Creative Biosciences

Colosafe

Colosafe is the stool DNA test kit for early detection of colorectal cancer. It was the first approved of its kind by NMPA on November 20, 2018. This test can accurately detect and interpret aberrant DNA messages (human SDC2 methylation) from stool samples, enabling physicians to identify cancerous lesions early to prevent the development of colorectal cancer (CRC) at its initial stages. Consequently, the prevention and potential cure of CRC can be achieved. Colosafe has been implemented in over 700 healthcare institutions in China and has gained significant clinical recognition from professionals and experts.

Accurate with high sensitivity& specificity [1][2]

Noninvasive (only 4.5 gram of stool sample) [1]

Complete colorectal detection without blind spot [3]

No bowel preparation in-home sample collection[1]

NMPA approval

CE mark

"Thank you for saving my life"

A participant in a mass community
screening program

Colosafe Clinical Trial Performance

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.

Sensitivity for CRC [2][4]

Stage l-IV

84.22%

(315/374)

Stage I-ll

86.71%

(137/158)

Specificity

97.85%

(821/839)

Biological Principles

Epithelial cells, including tumor cells, exfoliating into the gut lumen

Excreted with stool to be used as a testing sample

Collection and Detection of Human DNA

Achieve early detection of colorectal cancer (CRC)

Detecting mutated DNA from cancer cells

Market Outlook of Colosafe

Presence in 4 continents worldwide

Market entry in 45+ countries

Applied in 700+ clinics in China

1 Million + clinical tests realized

Target Population for Colosafe

Individuals aged 45 and older at average risk. ^[5]

Individuals with GI symptoms such as diarrhea, abdominal pain, bloating, fecal occult blood, constipation, or weight loss. ^[6]

Individuals with no intention of undergoing colonoscopy or at high risk of complications. ^[6]

Individuals with CRC history, family history of CRC, type 2 diabetes, or obesity. ^[6]

Individuals with benign conditions of the rectum and anus, such as hemorrhoids, anal fistulas, anal fissures, and perianal masses. ^[7]

How to Use Colosafe Stool Collection Device

[1]中华医学会检验医学分会分子诊断学组. 早期结直肠癌和癌前病变实验诊断技术中国专家共识[J]. 中华检验医学杂志, 2021, 44(05):372-380.

[2]人类SDC2基因甲基化检测试剂盒（荧光PCR法）,体外诊断试剂产品注册技术审评报告.

[3]Ahlquist D A,Zou H,Domanico M,et al. Next-Generation Stool DNA Test Accurately Detects Colorectal Cancer and Large Adenomas[J]. GASTROENTEROLOGY -BALTIMORE THEN PHILADELPHIA-, 2012.

[4]Wang J, Liu S, Wang H, et al. Robust performance of a novel stool DNA test of methylated SDC2 for colorectal cancer detection: a multicenter clinical study. Clin Epigenetics. 2020;12(1):162.

[5]Swati M S ,Fpm M ,Anderson J C ,et al. Updates on Age to Start and Stop Colorectal Cancer Screening:
Recommendations From the U.S. Multi-Society Task Force on Colorectal Cancer. 2021.

[6]国家消化系统疾病临床医学研究中心(上海), 国家消化道早癌防治中心联盟, 中华医学会消化内镜学分会, 等. 中国早期结直肠癌筛查流程专家共识意见(2019,上海)[J]. 中华内科杂志, 2019, 58(10):736-744.
[7]任东林. 中国痔病诊疗指南(2020)[J]. 结直肠肛门外科, 26(5):15.