Genecast IVD - KNBP is our proprietary multi-gene detection reagent kit, utilizing capture-based targeted DNA NGS to detect SNVs in KRAS, NRAS, BRAF and PIK3CA genes to provide therapy selection for patients with CRC. 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 CRC commercialized in China and the second worldwide.
We completed a clinical trial for Genecast IVD - KNBP in October 2020 and obtained NMPA approval for Genecast IVD - KNBP in February 2021 as a Class III medical device.
Competitive Advantages
Genecast IVD - KNBP is the first NGS-based companion diagnostic kit indicated only for CRC 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.