Methylation Detection Kit for Human SDC2 Gene
(Real time PCR) & Stool Collection Device
Brief Introduction of Colosafe®
Full name of Colosafe® is Methylation Detection Kit for Human SDC2 Gene (Real time PCR) & Stool Collection Device which is the first NMPA approved stool DNA test kit for colorectal cancer. Colosafe® entered the special approval channel of National Medical Products Administration in March 2017 and was cleared by NMPA on Nov 20, 2018. It is a product that can precisely detect and interpret the mutated messages (human SDC2 methylation) from stool for detection of colorectal cancer to help physicians to figure out the cancerous lesion early and prevent the development of CRC at early stage. Thus, the prevention and cure of CRC is achieved. It has been implemented in over 700 hospitals in China and has gained tremendous clinical recognition by the professionals and experts.
The sensitivity of Colosafe® to early colorectal cancer is 86.71%
Note: n=1213，CRC=374，non-CRC=839: Kappa=0.85， Kappa>0.75, means high consistency compared with golden standards of colonoscopy and pathology.
Individuals at average risk and age 40-74
Individuals with gastroenterological symptoms like diarrhea, abdominal pain, boating, fecal occult blood, constipation, emaciation
Individuals who had CRC or need follow-ups after tumor resection
Individuals who have family history of CRC
Individuals who have benign diseases of rectum and anus such as hemorrhoid, anus fistula, perianal tumor, anal fissure
Individuals who have no intension or have high risk in undergoing colonoscopy
Guideline and Publication
The Expert Consensus on Colorectal Cancer Screening Protocol in China (in 2019, Shanghai).
Robust performance of a novel stool DNA test of methylated SDC2 for colorectal cancer: a multi-center clinical study
Chinese Experts Consensus On Experimental Diagnosis of Colorectal Cancer in Precancerous Lesions and Early stage
Sample Collection Video