COMPANY:

Natera

" Natera...today announced it will expand its Fetal Focus test to cover 20 genes, marking a major advancement in single-gene noninvasive prenatal testing (sgNIPT). Building on the success of the initial Fetal Focus 5-gene test, launched in August, the new expanded panel will launch in Q4 2025."

"Natera...today announced another successful readout for its ECD program, which is evaluating a blood-based screening test for the detection of CRC and advanced adenomas (AA). This latest analysis from the U.S. based, prospective PROCEED-CRC clinical trial (NCT06620627) focused on the detection of AAs, which are precancerous polyps with specific features that indicate a higher risk of progression to colorectal cancer. Detecting these lesions early is a critical step in preventing cancer before it develops."

"Natera, Inc...today announced results from the randomized, double-blind, phase 3 IMvigor011 clinical trial in muscle-invasive bladder cancer (MIBC). The findings demonstrate that Signatera can expand the adjuvant treatment window and guide the use of adjuvant atezolizumab (Tecentriq®) in MIBC, resulting in improved disease-free survival (DFS) and overall survival (OS). Results will be presented today during a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress."

"Natera, Inc...today announced the publication of a new study in the Journal of Clinical Oncology Precision Oncology (JCO PO), validating Signatera for recurrence monitoring and treatment response assessment in patients with early-stage uterine cancer."

''Natera, Inc...today announced the publication of a peer-reviewed manuscript in the Journal of Clinical Oncology – Precision Oncology (JCO PO). The paper features results from a multi-institutional study evaluating circulating tumor DNA (ctDNA) as a prognostic biomarker for patients with germ cell tumors (GCT), including testicular cancer.''

"Natera, Inc...today provided an update regarding its intellectual property litigation with NeoGenomics, Inc...The U.S. District Court for the Middle District of North Carolina issued a ruling invalidating certain claims in two patents that Natera asserted against NeoGenomics’ v1.1 RaDaR test. Natera is evaluating its options, including an appeal and further enforcement with other patents."

"Natera, Inc...today announced that it will present new data at the 2025 International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer, taking place September 6 – 9 in Barcelona, Spain. The presentations underscore the strong clinical utility of Signatera in lung cancer."

"Natera, Inc...today announced the activation of the NRG Oncology trial, ARCHER (NRG-GU015), a randomized, phase III study in muscle-invasive bladder cancer (MIBC). The study is evaluating whether a shorter course of radiation can achieve outcomes comparable to the current standard of care. It prospectively incorporates Signatera, Natera’s personalized, tumor-informed molecular residual disease (MRD) test, as a pre-specified secondary endpoint"

"Natera, Inc...today announced the launch of its proprietary AI foundation model platform. These models and applications, which were developed in-house, are designed to drive innovation across therapeutic development, from early target discovery to real-time clinical decision support. The platform features a modular, multimodal architecture composed of three integrated layers."

"IMvigor011 utilizes the Signatera ctDNA test in patients with MIBC to detect molecular residual disease (MRD) in the bloodstream after surgery and predict who will benefit from adjuvant treatment with the cancer immunotherapy atezolizumab (Tecentriq)...Approximately 760 patients were enrolled in the surveillance phase of the trial and underwent serial Signatera testing for up to 12 months post surgery.Topline results from IMvigor011 demonstrated a statistically significant and clinically meaningful improvement in disease-free survival and overall survival for Signatera-positive patients treated with atezolizumab. Natera expects trial data to be presented at an upcoming medical conference."

"Natera, Inc...today announced the launch of the TEODOR trial (Neoadjuvant TrEatment Optimization driven by ctDNA and endOcrine Responsiveness). TEODOR is a Phase II, multicenter, randomized controlled trial (RCT) that aims to replace chemotherapy with endocrine therapy prior to surgery for a subset of women with hormone receptor-positive (HR+), HER2-negative breast cancer, who are endocrine responsive and test negative with Signatera."

"Natera, Inc...today announced that it will present several new datasets at the 2025 World Transplant Congress (WTC), taking place August 2 – 6 in San Francisco, CA."