Myriad Genetics announced significant clinical data for its Precise MRD (minimal residual disease) test at the American Association for Cancer Research (AACR) Annual Meeting, demonstrating the test's effectiveness in patients with oligometastatic clear-cell renal cell carcinoma (ccRCC).
The data, presented by Dr. Chad Tang from The University of Texas MD Anderson Cancer Center, highlights how the ultrasensitive circulating tumor DNA (ctDNA) detection technology could serve as a valuable biomarker for treatment decisions in a cancer type that traditionally lacks reliable prognostic markers.
Breakthrough in Personalized Treatment for Oligometastatic Renal Cancer
The Phase 2 trial examined metastasis-directed radiotherapy without systemic therapy (MRWS) for oligometastatic ccRCC patients while investigating ctDNA as a personalized biomarker. This approach represents a potential paradigm shift in treatment, as MRWS offers substantial advantages over more aggressive frontline systemic therapies.
"This study demonstrated that metastasis-directed radiation therapy can help patients delay or avoid systematic treatments without sacrificing outcomes. Overall survival was not compromised, with survival rates of 94% at two years and 87% at three years," said Dr. Tang, associate professor in the department of genitourinary radiation oncology at MD Anderson.
The study revealed a striking correlation between Precise MRD test results and treatment outcomes. Patients who tested negative on the Precise MRD test maintained on metastasis-directed therapy for a median of 54 months, while those testing positive required systemic therapy within a median of 27 months.
Overcoming Technical Challenges in ctDNA Detection
Oligometastatic ccRCC presents unique challenges for MRD assays due to tumor heterogeneity, slow growth rates, low ctDNA shedding, and limited trackable mutations. Myriad's ultrasensitive ctDNA MRD assay addresses these challenges by employing large, tumor-informed panels capable of detecting very low ctDNA levels.
Dale Muzzey, chief scientific officer at Myriad Genetics, emphasized the significance of these findings: "In this study, our ultrasensitive MRD assay identified more than 50% of patients as MRD-positive at their baseline visit, which is impressive given that the very low tumor fractions common in ccRCC are often below the detection limits of first-generation MRD tests."
This improved sensitivity has direct clinical implications. "Many of these patients may have gotten false negatives if tested on earlier MRD assays, and that is clinically meaningful because MRD positivity in this study was associated with substantially longer duration prior to the initiation of more aggressive systemic therapy," Muzzey added.
Additional Research Highlights Advanced Technical Capabilities
In addition to Dr. Tang's podium presentation, Myriad showcased two posters at AACR highlighting technical advancements in their MRD testing approach:
The first poster demonstrated how Myriad's Precise MRD test uses a novel ranking algorithm to select up to 1,000 high-confidence targets based on tumor-specific and target-specific features, optimizing panel design for residual disease detection.
The second poster revealed that including insertion/deletion (INDEL) mutations in tumor-informed, patient-specific panels increases the likelihood of detecting low abundance ctDNA, achieving higher sensitivity at low tumor concentrations.
Implications for Future Cancer Care
The performance of Precise MRD in this challenging clinical setting suggests potential applications across various cancer types. By accurately identifying patients who might benefit from less aggressive treatment approaches, the test could help avoid unnecessary side effects and reduce healthcare costs.
Precise MRD is currently available for use in research studies pursued jointly by Myriad and academic or pharmaceutical investigators. The company continues to develop the assay to meet the needs of cancer patients, academic partners, and biopharma companies, with ongoing evaluation in several high-impact studies.
About Myriad's Precise MRD Test
Myriad's Precise MRD test is a tumor-informed, whole genome sequencing (WGS) based test that monitors hundreds to thousands of tumor-specific variants. This enables exceptional sensitivity and quantification of ctDNA in the blood of cancer patients. The test can be used throughout a patient's clinical care, from diagnosis through treatment.
The test is performed at Myriad's state-of-the-art laboratory facility in Salt Lake City, as part of the company's broader portfolio of advanced genetic and tumor genomic testing solutions designed to meet the unique needs of oncology specialists and their patients.
