What is the purpose of ColoClear?
ColoClear is a non-invasive and painless at-home stool-based FIT-DNA test for colorectal cancer screening. ColoClear is the only approved colorectal cancer screening test by the National Medical Products Administration (NMPA). There have accurate results with a 99.6% negative predictive value3 and 96% sensitivity3 for colorectal cancer, clinically validated in Asian population studies3.
Who can use ColoClear?
This test is particularly beneficial for people aged over 40 who are at average or higher risk for colorectal cancer. This includes, but is not limited to individuals who have:
- A family history of colorectal cancer
- A medical history of malignant colorectal tumours
- Previously suffered from intestinal polyps
- A medical history of appendicitis and/or an appendectomy
- Symptoms affecting the bowels (e.g. diarrhoea, constipation, bloating, bloody stool), including younger individuals (above age 18)
Why should I get screened?
According to the American Cancer Society, colorectal cancer is an abnormal growth of cells in the colon or rectum that can invade nearby tissues or spread to other organs. Normally, colorectal cancer starts as a polyp (small growth) that gets larger over time. Nearly 1 in 5 individuals have a colorectal polyp. These growths are usually benign but some polyps can grow into cancer. It is estimated that colorectal cancer polyps need to take 5-10 years for forming in a colorectal cancer. As long as you should develop a habit of regular screening, early diagnosis improves the survival in colorectal cancer.
How accurate is ColoClear? What is the sensitivity and specificity of the ColoClear test?
ColoClear has a negative predictive value of 99.6% and 99.5% true positive rate for colorectal cancer. ColoClear can also detect advanced adenomas, which are more advanced growths compared to polyps but the growths are not considered to be cancer. However, these growths can grow into cancer. The sensitivity for advanced adenomas for ColoClear is measured separately and is 63.5%. ColoClear’s overall specificity (the true negative for no cancer or advanced adenomas) is 87.1%.
How to interpret ColoClear test negative and positive results?
A “Negative”test result indicates that based on the sample, no colorectal cancer lesions have been detected, and there is a low possibility of colorectal cancer or precancerous polyps. A “Positive” test result indicates that a signal for colorectal cancer lesions have been detected in the stool sample. We encourage customers to consult a doctor to follow up on the results.
What are the advantages of ColoClear compared to a colonoscopy or sigmoidoscopy?
ColoClear is a non-invasive screening option you can use at home for detection of colorectal cancer and benign neoplasia. Unlike a colonoscopy or sigmoidoscopy, there is no special preparation needed for ColoClear. No changes to your diet or medication is necessary prior to collecting your stool sample. You do need to take time off for the test nor take a leave for colonoscopy at the clinic or hospital. ColoClear includes delivery to your doorstep and you can collect your sample in the privacy of your own home. It also includes door-to-door sample returns which you can schedule easily after activation of your collection kit.
What is a FIT-DNA test?
FIT-DNA is a next generation DNA technology that combines advanced Stool DNA technology and traditional fecal immunochemical (FIT) technology. It looks for signs of blood in stool (faeces) and for abnormal DNA that could be a sign of cancer or polyps. FIT-DNA test is capable of detecting multiple biomarkers and haemoglobin.
What are the difference of ColoClear compared with The The Government’s Colorectal Cancer Screening Programme?
The Government’s Colorectal Cancer Screening Programme only subsidises asymptomatic Hong Kong residents aged between 50 to 75 to receive screening service for colorectal cancer. Participants will first take an Occult Blood Test that detect small amounts of blood in stool, even if they are invisible to the naked eye. However, occult blood test also has its own limitation and may not be 100% accurate. If occult blood test result is positive, the patient need to be assessed by colonoscopy. Where polyps are found, they will be removed for analysis. On the contrary, ColoClear is easy to use, less invasive compared with a colonoscopy, and results can be ready in shorter time.
In addition, The Government’s Colorectal Cancer Screening Programme is not subsidises Hong Kong residents who aged below 50. Hong Kong incidence of colorectal cancer among younger individuals has been marked by a continual increase, including the age group who aged 40 or above. Regular screening test is the key to prevent colorectal cancer and finding it early.
When should I not use ColoClear?
You should not use a ColoClear test kit if you are experiencing any of the following conditions:
- Menstrual bleeding
- Diarrhoea and/or watery stool
- Gastrointestinal/rectal bleeding (e.g. actively bleeding haemorrhoids)
The conditions listed above increase the likelihood of stool sample contamination with traces of blood and/or abnormal cells that are not necessarily due to colorectal cancer. Therefore, it is best not to take this test under these conditions.
Individuals who have been diagnosed with the following conditions should not use ColoClear:
- Familial Adenomatous Polyposis (FAP)
- Crohn's disease
- Inflammatory Bowel Disease (IBD) including Chronic Ulcerative Colitis (CUC)
How often do patients need to be tested? How often do I need to use ColoClear for regular screening?
The American Cancer Society recommends a screening interval every 3 years following a negative colorectal cancer screening result from a stool-based DNA test.
In certain high-risk individuals, including those with a family history of colorectal cancer, any inherited mutations, or other known risk factors, screening is recommended to begin at an earlier age than the recommended age of 45. For stool-based tests, the ACS recommends regular screening every 1-3 years. For more information on your personal risk for colorectal cancer, please consult your doctor.
References：
1. Hong Kong SAR. Centre for Health Protection, Department of Health. (2022). Colorectal Cancer. https://www.chp.gov.hk/tc/healthtopics/content/25/51.html
2. Hong Kong SAR. Centre for Health Protection, Department of Health. (2020). Non-Communicable Diseases Watch - Fighting Colorectal Cancer. https://www.chp.gov.hk/files/pdf/ncd_watch_january_2020.pdf
3. People's Rupublic of China. National Medical Products Administration. (2020). 体外诊断试剂产品注册技术审评报告: CSZ2000050.
