Genecast Comprehensive is our NGS-based test of multi-gene mutation detection for breast cancer, colorectal cancer, gastric cancer, gastrointestinal stromal tumor, head and neck squamous cancer, lung cancer, melanoma, ovarian cancer, thyroid cancer and multiple types of solid tumors.
Genecast Comprehensive detects point mutations, Indels, fusions and rearrangements, CNVs, in 769 genes, and determines tumor mutational burden (“TMB”) status, microsatellite instability (“MSI”) status, human leukocyte antigen (“HLA”) typing and PD-L1 expression from FFPE tissue samples and liquid biopsy samples.
Genecast Comprehensive detects:
(i) 87 genes associated with targeted therapy treatment;
(ii) 44 genes and 76 single nucleotide polymorphism (“SNP”) sites associated with 28 chemotherapy drugs and regimens;
(iii) 211 proto-oncogenes and tumor suppressor genes;
(iv) 207 oncogenic driver genes;
(v) 68 cancer susceptibility genes;
(vi) 54 DNA damage repair (“DDR”) genes associated with poly adenosine diphosphate-ribose polymerase (“PARP”) inhibitor targeted therapy;
(vii) 519 loci associated with PD-L1 expression, TMB status and MSI status;
(viii) 40 genes associated with immunotherapies and HLA typing.
It combines genetic testing by sequencing the DNA of FFPE tissue samples and the ctDNA of liquid biopsy samples with analysis against a proprietary database and algorithms, to determine gene mutations and provides the most effective targeted therapy, immunotherapy or chemotherapy recommendation for the patient.
For several types of cancers including breast cancer, colorectal cancer, gastric cancer and lung cancer, Genecast Comprehensive also provides postoperative prognosis for patients.
The testing process of Genecast Comprehensive comprises four major steps, which include sample collection/DNA extraction, library preparation, high-throughput sequencing and bioinformatics analysis. The following diagram illustrates the working process of Genecast Comprehensive.
Our Genecast Comprehensive has the following advantages:
Comprehensive: Genecast Comprehensive covers all genes and sites associated with drugs approved by the FDA and the NMPA, drugs recommended under the NCCN guidelines and drugs under clinical trials for targeted therapies, immunotherapies, and chemotherapies. It also provides real-time information and rich detection content during testing to guide patient treatment.
Accurate: Genecast Comprehensive provides broad coverage and high sequencing depth for cancer related genes to ensure accurate and sensitive detection of critical variants of great clinical significance. Genecast Comprehensive uses optimized variant calling algorithms and integrative bioinformatics pipeline for comprehensive reporting of various types of mutations, such as our proprietary CNV algorithm to effectively identify variations in replication numbers and polyploidy and our unique MSI algorithm. Genecast Comprehensive-based TMB is highly consistent with whole exome sequencing (“WES”) results, and our blood TMB analysis has been validated in clinical study to be a strong predictor of response to immunotherapy in advanced lung squamous cell carcinoma, based on data published in Molecular Cancer. Rigorous quality control has been implemented for the testing process of Genecast Comprehensive.
Evidence-based: The panel used in Genecast Comprehensive was designed to test for genes and loci based on clinical levels of evidence. Genecast Comprehensive provides report interpretation and presentation based on variation and evidence grading of clinical level evidence-based medicine to assist physicians in selecting appropriate treatment regimes. The databases used by Genecast Comprehensive for data interpretation are continuously updated based on new clinical evidence and biomarkers.