Myriad Genetics Shares New Clinical Data Demonstrating Sensitivity of Precise MRD Across Multiple Cancer Types

Rhea-AI Summary

Myriad Genetics (MYGN) revealed promising clinical data from the MONSTAR-SCREEN-3 study for their Precise MRD Test, demonstrating 100% detection of circulating tumor DNA (ctDNA) at baseline across multiple cancer types. The study, conducted with Japan's National Cancer Center Hospital East, showed the test can detect tumor fractions as low as 0.0001% and successfully created personalized whole-genome sequencing panels for 97.3% of patients. Notably, 60% of ctDNA-positive patients one month post-surgery had ultra-low tumor fractions only detectable by Precise MRD's enhanced sensitivity. These patients showed significantly worse disease-free survival compared to ctDNA-negative patients. The test also demonstrated ability to predict pathological complete response during neoadjuvant chemotherapy and showed earlier recurrence detection compared to imaging.

Positive

• Achieved 100% baseline detection of ctDNA across multiple tumor types
• Successfully created personalized WGS panels for 97.3% of patients
• Demonstrated ultra-high sensitivity detecting tumor fractions as low as 0.0001%
• Showed earlier detection of cancer recurrence compared to traditional imaging
• Proved ability to predict treatment response in neoadjuvant chemotherapy

Negative

• Patients testing positive for ctDNA one month after surgery showed significantly worse disease-free survival

Insights

Oncology Research Specialist

Myriad's Precise MRD test shows exceptional cancer detection sensitivity, potentially outperforming first-generation tests with significant clinical implications.

Myriad Genetics' Precise MRD Test has demonstrated remarkable clinical performance in the MONSTAR-SCREEN-3 study. The test achieved 100% baseline detection of circulating tumor DNA (ctDNA) across multiple cancer types, including traditionally difficult-to-detect low-shedding tumors. This represents a significant technical achievement in liquid biopsy diagnostics.

What's particularly notable is the test's ultra-sensitivity, detecting tumor fractions as low as 0.0001% (1 part per million). Among ctDNA-positive samples one month post-surgery, 60% had levels in an ultra-sensitive range that would likely be missed by first-generation MRD tests. Importantly, these patients showed significantly worse disease-free survival, highlighting the clinical relevance of this enhanced sensitivity.

The study also demonstrated the test's ability to predict pathological complete response based on ctDNA clearance during neoadjuvant chemotherapy. This suggests potential applications in treatment response monitoring, allowing for earlier intervention or therapy adjustment.

The personalized whole-genome sequencing approach, tracking up to 1,000 somatic variants, is central to achieving this sensitivity level. This methodology provides a key technical advantage over first-generation tests that track fewer variants, especially in cancers like breast and renal that traditionally have low ctDNA shedding.

These results position Myriad's Precise MRD as potentially superior to existing MRD tests in the growing liquid biopsy market, with possible applications across multiple cancer types for treatment selection, recurrence monitoring, and response assessment.

MONSTAR-SCREEN-3 study showed 100% detection of circulating tumor DNA (ctDNA) at baseline timepoint, and 60% of patients testing positive one month after surgery had tumor fractions only detectable via ultra-sensitive MRD

SALT LAKE CITY, June 02, 2025 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, today announced new molecular residual disease (MRD) clinical data from the MONSTAR-SCREEN 3 study, a collaboration with the National Cancer Center Hospital East (NCCHE) in Japan, demonstrating successful pan-cancer implementation of Myriad’s ultra-sensitive Precise™ MRD Test to detect and monitor ctDNA in patients.

The interim results – first shared at the 2025 ASCO Annual Meeting by Tadayoshi Hashimoto, MD, PhD of the NCCHE – achieved 100% baseline detection of ctDNA across tumor types, including those traditionally challenging to assess because of low levels of ctDNA in blood. Key findings include:

• Personalized whole-genome sequencing (WGS) panels utilizing up to 1,000 somatic variants were successfully created via Precise MRD for 97.3% of patients tested.
• Precise MRD detected tumor fractions as low as 0.0001% (1 part per million) and showed a clinically meaningful lead time in detecting recurrence compared to imaging.
• Clearance of ctDNA during neoadjuvant chemotherapy, as shown by Precise MRD, predicted pathological complete response.
  

“Previous studies have shown that ctDNA-based MRD detection significantly correlates with recurrence risk and predicts benefit of adjuvant chemotherapy in certain cancers,” said Takayuki Yoshino, MD, PhD of the NCCHE and principal investigator for the MONSTAR-SCREEN-3 study. “However, first-generation MRD assays appear to have limited sensitivity in low ctDNA-shedding tumors. For our pan-cancer study, we selected Precise MRD because of its enhanced sensitivity across diverse tumor types.”

