Circulating Tumor DNA (ctDNA)
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Largest Published Study of Molecular Residual Disease (MRD) in Stage III Colon Cancer Shows Guardant Reveal Blood Test More Precisely Identifies Risk of Recurrence After Surgery to Support Timely Treatment Decisions
Businesswire· 2026-02-02 13:05
Core Insights - Guardant Health, in collaboration with Mayo Clinic, published the largest study to date on circulating tumor DNA (ctDNA) for minimal residual disease (MRD) detection in resected stage III colon cancer patients, indicating that ctDNA detection is a better predictor of recurrence and overall survival compared to standard staging [1][2] Group 1: Study Findings - Approximately 20% of patients in the phase III trial had detectable ctDNA post-surgery, with Guardant Reveal identifying a four-to-six-fold higher rate of disease recurrence or reduced survival [2] - Patients with smaller tumors or fewer affected lymph nodes also showed over a six-fold higher rate of events when ctDNA was detected, supporting the integration of ctDNA testing into routine postoperative management [2][4] Group 2: Clinical Implications - The amount of ctDNA, known as tumor fraction, further distinguishes patients at the highest risk of early recurrence and worse survival, aiding clinicians in prioritizing intensive surveillance or alternative therapies [3][4] - ctDNA testing enhances the accuracy of estimating cancer recurrence risk, allowing for more tailored recommendations for adjuvant chemotherapy and follow-up monitoring [4] Group 3: Company Overview - Guardant Health is a leading precision oncology company focused on providing insights into disease drivers through advanced blood and tissue tests, real-world data, and AI analytics, aiming to improve outcomes across all stages of cancer care [5] - The company has expanded its Reveal test to support late-stage therapy response monitoring, reinforcing its clinical utility in molecular residual disease and personalized care [4]
Haystack Oncology and Rutgers Cancer Institute Collaborate in a Clinical Study to Examine Haystack MRD as a Guide for Post-Surgical Treatment for Lung Cancer
Prnewswire· 2025-09-22 12:07
Core Viewpoint - Haystack Oncology, a subsidiary of Quest Diagnostics, has initiated a research collaboration with Rutgers Cancer Institute to evaluate the Haystack MRD test for optimizing postoperative therapy in patients with stage II/III non-small cell lung cancer (NSCLC) [1][2]. Group 1: Research Collaboration and Study Details - The collaboration aims to assess the use of the Haystack MRD test, a highly sensitive circulating tumor DNA (ctDNA) test, to guide postoperative therapy decisions [1]. - The MRD-PORT Trial (NCT06979661) is a prospective phase II study that will determine if the presence of residual tumor DNA after surgery can inform the use of radiation and systemic therapies [1][2]. - Patients testing positive for ctDNA post-surgery will be considered for adjuvant radiation and systemic therapies based on tumor biology and clinical context [2]. Group 2: Importance of ctDNA Testing - ctDNA MRD tests are increasingly recognized for their potential to identify residual or recurring cancer in patients with solid tumors [3]. - A study published in NEJM in April 2025 indicated that ctDNA testing using Haystack MRD identified clinical complete response at a median of 1.4 months, significantly faster than imaging tests which took over 6 months [3]. - A survey revealed that 96% of oncologists believe MRD testing can detect cancer recurrence earlier than current methods [3]. Group 3: Context of Lung Cancer - Lung cancer remains the leading cause of cancer-related deaths in the U.S., with high recurrence rates in stage II and III NSCLC patients [4]. - Studies indicate that patients who test positive for ctDNA after surgery experience significantly worse progression-free survival and overall survival compared to those who test negative [4]. Group 4: Company Background - Haystack Oncology has over 20 years of collaboration in advancing liquid biopsy technologies and developed the Haystack MRD test, which detects ultralow levels of ctDNA [5][6]. - The test is available for commercial use as a lab-developed test (LDT) by Quest Diagnostics and is also utilized in clinical trials as an investigational device [6].
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]