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Natera Launches EDEN Study on Early Risk Assessment for Preeclampsia and Adverse Pregnancy Outcomes
Businesswire· 2026-02-06 11:00
Core Insights - Natera, Inc. has launched EDEN, a large multi-center prospective study to evaluate its non-invasive prenatal screening test for early risk assessment of preeclampsia and other serious pregnancy complications [1] Group 1: Company Overview - Natera, Inc. is a global leader in cell-free DNA and precision medicine [1] Group 2: Industry Context - Preeclampsia affects approximately 5-8% of pregnancies and is a leading cause of maternal and neonatal morbidity [1]
Natera Files Signatera CDx PMA With FDA for Bladder Cancer MRD Test
ZACKS· 2026-02-03 16:30
Key Takeaways Natera filed an FDA PMA for Signatera CDx to guide adjuvant therapy in bladder cancer.Phase 3 IMvigor011 trial showed MRD-positive patients benefit from Tecentriq.Approval could expand Signatera adoption, boost Natera revenue and strengthen its precision oncology position.Natera (NTRA) recently announced the submission of a premarket approval (PMA) application to the FDA for its Signatera CDx test, a personalized molecular residual disease (MRD) assay for patients with muscle-invasive bladder ...
Natera Submits Signatera™ CDx PMA to FDA
Businesswire· 2026-02-02 11:00
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. ...
Prospera™ Featured in Landmark Interventional Study Advancing Lung Transplant Care
Businesswire· 2026-01-26 11:00
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. ...
Lack of Natera (NTRA) Exposure Weighs on Voya MidCap Opportunities Fund Performance
Yahoo Finance· 2026-01-23 15:53
Voya Investment Management’s Voya MidCap Opportunities Fund released its Q4 2025 investor letter, titled “Seeking a More Favorable Risk/Return Trade-off”, outlining a quarter marked by solid market gains but relative fund underperformance. A copy of the letter can be downloaded here. During the quarter, the Fund underperformed its benchmark, the Russell Mid Cap Growth Index, primarily due to unfavorable stock selection, even as U.S. equity markets advanced on moderating inflation, robust earnings, and conti ...
Natera (NTRA) Surged as Results Beat Expectations
Yahoo Finance· 2026-01-20 13:55
Fred Alger Management, an investment management company, released its “Alger Small Cap Focus Fund” fourth-quarter 2025 investor letter. A copy of the letter can be downloaded here. The US equity market ended the fourth quarter on a strong note, with the S&P surging 2.7%, maintaining its steady upward momentum. Investors' optimism was supported by better-than-expected corporate earnings, the US Federal Reserve’s further interest rate easing stance, and a resilient macroeconomic backdrop. Improving clarity on ...
Natera, Inc. (NTRA) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript
Seeking Alpha· 2026-01-14 03:46
Core Insights - Natera's mission is to transform disease management globally through proprietary technology that detects minute quantities of DNA, combining molecular and bioinformatics techniques [2] - The company launched its first product, Panorama, in 2013, a cell-free fetal DNA test for chromosomal abnormalities, and has since become the market leader with over 50% market share [3] - Natera has expanded its technology applications to organ health with Prospera, which non-invasively identifies organ transplant rejection using donor-derived cell-free DNA, and to oncology with Signatera, which monitors minimal residual disease and recurrence through circulating tumor DNA [3]
Natera, Inc. (NTRA) Presents at 44th Annual J.P. Morgan Healthcare Conference - Slideshow (NASDAQ:NTRA) 2026-01-13
Seeking Alpha· 2026-01-14 03:31
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Natera (NasdaqGS:NTRA) FY Conference Transcript
2026-01-14 01:32
Summary of Natera's Conference Call Company Overview - **Company**: Natera - **Industry**: Life Sciences, Diagnostics, Oncology, Women's Health - **Core Mission**: Transforming disease management globally through proprietary technology that detects small quantities of DNA [2][3] Key Products and Market Position - **Panorama**: A cell-free fetal DNA test for chromosomal abnormalities, leading with over 50% market share [2] - **Prospera**: A test for organ transplant rejection using donor-derived cell-free DNA [2] - **Signatera**: A circulating tumor DNA test for minimal residual disease (MRD) monitoring, achieving record growth with 22,000 clinical MRD tests in Q4 [3][4] Financial Performance - **Q4 2025 Revenue**: $660 million, up 39% year-over-year, driven by strong average selling prices (ASPs) and volume growth [4] - **Free Cash Flow**: Exceeded $100 million for the year [5] - **Unit Sales**: 924,000 units in Q4, with significant growth in oncology and women's health [3][4] Innovations and Future Growth Drivers - **Fetal Focus**: A new 21-gene single-gene NIPT test aimed at severe genetic disorders, filling a gap in clinical care [5][6] - **Signatera Enhancements**: Incorporation of phased variants technology for improved sensitivity, targeting a limit of detection (LOD) down to one part per 10 million [10][11] - **AI Integration**: Development of an augmented MRD score using AI and a foundation model to enhance precision in risk assessment [12][13] Clinical Trials and Partnerships - **Clinical Trials**: Significant investments in clinical trials, particularly in breast cancer, with over $100 million allocated for evidence generation [16][17] - **STELLAR Trial**: A pivotal phase three trial in colorectal cancer, leveraging Signatera for patient enrollment [18][35] - **Partnerships**: Collaborations with NVIDIA for AI initiatives and Ultima Genomics for new product launches [22] Market Dynamics and Competitive Landscape - **Market Share**: Natera holds over 50% market share in women's health and is focused on maintaining and expanding its position through innovation and clinical evidence [25][39] - **Lymphoma Market**: Interest in expanding into lymphoma and hematologic cancers, leveraging Foresight Diagnostics' technology [27][28] Regulatory and Reimbursement Strategies - **Medicare Coverage**: Ongoing efforts to expand Multi-X coverage, with 30% of tests currently not covered under Medicare [21] - **Reimbursement Process**: Coordination with MolDX for new assay coverage, emphasizing the importance of generating data [32] Future Outlook - **2026 Goals**: Plans to complete enrollment for the FIND study in early cancer detection and launch new products incorporating advanced technologies [21][22] - **Operating Margins**: Expectation of growing into profitability as revenue matures, with a focus on maintaining operational efficiency [46][48] Conclusion Natera is positioned for significant growth through innovative product offerings, strategic partnerships, and a strong focus on clinical evidence generation. The company aims to leverage its market leadership in diagnostics to expand into new therapeutic areas while enhancing its existing product lines.
Natera (NasdaqGS:NTRA) FY Earnings Call Presentation
2026-01-14 00:30
Natera, Inc. Investor presentation J.P. Morgan Healthcare Conference January 13, 2026 1 Safe harbor statement This presentation containsforward-looking statements under the meaning of the Private Securities Litigation Reform Act of 1995. Allstatements other than statements of historical facts contained in this presentation, including statements regarding our market opportunity, our anticipated products and launch schedules, our reimbursement coverage and our product costs, our commercial and strategic partn ...