Natera, Inc. - NTRA STOCK NEWS

Natera has announced the enrollment of the first patients in the SAGITTARIUS clinical trial, a phase III study aimed at using Signatera to guide personalized adjuvant treatment strategies for colon cancer. Sponsored by the AIRC Institute of Molecular Oncology and funded by the European Union Horizon Europe Programme, the study plans to enroll 700-900 patients across more than 20 sites. The trial will compare genotype-guided therapy versus standard chemotherapy for Signatera-positive patients and explore the use of immunotherapy and targeted agents earlier in the disease course. For Signatera-negative patients, the trial will assess treatments chosen by physicians, with options for observation or single-agent capecitabine. SAGITTARIUS involves collaborations with 9 partners in 5 European countries and a network of 26 clinical centers in Italy, Spain, and Germany. The trial aims to personalize treatment approaches and potentially reduce chemotherapy for certain patients.

Natera (NASDAQ: NTRA) and MyOme have launched an integrated polygenic risk score (iPRS) for personalized breast cancer risk assessment. This new tool is offered with Natera's Empower hereditary cancer test and reports 5-year and lifetime breast cancer risk. iPRS provides further risk assessment for individuals who test negative for hereditary cancer mutations, enhancing predictions beyond the traditional Tyrer-Cuzick (T-C) model. A validation study of over 130,000 women, published in JCO Precision Oncology, showed that MyOme's cross-ancestry iPRS significantly improved breast cancer risk prediction, reclassifying up to 8% of women's T-C lifetime risk. This score integrates over 1 million single nucleotide polymorphisms (SNPs) from whole genome sequencing with T-C clinical inputs, offering a comprehensive risk assessment based on genetic ancestry. iPRS aims to identify higher-risk individuals, enabling proactive screening and early treatment, important for improving breast cancer outcomes. iPRS is available to women aged 18-85 with no personal history of breast cancer and no mutations in breast cancer-related genes.

Natera (NASDAQ: NTRA) announced the publication of its clinical validation study on the Fetal RhD noninvasive prenatal test (NIPT) in Obstetrics & Gynecology. This study, the largest of its kind in the U.S., demonstrated high performance metrics with 100% sensitivity and 99.3% specificity. The study involved 655 RhD-negative pregnant patients, confirming fetal RhD status via newborn serology. Key results included 356/356 fetuses correctly identified as RhD positive and 295/297 as RhD negative. The test also showed a positive predictive value of 99.4% and a negative predictive value of >99.9%. The study emphasized the test's potential to assist in the prevention and management of RhD alloimmunization, especially amid RhIg shortages. The NGS-based test can identify RHD pseudogene and hybrid variants common in non-European ancestries. Experts highlight the test's potential to transform care for RhD-negative pregnant patients, aligning with ACOG's guidance on cfDNA screening for fetal RhD testing.

Natera announced that its Prospera Lung test has received Medicare coverage from CMS's MolDX Program for single lung transplant (SLT) recipients in surveillance settings. SLT patients represent ~20% of U.S. lung transplants and face higher risks of rejection and biopsy complications. The test's performance was validated in the SLAM study, showing an AUC-ROC of 0.85 in distinguishing rejection, infection, and CLAD from stable patients, with 77.8% sensitivity, 84.6% specificity, and 96.8% NPV. Prospera Lung is now used by over half of U.S. lung transplant centers.

Natera (NASDAQ: NTRA) announced its upcoming presentation of new SignateraTM data at the San Antonio Breast Cancer Symposium (SABCS), December 10-13. The company will present six abstracts, including significant findings from the ZEST clinical trial, which showed improved disease-free survival with niraparib treatment in ctDNA-positive breast cancer patients (11.4 months vs 5.4 months for placebo).

Key highlights include a clinical genomics study revealing 44% of Signatera-positive patients had targetable genomic alterations, with 34.5% showing PIK3CA mutations. Additionally, four abstracts will present patient-reported outcomes indicating that ctDNA testing provides valuable treatment planning information without increasing patient anxiety.

A federal court jury unanimously ruled in favor of Guardant Health in its lawsuit against Natera for false advertising and unfair competition. The jury awarded $292.5 million to Guardant Health, including $175.5 million in punitive damages, making it one of the largest false advertising verdicts in history. The case, filed in May 2021, centered on Natera's deliberate campaign to mislead cancer clinicians about Guardant Reveal™, a tissue-free minimal residual disease test for early-stage colorectal cancer. The jury rejected all of Natera's counterclaims.

Natera has responded to a jury decision favoring Guardant Health in a false advertising case from 2021. The litigation involved mutual claims regarding statements about Guardant's Reveal test. Natera disagrees with the verdict and plans to appeal. The company emphasizes that the case focused solely on comparative advertisements from 2021 and does not affect their Signatera test, which has become the leading MRD test in the U.S., supported by over 100 peer-reviewed publications.

Natera co-founder and executive chairman Matthew Rabinowitz has been named 2024 R&D Leader of the Year by R&D World. The organization recognized his pioneering work in genetic testing and precision medicine, particularly highlighting the development of transformational products including: Panorama™ for prenatal screening, Signatera™ for cancer recurrence detection, and Prospera™ for transplant rejection risk assessment. Dr. Rabinowitz, who served as CEO from 2005 to 2019, has authored numerous publications in prestigious journals and holds multiple patents in the field.

Natera has achieved a significant milestone with over 100 peer-reviewed publications on Signatera, its personalized molecular residual disease (MRD) test. The studies, published in prestigious journals like Nature and Journal of Clinical Oncology, demonstrate excellent clinical performance and utility. Signatera, the most widely used MRD test in the U.S., has served more than 200,000 cancer patients. The company continues to expand its research pipeline with several phase III randomized clinical trials across various cancer types.