Announcement • May 28
Myriad Genetics Highlights Data Demonstrating Broad Clinical Utility of Precise Mrd Assay At 2026 Asco Annual Meeting
Myriad Genetics announced it will share data demonstrating the utility of Myriad’s Precise MRD (molecular residual disease) test across diverse cancer types. Myriad will share evidence across six poster presentations showcasing the prognostic power of its ultrasensitive MRD assay. Several of the presentations report interim outcomes from the MONSTAR-SCREEN-3 study. In the presentation, 'Prognostic Impact of MRD Positivity at Ultra-sensitive ctDNA Levels Using a WGS-based Personalized Assay: A Pan-Cancer Analysis from MONSTAR-SCREEN-3,' 97% baseline detection was reported, with 16% of samples detected in the ultrasensitive range. Patients who were ctDNA-positive at one month post-surgery had significantly worse disease-free survival compared to those who were ctDNA-negative, suggesting that post-surgical ctDNA positivity, including at ultrasensitive levels, is strongly prognostic for recurrence risk. Other presentations focused on ovarian cancer, gastric cancer, head and neck cancer, and sarcoma also demonstrate the emerging clinical utility of ctDNA as a biomarker of recurrence and therapy response. Detecting ctDNA at very low levels consistently across multiple tumor types demonstrates that sensitivity truly matters. Precise MRD may enable a new standard in which ultra-sensitive detection translates directly into earlier, more confident clinical decision-making. Attendees can meet at the Industry Expert Theater #1 on Sun., May 31 from 9:30 to 10:30 am CDT for an introduction to the Precise MRD Test. The session will cover assay technical details and the clinical evidence across multiple solid tumors, including breast and colorectal cancers, and explore the role of highly sensitive MRD detection in oncology. Myriad presentations include: Poster 64, abstract 4081: Whole-Genome Sequencing-Based Ultra-sensitive ctDNA Molecular Residual Disease Assessment in Resectable Gastric Cancer: Results from MONSTAR-SCREEN-3; Poster 181, abstract 3044: Prognostic Impact of Positivity at Ultra-sensitive ctDNA Levels Using a WGS-based Personalized Assay: A Pan-Cancer Analysis from MONSTAR-SCREEN-3; Poster 523, abstract 6066: Clinical Validation of Ultra-Sensitive WGS-based MRD Detection in Head and Neck Squamous Cell Carcinoma: Results from MONSTAR-SCREEN-3; Poster 270, abstract 5604: The Use of Circulating Tumor DNA to Stratify the Risk of Recurrence After Surgical Debulking in Epithelial Ovarian Cancer; Poster 334, abstract 11544: Ultra-Sensitive Whole-Genome Sequencing-Based Molecular Residual Disease Detection in Resectable Sarcoma in MONSTAR-SCREEN-3; Poster 501, abstract 10540: Association between physical activity and molecular residual disease clearance in postoperative cancer patients: The SCRUM-MONSTAR LIFELOG study. Myriad tests to be highlighted at the booth include: Precise MRD (Molecular Residual Disease) Test is a tumor-informed assay that uses whole genome sequencing (WGS) to achieve ultra-sensitivity. This unique assay enables the custom selection of up to 1,000 targeted variants for deep analysis. It has impressive limits of detection and sensitivity. The test can be used to monitor circulating tumor DNA (ctDNA) levels throughout a patient’s clinical cancer care, starting immediately after diagnosis and continuing through treatment and surveillance. MyRisk Hereditary Cancer Test with RiskScore combines genetics, clinical factors (Tyrer-Cuzick), and polygenic risk to uncover insights that gene testing alone may not provide, helping offer more information to support patient decisions in breast cancer risk assessment and management. Prolaris + AI Prostate Cancer Prognostic Test is the first and only prostate cancer biomarker test to unite clinical-pathological features, an independent molecular score, and independent AI-powered digital pathology technology from Myriad’s partnership with PATHOMIQ AI. The booth will also feature Myriad’s Biopharma services which are utilized for working in conjunction with Biopharma partners to advance drug development programs from biomarker discovery through CTA, CDx development, worldwide regulatory approval and global commercialization. MyChoice CDx is the only FDA-approved homologous recombination deficiency (HRD) test specifically mentioned in ASCO guidelines for selecting patients with ovarian cancer who may benefit from PARP inhibitors. By determining comprehensive HRD status, the MyChoice CDx Test helps expand access to targeted therapy in both early and late-line settings. MSK-ACCESS is a comprehensive liquid biopsy test developed by Memorial Sloan Kettering Cancer Center (MSK). The test offers noninvasive cancer genomic profiling and disease monitoring using cell-free DNA (cfDNA) obtained from blood and other body fluids. The test is currently available for use in conjunction with Myriad’s Pharma partnerships for CTA development and CDx utilizing Myriad’s partnership with SOPHiA GENETICS. MSK-IMPACT is a solid tumor test for comprehensive genomic profiling (CGP) which delivers high-resolution profiling of complex biomarkers from DNA and RNA in a single, end-to-end workflow. The test is currently available for use in conjunction with Pharma partnerships for CTA development and CDx utilizing Myriad’s partnership with SOPHiA GENETICS. The MONSTAR-SCREEN-3 is a prospective multicenter study targeting more than 1,100 patients with solid tumors undergoing curative-intent treatment. Personalized panels were constructed using Precise MRD, incorporating up to 1,000 tumor-specific alterations identified through WGS of matched tumor tissue. Serial plasma samples were collected at baseline, post-neoadjuvant treatment (NAT) (when applicable), 1-month (1M) post-surgery, every 3 months in year 1, and every 6 months thereafter up to 2 years. Assay performance was evaluated across multiple cancer types for ctDNA detection and recurrence monitoring. The Precise MRD test provides molecular insights across the cancer care continuum. After diagnosis, the test can help clinicians determine if adjuvant treatment is needed, or if cancer has recurred. Should cancer metastasize in a patient, Precise MRD can provide molecular insights showing whether treatment is working or if a patient’s ctDNA is increasing. For baseline tests, a personalized panel is developed based on a whole-genome sequencing profile of tumor tissue, and then the panel is used to measure the ctDNA level from an initial blood draw. For ongoing monitoring, the panel measures ctDNA levels from samples collected with a frequency based on where patients are in the treatment process. Clinicians will receive an easy-to-read report that shows whether ctDNA was detected or not. If ctDNA is detected, the concentration of ctDNA is reported, which allows clinicians to see historical results of the patient’s ctDNA concentration over time.
