AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced the submission of its premarket approval (PMA) to the U.S. Food and Drug Administration (FDA) for Signateraâ"¢ CDx for detection of molecular residual disease (MRD) in patients with muscle-invasive bladder cancer (MIBC) who may benefit from treatment with atezolizumab (Tecentriq®). This submission is supported by data from the randomized, double-blind, phase 3 IMvi. ...

AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced the publication of a new prospective clinical trial in Transplantation Direct. The study, which was conducted by The Ohio State University Wexner Medical Center (OSU-WMC), was initiated to explore whether donor-derived cell-free DNA (dd-cfDNA) surveillance, and specifically Prospera-guided monitoring, could reduce the number of invasive biopsies for patients foll. ...

Core Insights - Natera, Inc. announced new data from the ALTAIR trial will be presented at the 2026 ASCO GI Symposium, highlighting advancements in precision medicine and cell-free DNA technology [1] Group 1: ALTAIR Trial Findings - The ALTAIR trial, a randomized, double-blind, phase III study, demonstrated a statistically significant disease-free survival (DFS) benefit for Trifluridine/Tipiracil (FTD/TPI) compared to placebo in Signatera-positive patients with stage I-IV colorectal cancer, with median DFS of 9.23 months versus 5.55 months (HR: 0.75, 95% CI: 0.55-0.98; P=0.0406) [2] - This analysis represents a significant update from previous ALTAIR findings, which did not show a statistically significant DFS improvement in the full study population [2] Group 2: Prognostic Studies - Natera will present a large-scale study on Signatera velocity as a prognostic marker for relapse risk, indicating that CRC patients with Signatera levels doubling in one month or less had approximately 40% shorter recurrence-free survival compared to those with slower doubling times [3] - The prognostic association of circulating tumor DNA (ctDNA) increase and recurrence risk was significant for both patients who received adjuvant chemotherapy and those who did not [3] Group 3: Company Positioning and Future Directions - Natera's extensive evidence across various tumor types positions the company to define ctDNA dynamics, translating them into actionable clinical insights for cancer management [4] - The company aims to integrate personalized genetic testing and diagnostics into standard care, supported by over 325 peer-reviewed publications demonstrating excellent performance [10]

Summary of the Conference Call Company Overview - The conference is hosted by Piper Sandler, focusing on the healthcare sector, with a specific emphasis on Natera, a diagnostics company specializing in genetic testing and oncology solutions [1][2]. Key Highlights from Natera's Performance - Natera reported a record revenue performance in Q3, surpassing $500 million for the first time in the company's history [3][4]. - The company achieved a gross margin of 64.9%, with an adjusted gross margin of 61.3%, both of which are records for Natera [3][4]. - Clinical signature units exceeded 20,000 in the quarter, contributing to a total of 200,000 clinical units overall [3][4]. Growth Projections - Natera anticipates that its Minimal Residual Disease (MRD) business will exceed $1 billion in revenue within the next two to three years, with current growth rates in the double digits [2][4]. - The company is focusing on absolute growth units rather than growth rates, aiming to maintain stable average selling prices (ASPs) for Women's Health and Organ Health segments [5][6]. Business Segments Performance - Women's Health has shown significant ASP improvements, with current prices for Non-Invasive Prenatal Testing (NIPT) being higher than they were a decade ago [6][7]. - Organ Health is experiencing strong growth, particularly in cell-free DNA testing, which is expected to replace traditional tissue biopsies over time [9][10]. - The oncology segment is still in early stages of market penetration, with expectations of continued growth in MRD volume due to high unmet needs [10][11]. Reimbursement and Coverage - Natera has established itself as a large in-network lab for major payers, facilitating coverage for Medicare Advantage patients [18][19]. - The company is actively working on expanding coverage for various tumor types, with seven submissions ready for the MolDX program to enhance reimbursement opportunities [21][23]. Clinical Trials and Research - The IMvigor trial demonstrated a 41% improvement in overall survival for muscle-invasive bladder cancer patients treated with atezolizumab, highlighting the efficacy of Natera's Signatera test [24][26]. - The company is preparing for the FIND study in 2027, which aims to evaluate the performance of its tests in advanced adenomas [34][35]. Market Dynamics and Competitive Landscape - Natera is leveraging its strong data and clinical utility to negotiate pricing and contracts with payers, ensuring a collaborative relationship that emphasizes the savings generated for the healthcare system [20][22]. - The company is exploring additional clinical questions and opportunities alongside its Signatera test, particularly in the context of tissue genomics [30][32]. Conclusion - Natera is positioned for strong growth across its business segments, with a focus on expanding its market presence, enhancing reimbursement strategies, and continuing to deliver innovative diagnostic solutions [12][12].