“Our results showed that among samples that were ctDNA-positive at the one-month post-surgery timepoint, 60% had ctDNA levels in the ultra-sensitive range that may not have been reported as positive by first generation MRD tests,” said Dr. Hashimoto. “In addition, these patients had significantly worse disease-free survival compared to those that were ctDNA-negative, demonstrating the importance of ultra-sensitive ctDNA detection.”

“The initial results from the study highlight the tremendous potential for utilizing Precise MRD across cancer types to enhance personalized treatment and therapeutic strategies for patients,” said Dale Muzzey, PhD, chief scientific officer, Myriad Genetics. “Precise MRD is informed by WGS, enabling the tracking of thousands of tumor-specific sites, far more than what is possible with first-generation MRD tests. Tracking so many variants yields exceptional sensitivity even in cancers with low shedding tumors such as breast and renal. A key benefit of our ultrasensitive assay is confidence in ctDNA results, as shown by the finding that the ctDNA status after neoadjuvant treatment was strongly associated with pathological response.”

About the Study
The SCRUM-MONSTAR-SCREEN-3 study explores how multi-omic profiling, including MRD, can be used to develop more personalized treatment and therapeutic strategies in three study cohorts. Approximately 1,200 patients across more than 20 cancer types are undergoing MRD monitoring via Precise MRD as part of the study. The goal of SCRUM-MONSTAR-SCREEN-3 is to generate high-quality, prospective, clinical evidence showing that MRD testing can be broadly applied across cancer types, including many that are “low-shedding,” and to patients with different stage of extent of disease. ctDNA levels are being assessed at diagnosis, post-neoadjuvant therapy, post-surgery, and every 3-6 months thereafter for ≥2 years.

About Myriad’s Precise MRD Test
Myriad’s Precise MRD test is a tumor-informed, WGS-based test that monitors hundreds to thousands of tumor-specific variants, enabling exceptional sensitivity and quantification of ctDNA in the blood of patients with cancer. The Precise MRD test can be used to monitor ctDNA levels throughout a cancer patient’s clinical care, starting immediately after diagnosis and continuing through treatment.

Precise MRD is available for use in research studies pursued jointly by Myriad and academic or pharmaceutical investigators. Myriad continues to develop its Precise MRD assay to meet the needs of patients with cancer, academic partners, and biopharma companies. The test is currently being evaluated in several high-impact studies and is performed at the company’s laboratory facility in Salt Lake City.

About Myriad Oncology
Myriad Oncology™ provides a portfolio of advanced genetic and tumor genomic testing solutions, including risk assessment, screening, tools to aid treatment guidance, and survivorship. The Myriad Oncology offering is designed to meet the unique needs of oncology specialists and their patients across each step in the patient care continuum.

About Myriad Genetics 
Myriad Genetics is a leading molecular diagnostic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad Genetics develops and offers molecular tests that help assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where molecular insights can significantly improve patient care and lower healthcare costs. For more information, visit www.myriad.com.

Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the initial study results highlighting the tremendous potential for utilizing Precise MRD across cancer types to enhance personalized treatment and therapeutic strategies for patients, and the Company’s continued development of its Precise MRD assay to meet the needs of patients with cancer, academic partners, and biopharma companies. These “forward-looking statements” are management’s expectations of future events as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially and adversely from those anticipated. Such factors include those risks described in the company’s filings with the U.S. Securities and Exchange Commission, including the company’s Annual Report on Form 10-K filed on February 28, 2025, as well as any updates to those risk factors filed from time to time in the company’s Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. Myriad is not under any obligation, and it expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise except as required by law. 

Investor Contact 
Matt Scalo 
(801) 584-3532 
IR@myriad.com 

Media Contact 
Kate Schraml
(224) 875-4493
PR@myriad.com  

FAQ

What are the key findings of Myriad Genetics' MONSTAR-SCREEN-3 study for their Precise MRD Test?

The study showed 100% baseline ctDNA detection across cancer types, created successful WGS panels for 97.3% of patients, detected tumor fractions as low as 0.0001%, and demonstrated earlier recurrence detection compared to imaging.

How does MYGN's Precise MRD Test compare to first-generation MRD tests?

Precise MRD shows enhanced sensitivity, detecting ultra-low tumor fractions that may not be reportable by first-generation tests, with 60% of positive post-surgery samples being in the ultra-sensitive range.

What is the clinical significance of Myriad Genetics' Precise MRD Test results?

The test can predict pathological complete response during chemotherapy, detect cancer recurrence earlier than imaging, and identify patients with worse disease-free survival through post-surgery ctDNA detection.

How does MYGN's Precise MRD Test work?

The test uses personalized whole-genome sequencing panels tracking up to 1,000 somatic variants, enabling detection of tumor-specific sites across various cancer types, including those with low ctDNA shedding.

What cancer types can Myriad Genetics' Precise MRD Test detect?

The test demonstrated effectiveness across multiple cancer types, including traditionally challenging ones with low ctDNA shedding such as breast and renal cancers.