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Natera, Inc. (Symbol: NTRA) is a leading diagnostic and research company based in San Carlos, CA, driven by a commitment to advance the science and application of prenatal testing. In the information age, medical diagnostics have lagged behind in adopting new technologies, but Natera is changing that narrative. The company specializes in preconception and prenatal genetic testing services, providing couples with crucial information throughout the pregnancy journey.
Natera offers a comprehensive range of tests, including Preimplantation Genetic Diagnosis (PGD) for IVF and Non-Invasive Prenatal Testing (NIPT). Their Panorama NIPT is particularly notable for its ability to screen for chromosomal abnormalities in a fetus, even in twin pregnancies, typically through a simple blood draw from the mother. Another significant product is the Horizon Carrier Screening (HCS), which determines carrier status for numerous severe genetic diseases that could be passed on to offspring.
The company's innovative approach leverages advances from the Human Genome Project and is powered by proprietary bioinformatics algorithms. This technology enables highly accurate genetic testing results. Natera's portfolio also includes the Signatera Molecular Residual Disease (MRD) Test, designed to detect circulating tumor DNA in cancer patients, helping to assess molecular residual disease and monitor recurrence. Additionally, the Prospera test assesses organ transplant rejection.
Through its pioneering genetic testing services and experienced genetic counseling, Natera provides valuable insights that help in informed decision-making for pregnancies and medical conditions. The company continues to make significant strides in the field of medical diagnostics, driven by a passion for innovation and excellence.
Natera Inc (NASDAQ: NTRA) announced multiple studies to be presented at the 2025 ASCO GI Symposium in San Francisco. Key highlights include data from the BESPOKE CRC study, the largest prospective MRD study in the U.S., which demonstrated Signatera's effectiveness as a prognostic and predictive biomarker in colorectal cancer patients.
The study showed that Signatera-positive patients had significantly inferior outcomes in both stage II (HR=10.4) and stage III patients (HR=10.1). The 24-month disease-free survival rates were 91.7% for Signatera-negative and 41.4% for Signatera-positive patients.
Additionally, Natera will present initial results from their novel tissue-free MRD detection test, showing high sensitivity and specificity, and early cancer detection data with 95% sensitivity and 91% specificity in colorectal cancer detection. The symposium will feature multiple presentations, including a late-breaking oral presentation on the CALGB/SWOG 80702 study.
Natera CEO Steve Chapman has received two significant recognitions in 2024: being named one of the top healthcare technology CEOs by Healthcare Technology Report and 'BioTechnology Innovator of the Year' by BioTech Breakthrough Awards. During his 15-year tenure at Natera, including serving as CEO since 2019, the company has published over 250 peer-reviewed papers and launched 20 products that have transformed patient care.
Under Chapman's leadership, Natera has developed key products including the Signatera™ oncology test, Prospera™ transplant assessment test, and Panorama™ non-invasive prenatal test. The Healthcare Technology Report's annual program recognizes the top 50 CEOs in biotechnology and life sciences, while the BioTech Breakthrough Awards received nominations from over 14 countries globally.
Natera (NASDAQ: NTRA) announced updates to its oncology innovation roadmap at the 43rd Annual J.P. Morgan Healthcare Conference. The company introduced three key developments:
1. A new version of Signatera leveraging whole genome sequencing (WGS), now available for research and clinical use, detecting down to low single-digit parts per million.
2. A novel tissue-free molecular residual disease (MRD) capability, with first launch expected in mid-2025 for colorectal cancer (CRC), utilizing methylation-based technologies.
3. Preliminary data for their Early Cancer Detection (ECD) assay, showing 92% detection of stage 1 CRC and 95% detection overall, with 91% specificity. The company plans to present additional data from the PROCEED-CRC cohort later this year, followed by an FDA-grade validation study if results are positive.
Natera (NTRA) has released preliminary unaudited results for Q4 and full-year 2024, showing significant growth across key metrics. The company expects Q4 2024 revenues of approximately $472 million, up 52% from Q4 2023, and full-year 2024 revenues of approximately $1.7 billion, representing a 56% increase from 2023.
Test volumes showed strong growth, with 792,800 tests processed in Q4 2024 (26.5% increase) and 3,064,600 tests for full-year 2024 (22.8% increase). Notably, oncology testing saw substantial growth, with 150,800 oncology tests in Q4 2024, marking a 54.7% increase. The company achieved positive cash inflows of $45.8 million in Q4 2024 and $86.3 million for full-year 2024, compared to previous year's cash outflows.
Natera (NASDAQ: NTRA), a leading cell-free DNA testing company, has announced its participation in the upcoming 43rd Annual J.P. Morgan Healthcare Conference in San Francisco. The company's management team will deliver a presentation and conduct a Q&A session with investors on Wednesday, January 15, 2025, at 9:00 a.m. PT (12:00 p.m. ET).
Interested parties can access a live webcast of the event through the investor relations section of Natera's website at investor.natera.com. A recording of the presentation will be made available shortly after the conference concludes.
Natera (NASDAQ: NTRA) has expanded its patent infringement lawsuit against NeoGenomics by adding U.S. Patent No. 11,319,596 to the case. The District Court for the Middle District of North Carolina granted Natera's request on December 10, 2024. The amended complaint now includes both the '596 and previously asserted '454 patents, claiming infringement by NeoGenomics' modified RaDaR® test for molecular residual disease. This legal action follows earlier court decisions in December 2023 and September 2024 that resulted in preliminary and permanent injunctions against NeoGenomics' previous version of the RaDaR® test. Natera is pursuing full remedies, including injunctive relief, against NeoGenomics' current RaDaR® test offering.
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.
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