TEST:

ColoScape™ Colorectal Cancer Mutation Detection Test

The primary data has shown that this low cost and rapid turnaround time multiomics assay has a comparable sensitivity for early colorectal cancer diagnostic.

"DiaCarta...announced today that DiaCarta received US FDA 510(k) clearance for it’s over the counter (OTC) at home iColon Fecal Occult Blood Test (FOBT) that enables early detection of blood in stool at home, which is clinically relevant in gastrointestinal disorders and colorectal cancer."

This pilot study was intended to provide performance indicators to design a larger population study that is currently underway. These preliminary findings suggest that liquid biopsy-based mutational and DNA fragment analysis can play a role in selecting subjects with a higher risk of returning a positive colonoscopy, thus potentially improving the quality of colorectal cancer screening programs and patients’ experience.

"The presentations will focus on how XNA can be used to improve the assay sensitivity of different technology platforms such as Sanger sequencing, qPCR, and Next Generation Sequencing (NGS). DiaCarta’s XNA technology has demonstrated improvements to the sensitivity of traditional Sanger sequencing to comparable sensitivity levels of NGS, with much broader clinical utility and lower cost. The XNA-based Sanger sequencing and qPCR are used for sensitive companion diagnostics (CDx) assay development for identification of KRAS G12C mutation."

The preliminary assay clinical specificity and sensitivity were 100% (95% CI: 91.3-100%) and 86% (95% CI: 66-95%) respectively for CRC and 91% specificity (95% CI: 75%-98%) and 60% sensitivity (95% CI: 17%-93%) for advanced adenomas. In summary, the ColoScape test utilizing the XNA-based technology provides high sensitivity and high specificity to CRC and advanced adenomas with a great potential to be used as an early screening test.

ColoScape™ Colorectal Cancer Detection Test is a novel highly-sensitive in vitro diagnostic assay using theqPCR-based multigene panel for the qualitative detection of colorectal cancer-associated gene mutations inliquid biopsy samples. The test targets 61 mutations in 8 genes and 7 methylation markers mostly associatedwith colorectal cancer utilizing our XNA technology which leverages a sequence-specific clamp made by xenonucleic acid (XNA) Target Genes: APC (1309 1367 1450) CTNNB1 (41 45) KRAS (12 13) BRAF 600 TP53 (R273HR175H R248Q) SMAD4 (R361C) PIK3CA (E545K) NRAS G12D Sensitivity for CRC: 88.9% 62.5% for Advancedadenoma Specificity 96%.

The ColoScape test utilizing the XNA-based technology provides high sensitivity and high specificity to CRC and advanced adenomas with a great potential to be used as an early screening test.

ColoScape™ Colorectal Cancer Detection Test is a novel highly-sensitive in vitro diagnostic assay using the qPCR-based multigene panel for the qualitative detection of colorectal cancer-associated gene mutations in liquid biopsy samples. The test targets 61 mutations in 8 genes and 7 methylation markers mostly associated with colorectal cancer utilizing our XNA technology which leverages a sequence-specific clamp made by xeno- nucleic acid (XNA) Target Genes: APC (1309 1367 1450) CTNNB1 (41 45) KRAS (12 13) BRAF 600 TP53 (R273H R175H R248Q) SMAD4 (R361C) PIK3CA (E545K) NRAS G12D Sensitivity for CRC: 88.9% 62.5% for Advanced adenoma Specificity 96%.

"In this study, a total of 380 clinical samples, including plasma cfDNA and FFPE samples from patients with precancerous and different stages of CRC, were analyzed with the ColoScape™ assay. With liquid biopsy the preliminary assay clinical specificity for CRC was 100% and the clinical sensitivity was 92.2%; for precancerous lesions clinical specificity was 95% and clinical sensitivity was 62.5%. With FFPE samples the preliminary assay clinical specificity for CRC was 96% and the clinical sensitivity was 92%, making this assay robust, specific and highly sensitive."

The XNA-mediated molecular clamping assay is a rapid, precise, and sensitive assay for the detection of precancerous lesions cfDNA and CRC cfDNA or FFPE samples.