Genecast IVD – KNBP, our Core Product and in vitro companion diagnostic kit, is our proprietary multi-gene detection reagent kit.
Genecast IVD – KNBP utilizes an NGS-based genetic testing process to detect single nucleotide variants (“SNVs”) in KRAS, NRAS, BRAF and PIK3CA genes to provide therapy selection for patients with colorectal cancer.
It combines genetic testing by sequencing the DNA of FFPE colorectal cancer tissue with analysis against our proprietary database and algorithm, to determine colorectal cancer gene mutations and provide a targeted therapy recommendation.
Patients with a wild-type KRAS gene detected in their FFPE tissue samples are deemed eligible for cetuximab targeted therapy.
According to Frost & Sullivan, Genecast IVD – KNBP is the first NMPA approved NGS-based companion diagnostic kit indicated only for colorectal cancer commercialized in China and the second worldwide.
Genecast IVD – KNBP is the first NGS-based companion diagnostic kit indicated only for colorectal cancer commercialized in China and the second worldwide, which we believe that it allows us to enjoy significant first-mover advantages. Our Genecast IVD – KNBP has the following advantages:
Accurate: Genecast IVD – KNBP demonstrated an overall sensitivity of 99.18% and an overall specificity of 98.98%.
Comprehensive: The NGS-based Genecast IVD – KNBP provides more comprehensive gene mutation detection of hotspots and rare and unknown variable loci compared to detection by PCR technology.
Highly-Efficient: Genecast IVD – KNBP detects the presence of multigene loci, which saves detection time and sample consumption.