COLOTECT™ 3.0
Non-invasive Test for Colorectal Cancer Screening
OFFICIAL AND EXCLUSIVE
UK DISTRIBUTOR FOR COLOTECT
BOWEL CANCER
Sensitivity for colorectal
cancer is 96.08%1.*
Sensitivity for advanced
precancerous lesions is 52.5%1.*
* Advanced precancerous lesions including advanced adenoma (tubular adenoma measuring ≥ 1 cm in greatest diameter, or adenoma with significant villous features), large serrated lesions or high-grade dysplasia.
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​ while sacrificing some specificity. Our results suggest that this novel multi-target fecal based test may be used as an effective tool for early detection and pre-screening of CRC.
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Easy and Discreet
Sample collection process is designed with privacy and convenience in mind. Customers can collect stool samples in the comfort of their homes and mail samples back to the processing laboratories.
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Combined testing technology increases rate of detection of colorectal cancer
The multi-biomarker DNA and FIT combined testing technology increases rate of detection of colorectal cancer and pre-cancerous lesions, offering ideal performance for colorectal cancer early screening.
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Painless
Non-invasive and painless test uses stool samples to perform early detection of colorectal cancer and does not require bowel preparation.
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Biomarkers Tested
Multiplex methylation specific PCR to detect abnormally methylated CRC marker genes ─ ADHFE1, OPLAH,FIT.
Stool collection instruction
COLOTECT 3.0
96.1%
52.5%
The novel multi-target fecal DNA test exhibited notably superior sensitivity for both CRC and advanced adenoma cases than the commercially quantitative FIT test,
FIT (OC-CHEK)
85.8%
22.5%
COLOTECT vs FIT https://meetings.asco.org/abstracts-presentations/215948
Certification
COLOTECT 3.0 has obtained
CE CE-IVDD /CE-IVDR certification 1/8/23
MHRA Registration 17963
MHRA Reference Number: 17963
Date Registered: 30/08/2021
Manufacturer Address:
BGI Europe A/S
Symfonivej 34
Herlev
Denmark
2730
ISO 13485:2016 certification CE certification
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UK Responsible Person
SUNGO Certification Company Limited
Representative Address:
3rd Floor, 70 Gracechurch Street
London
England, United Kingdom
EC3V 0HR
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UK distributer
Little OX Ltd
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Intended Use and Important Risk Information:
The Combined Detection Kit for Human Gene Methylation and Fecal Occult Blood is a non-invasive in vitro diagnostic (IVD) assay for qualitative detection of certain genes’ methylation and fecal hemoglobin from human stool specimens. The kit is intended to be used for screening colorectal cancer in the general population. A positive test result indicates that the subject may have colorectal cancer and/or advanced adenoma, and further colonoscopy is required; on the contrary, a negative test result indicates that the subject has a low possibility of colorectal cancer and/or advanced adenoma, however, the risk of disease cannot be completely ruled out. The product is applicable to all people between the ages of 40 to 75 who need colorectal cancer screening.
This product cannot replace colonoscopy, and the test results of this kit should not be used as the only basis for clinical diagnosis. Clinicians should comprehensively judge the results based on the patient's condition and other laboratory indicators. CE marked.
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Customer/Physician orders test and Colotect is shipped out
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Customer collects stool samples at home
Customer books online for collection, Fedex ships stool samples back to the processing laboratory
Laboratory conducts testing and generates report