Genecast MRD – Lung is our NGS-based large panel molecular residual disease (“MRD”) detection test that provides postoperative prognosis, risk assessment of recurrence and efficacy evaluation of adjuvant treatment for NSCLC.
Genecast MRD – Lung is the first MRD detection test launched in China.
Genecast MRD – Lung uses a fixed panel of 769 genes and adopts a tumor-informed strategy by sequencing the primary tumor tissue and leveraging the mutational signature derived from the primary tumor to identify patient-specific somatic mutations and track the personalized mutation signatures through our proprietary bioinformatics analysis.
NSCLC patients can periodically be assessed by conducting Genecast MRD – Lung to detect MRD, monitor recurrence and evaluate the efficacy of adjuvant treatment.
Genecast MRD – Lung detects MRD based on 769 genes in DNA extracted from FFPE tissue samples and ctDNA from liquid biopsy samples.
It combines genetic testing by sequencing the DNA or ctDNA with analysis against our proprietary database and algorithm MinerVa platform, to determine gene mutations of NSCLC and detect the presence of MRD to provide postoperative prognosis, risk assessment of recurrence and efficacy of evaluation adjuvant treatment for NSCLC patients.
Genecast MRD – Lung utilizes our MinerVa platform, which is based on the high–sensitivity and high–specificity MRD detection of ctDNA in the blood of tumor patients to track and assess small residual tumors for prognosis and monitoring.
Our MinerVa platform uses a large fixed panel in order to fully cover tumor mutation-related pathways, including oncogenic driver mutations, drug resistance mutations, clonal mutations and passenger mutations in ctDNA.
Primary tumor tissue samples are sequenced to identify patient specific mutation signatures.
Blood samples are sequenced at a depth of more than 30,000x for MRD analysis by our proprietary bioinformatics pipeline which uses a probability model against a background database built upon data collected from over 1,000 negative plasma samples for technical noise suppression in order to achieve ultra-low frequency mutation detection.
The sample level ctDNA status is determined by joint confidence calculation combining all variants from the patient-specific mutation profile.
Our MinerVa platform exhibited a sample-level LoD as low as 0.008% at a specificity of greater than 99.5% in analytical performance verification. LUNGCA, our ongoing multi-center prospective cohort study, confirms Genecast MRD – Lung has beneficial clinical value in postoperative prognosis, risk assessment of recurrence and efficacy evaluation of adjuvant treatment of NSCLC.
According to data recently published in Clinical Cancer Research, LUNGCA has the largest cohort in the world for MRD studies in lung cancer.
Genecast MRD – Lung is the first MRD service launched in China and one of eleven MRD testing services for commercial sale in China. For details, see “Industry Overview — Part VI: Prognosis and Monitoring — Competitive Landscape” in this prospectus. Our Genecast MRD – Lung has the following advantages:
Fully validated fixed large panel: Genecast MRD – Lung uses a fixed large panel of 769 genes and adopts a tumor-informed strategy to identify patient-specific somatic mutations and track the personalized mutation signatures in the patient’s blood through liquid biopsy.
Breadth and depth of comprehensive mutation tracking: The fixed large panel of 769 genes used in Genecast MRD – Lung provides comprehensive coverage of genes on cancer-related pathways in the entire human genome, and thereby enriches the mutations to be tracked for MRD detection. In addition, the panel was designed with our proprietary algorithm for assigning different boosting weights to intensify depth coverage in specific tumor driver hot spots for ultra-sensitive tracking of clonal driver mutations and key resistance mutations. The detection limit of Genecast MRD – Lung reaches as low as 0.1% for EGFR driver mutations. Exploiting the combined probability model with multiple variants tracked for each patient, Genecast MRD – Lung exhibited 100% detection rate at ctDNA fraction of 0.01% at a specificity over 99.5% in analytical validation.
Unique algorithm to ensure detection accuracy: A baseline background noise database based on thousands of tumor negative blood plasma samples combined with multi-locus joint confidence probability analysis ensures accurate detection results.
Strong clinical evidence: Genecast MRD – Lung is validated through our ongoing clinical study, LUNGCA, which has the largest cohort in the world for MRD studies in lung cancer. The previously published results in Clinical Cancer Research demonstrated that Genecast MRD – Lung-based perioperative MRD status is a strong predictor for disease relapse with a hazard ratio (“HR”) of 11.1, at a statistical significance of P<0.001, and that MRD has a significantly higher relative contribution to relapse-free survival (“RFS”) prediction than all studied clinicopathological variables including cancer TNM stage.