In solid tumors, MRD generally refers to minimal/molecular residual disease, which is identified through tumor-derived molecular abnormalities—most commonly circulating tumor DNA (ctDNA). MRD detection enables the identification of residual disease that cannot be detected by conventional imaging modalities, including PET-CT, or by standard laboratory methods, and reflects the potential persistence of malignancy and risk of subsequent clinical progression.

MRD testing may assist clinicians in earlier identification of patients at high risk of recurrence, thereby providing additional information to support post-treatment clinical decision-making.

In recent years, significant advances have been made in MRD detection technologies for solid tumors. Accumulating evidence from multiple clinical studies conducted worldwide suggests that MRD status is strongly associated with recurrence risk in patients with solid tumors, supporting its potential role in prognostic assessment and in informing individualized treatment strategies.

Addressing the challenges associated with selecting appropriate technical strategies for ctDNA-based MRD detection, Genecast has pioneered an integrated MRD detection solution, Genecast MRD MinerVa Prime, designed to balance the needs of both therapeutic guidance and highly sensitive MRD monitoring.

MinerVa Prime leverages WES Prime, a whole-exome sequencing platform specifically developed for pan–solid tumor applications, to comprehensively identify tumor-specific mutations. Key genes involved in critical oncogenic pathways are sequenced at increased depth, enabling simultaneous support for treatment decision-making and MRD assessment.

Based on the mutation profile identified from tumor tissue, up to 50 tumor-informed variants are selected to construct a personalized ctDNA panel for each patient. cfDNA is then analyzed using ultra-deep sequencing (up to 100,000×), enabling highly sensitive detection of ctDNA at very low allele frequencies.

Analytical performance validation demonstrates that Genecast MinerVa Prime achieves a limit of detection as low as 0.0025%, substantially exceeding the sensitivity threshold of 0.02% recommended in the Chinese Expert Consensus on MRD Detection and Clinical Application in Lung Cancer. The assay also shows consistently high specificity, exceeding 99.5%, supporting reliable MRD detection in clinical settings.

Genecast MRD MinerVa Prime has been evaluated in the EVIDENCE cohort, the large-scale, randomized phase III adjuvant clinical trial conducted in a Chinese population of EGFR-positive non–small cell lung cancer patients.

Interim results from this cohort were presented orally at the 2024 World Conference on Lung Cancer. The findings demonstrated that longitudinal ctDNA-based MRD monitoring showed strong predictive value for disease recurrence, with a negative predictive value of 91.3% within the study population. In addition, MRD positivity preceded radiographic evidence of recurrence by a median of 168 days, highlighting the potential of MRD monitoring to enable earlier detection of relapse compared with conventional imaging.

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