For Providers
TEST |
DESCRIPTION |
SENSITIVITY |
SPECIFICITY |
||
| COLORECTAL CANCER | ADVANCED ADENOMAS | ||||
ColoScapeTM |
ColoScape™ is a novel multigene mutation biomarker qPCR-based assay for qualitative detection of colorectal cancer (CRC) associated somatic mutations in the genes that are frequently mutated in colorectal cancer subjects and are responsible for aberrant colonic epithelial cell proliferation. (detects 61 mutation in 8 genes and 7 methylation markers) |
≥88.9% |
62.5% |
≥96% |
|
|
ColoGuard® |
ColoGuard® is an FDA approved test (2014) for colorectal cancer by checking gene mutations and methylations from stool DNA it detects two DNA methylation markers [NDRG4, BMP3], mutations on K-ras gene, and fecal hemoglobin
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5108981/# |
92% |
42% |
87% |
|
|
Epi procolon® |
Epi proColon is a plasma DNA test for detection of a biomarker, methylated Septin9, associated with colorectal cancer. Church, Timothy Robert et al. “Prospective evaluation of methylated SEPT9 in plasma for detection of asymptomatic colorectal cancer.” Gut vol. 63,2 (2014): 317-25. doi:10.1136/gutjnl-2012-304149 |
48% |
11% |
91% |
|
ColoScapeTM Colorectal Cancer Detection Test
Colorectal cancer is the third most common cancer in the world and in the U.S. In 2022 an estimated 151,030 adults in the United States will be diagnosed with colorectal cancer.
According to the American Cancer Society, the guideline for colorectal screening is to start the colorectal cancer screening at age 50 (most recent changes to age 45). However, among the 98 million Americans aged 50 to 84, one-third of them are not screened for colorectal cancer for different reasons.
Source: American Cancer Society
Target genes |
APC (1309, 1367, 1450) | CTNNB1 (41, 45) | KRAS (12, 13) | BRAF 600 | TP53 (R273H, R175H, R248Q) |
| SMAD4 (R361C) | PIK3CA (E545K) | NRAS G12D | |||
Methylation markers |
KCNQ5 | C9Orf50 | MYO1G | FLI1 | CLIP4 |
| ZNF132 | TWIST1 |
ColoScapeTM Colorectal Cancer Mutation Detection Test
ColoScapeTM Colorectal Cancer Mutation 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 and FFPE tissue 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)
*ColoScapeTM assay is CE-marked outside of US. It has not been cleared by FDA and it is intended to be used for research purpose only in the US