disease applications, clinical evidence presented at medical meetings, transplant rejection surveillance data, collaborations using Natera assays in drug trials, and patent or litigation developments tied to its MRD technology. The company reports through CLIA-certified and CAP-accredited laboratory operations and through Foresight Diagnostics, its subsidiary.
Natera (NASDAQ: NTRA) has published a groundbreaking study in the Journal of Clinical Oncology - Precision Oncology validating its Signatera™ test for testicular cancer. The multi-institutional study, analyzing 324 plasma samples from 74 patients, demonstrated that Signatera significantly outperformed standard serum tumor markers (STM) in predicting patient outcomes.
The study revealed impressive detection rates with Signatera showing 91.6% positivity for stage I and 100% for stages II and III. Notably, Signatera-positive patients showed significantly shorter event-free survival compared to Signatera-negative patients, with a hazard ratio of 12.45 (p0.0001) during surveillance, while conventional STMs failed to show significant correlation with outcomes.
Natera (NASDAQ: NTRA) has published a new study in the Journal of Clinical Oncology Precision Oncology validating its Signatera™ test for monitoring uterine cancer recurrence. The multi-center study analyzed 233 plasma samples from 61 patients with stage I/II uterine cancer.
The study demonstrated that Signatera achieved 100% detection of cancer recurrences before clinical confirmation, with a median lead time of 3.1 months. The test proved highly prognostic in both postoperative (HR=7.6) and post-definitive therapy (HR=25.4) settings, outperforming traditional risk assessment methods. Notably, no patients who tested consistently negative with Signatera experienced recurrence.
Natera (NASDAQ: NTRA) provided an update on its patent litigation with NeoGenomics. The U.S. District Court for the Middle District of North Carolina invalidated certain claims in two patents related to NeoGenomics' v1.1 RaDaR test. However, this ruling does not affect U.S. Patent No. 11,519,035, which previously secured both preliminary and permanent injunctions against NeoGenomics' RaDaR v1.0 product.
The company is considering its options, including an appeal and enforcement of other patents. Natera emphasizes its strong intellectual property position with over 500 issued or pending patents worldwide and remains committed to protecting its innovation investments.
Natera (NASDAQ: NTRA) has announced the activation of the ARCHER (NRG-GU015) trial, a pivotal Phase III study in muscle-invasive bladder cancer (MIBC). The study will evaluate whether a shorter radiation course can match current standard-of-care outcomes, incorporating Natera's Signatera™ personalized molecular residual disease (MRD) test as a secondary endpoint.
The trial, sponsored by NRG Oncology through the National Cancer Institute, will involve over 100 sites across the U.S. and Canada. Signatera will monitor circulating tumor DNA (ctDNA) clearance patterns to predict treatment response and recurrence, with additional exploration of urine tumor DNA. The test has been clinically validated to detect MIBC recurrence earlier than standard imaging.
This initiative builds on Natera's existing MIBC clinical evidence, including positive results from the IMVigor011 trial, which demonstrated Signatera's effectiveness in predicting immunotherapy benefits post-cystectomy.
Natera (NASDAQ: NTRA) announced upcoming presentations at the 2025 International Association for the Study of Lung Cancer (IASLC) World Conference in Barcelona, Spain from September 6-9. The company will showcase new data demonstrating the clinical utility of its Signatera™ technology in lung cancer patients.
A key highlight includes an oral presentation featuring analysis of Signatera Genome in early-stage, resectable non-small cell lung cancer (NSCLC) patients, showing its prognostic value for recurrence-free and overall survival in post-surgical molecular residual disease assessment. Three presentations will cover various aspects of Signatera's application in lung cancer monitoring and treatment outcomes.
Natera (NASDAQ: NTRA), a leader in cell-free DNA testing and precision medicine, has achieved a significant milestone with over 300 peer-reviewed publications featuring its technology. The publications span prestigious journals including Nature, Nature Medicine, and others, demonstrating the company's scientific leadership.
The milestone encompasses 150+ oncology publications (140+ focused on Signatera™), 100+ publications on Women's Health technologies, and 60+ publications on Organ Health solutions. These studies validate Natera's contributions to disease detection and clinical decision-making across multiple medical disciplines.
Natera (NASDAQ: NTRA) has launched its proprietary AI foundation model platform aimed at advancing diagnostic and therapeutic innovation in precision medicine. The platform is built on one of the largest multimodal oncology datasets, including over 250,000 tumor exomes and 1 million+ plasma timepoints.
The platform consists of three integrated layers: a data foundation layer with extensive oncology datasets, a core model layer powered by over 1 billion parameters, and an application layer featuring tools like the Digital Patient Simulator, Real-Time Trial Matching, and NeoPredict. Initial pilot programs have demonstrated strong performance in recommending immunotherapy and predicting treatment responses.
Natera (NASDAQ: NTRA) has announced positive topline results from the Phase III IMvigor011 trial in muscle-invasive bladder cancer (MIBC), utilizing their Signatera ctDNA test. The trial demonstrated that Signatera-positive patients treated with atezolizumab showed significant improvements in disease-free survival and overall survival.
The study enrolled approximately 760 patients who underwent Signatera testing post-surgery. Notably, patients who remained Signatera-negative showed exceptional outcomes, with 100% overall survival at 12 months and 98% at 18 months. Disease-free survival rates were 92% at 12 months and 88% at 18 months after surgery.
Following these results, Natera will finalize its premarket approval application to the FDA for Signatera as a companion diagnostic for atezolizumab treatment selection in MIBC patients post-cystectomy.
Natera (NASDAQ: NTRA) reported strong Q2 2025 financial results with total revenues of $546.6 million, up 32.2% year-over-year. The company achieved significant milestones including a gross margin of 63.4% and processed 853,100 tests, a 12.2% increase from Q2 2024.
Notable highlights include 50.6% growth in oncology tests to 188,800 units and positive cash flow of $24.3 million. The company raised its 2025 revenue guidance to $2.02-$2.10 billion, an $80 million increase at the midpoint. However, Natera reported a net loss of $100.9 million ($0.74 per share), impacted by legal accruals and stock-based compensation expenses.
Natera (NASDAQ: NTRA) has launched Fetal Focus, a groundbreaking noninvasive prenatal test (NIPT) for inherited conditions. The test addresses a critical gap in prenatal care by screening fetuses directly for five commonly tested genes when the biological father is unavailable for testing.
The launch is backed by initial data from the EXPAND clinical trial, which has enrolled approximately 1,300 participants. In its first milestone readout (n=101), Fetal Focus demonstrated 91% sensitivity and successfully identified all 5 cases of homozygous variants. The test utilizes Natera's proprietary LinkedSNP™ technology and is validated for analyzing genes associated with cystic fibrosis, spinal muscular atrophy, alpha-thalassemia, and beta-hemoglobinopathies including sickle cell disease.