Molecular Residual Disease (MRD)
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Natera to Present 14 Studies at ESMO, Including IMvigor011 Oral Presentation in Presidential Symposium
Businesswire· 2025-10-12 22:10
Core Insights - Natera, Inc. is showcasing its technology at the European Society for Medical Oncology (ESMO) Congress, with 14 studies presented, including six oral presentations that emphasize its leadership in molecular residual disease (MRD) testing across various cancer types [1][2]. Bladder Cancer Highlights - The IMvigor011 trial, sponsored by Genentech, will present data on Signatera's predictive capabilities for disease-free survival (DFS) and overall survival (OS) in muscle-invasive bladder cancer (MIBC) [2]. - The CheckMate 274 trial results indicate that DFS for Signatera-positive patients treated with nivolumab was 7.4 months compared to 2.8 months for placebo, with a hazard ratio of 0.35, highlighting the effectiveness of MRD-guided treatment [3]. Additional ESMO Data - Other oral presentations will cover results from the SunRISe-4 trial in MIBC, the INTERCEPT trial in colorectal cancer, and Natera's early cancer detection program, showcasing the breadth of research utilizing Signatera [4]. Expert Commentary - Experts emphasize that Signatera MRD can identify bladder cancer patients likely to benefit from adjuvant immunotherapy, aiming to improve treatment outcomes and change medical practices [5]. Presentation Schedule - A detailed schedule of presentations featuring Natera's technology at ESMO includes various studies on bladder cancer, colorectal cancer, and breast cancer, with specific dates and presenters listed [6][7][8][9][10][11].
Myriad Genetics Announces Precise MRD Clinical Data Published in The Lancet Oncology
Globenewswire· 2025-09-04 23:00
Core Insights - Myriad Genetics announced the publication of a study in The Lancet Oncology, showcasing the effectiveness of its Precise MRD test for patients with oligometastatic clear-cell renal cell carcinoma (ccRCC) [1][4] Study Findings - The study aimed to assess the benefits of ultrasensitive MRD testing in oligometastatic ccRCC patients, revealing that circulating tumor DNA (ctDNA) levels correlate with responses to metastasis-directed radiation therapy (MDT) [2][3] - The Precise MRD test successfully detected ctDNA in patients with low tumor burden, potentially allowing them to delay or avoid systemic treatments, thus reducing side effects and enabling treatment de-escalation [2][3] Key Metrics - In the Phase 2 trial, patients who were ctDNA negative experienced nearly double the median systemic therapy-free survival compared to ctDNA positive patients [3] - 94% of patients tested at baseline had ctDNA levels below 100 ppm, indicating the effectiveness of the ultrasensitive testing [7] - Patients who tested negative for ctDNA maintained MDT for a median of 54 months, while those who tested positive progressed to systemic therapy within a median of 27 months [7] - Overall survival rates for ctDNA negative patients on MDT were 94% at two years and 87% at three years [7] Test Overview - Myriad's Precise MRD Test utilizes whole genome sequencing to monitor numerous tumor-specific variants, providing high sensitivity and quantification of ctDNA in cancer patients [5] - The test can be employed throughout a patient's clinical journey, starting from diagnosis and continuing through treatment [5] Company Background - Myriad Genetics specializes in molecular diagnostic testing and precision medicine, aiming to enhance health and well-being through advanced genetic and genomic testing solutions [8]
Myriad Genetics Shares New Clinical Data Demonstrating Sensitivity of Precise MRD Across Multiple Cancer Types
Globenewswire· 2025-06-02 13:00
Core Insights - Myriad Genetics announced new clinical data from the MONSTAR-SCREEN-3 study, demonstrating the effectiveness of its ultra-sensitive Precise™ MRD Test in detecting circulating tumor DNA (ctDNA) across various cancer types [1][2] - The study achieved 100% baseline detection of ctDNA and found that 60% of patients testing positive one month post-surgery had ctDNA levels only detectable via the ultra-sensitive test [2] Study Findings - The MONSTAR-SCREEN-3 study involved approximately 1,200 patients across more than 20 cancer types, focusing on the application of MRD monitoring using Precise MRD [3] - The study aims to provide high-quality clinical evidence for the broad application of MRD testing, particularly in low-shedding tumors [3] - ctDNA levels are assessed at multiple time points, including diagnosis, post-neoadjuvant therapy, and post-surgery, with follow-ups every 3-6 months for at least two years [3] Test Details - Myriad's Precise MRD test is a tumor-informed, whole-genome sequencing (WGS)-based test that monitors hundreds to thousands of tumor-specific variants, offering exceptional sensitivity in ctDNA detection [4][5] - The test can detect tumor fractions as low as 0.0001% (1 part per million) and has shown a clinically meaningful lead time in detecting recurrence compared to imaging [5] Clinical Implications - The results indicate that ctDNA status after neoadjuvant treatment is strongly associated with pathological response, highlighting the potential for personalized treatment strategies [2][5] - The enhanced sensitivity of the Precise MRD test allows for better monitoring and treatment planning for patients with low-shedding tumors, such as breast and renal cancers [2][4]