Circle ColoClear

ColoClear by Circle

Colorectal Cancer Screening Test

Non-invasive, FIT-DNA screening test for detecting early signs of colorectal cancer using at-home sample collection.

Early screening is your first line of defense

Colorectal cancer is one of the most preventable cancers - when caught at an early stage up to 90% of cases are treatable.² Nearly 1 in 5 individuals have a colorectal polyp. These growths are usually benign but some polyps can grow into cancer.³ Polyp detection and resection can prevent colorectal cancer from developing.

Colorectal cancer is the second most common cancer

Hong Kong recorded 5,566 colorectal cancer cases in 2019, making it 15.8% of all cancer cases. The risk of colorectal cancer also increases significantly with age.⁴

Colon health made easy with ColoClear

ColoClear combines advanced Stool DNA technology and the Faecal Immunochemical Test (FIT) which results in 96% sensitivity for colorectal cancer.

Stool DNA Technology

This advanced DNA technology ensures highly accurate results by analysing multiple genetic mutations that contribute to the complex development of colorectal cancer. This way, pre-cancerous polyps and signs of colorectal cancer can be effectively detected at various stages. The Stool DNA technology is based on studies looking at DNA mutations and methylations patterns. Multiple studies have compared the genetic make up of malignant growths in colorectal cancer patients with the cells shed by healthy individuals. The results from these studies have indicated a strong correlation between certain DNA biomarkers and an increased risk for developing colorectal cancer.⁶

FIT Technology

A traditional FIT tests for traces of blood, which can be caused by colorectal cancer and/or polyps. However, polyps may not always bleed and for this reason the sensitivity of a FIT test for colorectal cancer ranges from 73% to 82%⁷ when compared to a colonoscopy.

How does colorectal cancer form?

The lining of the colon is a very dynamic tissue where old and dead cells are replaced with new cells every day. Over time, this high cell renewal rate can cause polyps to develop and some might grow uncontrollably, resulting in cancer.

What do your ColoClear results mean?

A positive result indicates that a signal for colorectal cancer lesions has been detected in the stool sample. You will likely need to plan a follow-up colonoscopy with your healthcare provider.

A negative 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.

96% sensitivity and a 99.6% negative predictive value¹

Developed and clinically tested by a team of experts, ColoClear is the only test approved by the National Medical Products Administration (NMPA) for colorectal cancer screening.
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The test's accuracy is based on a clinical study involving 4,245 individuals¹, tailored to the Asian population.

Instructional Leaflet

Sample Collection Pad

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Gloves

Shipping Envelope

Specimen Bag

Sampling Spoon

Technology

ColoClear combines advanced Stool DNA technology and Fecal Immunochemical Test (FIT) which results in 96% sensitivity for colorectal cancer.

DNA Stool Technology

FIT Techology

Detection

How does colon cancer form?

What do your ColoClear results mean?

A positive result indicates that a signal for colorectal cancer lesions has been detected in the stool sample. You will likely need to plan a follow-up colonoscopy with your healthcare provider.

A negative 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.

Accuracy

96% sensitivity and a 99.6% negative predictive value¹

What’s included

Instructional Leaflet

Sample Collection Pad

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Gloves

Padded Envelope

Specimen Bag

Spoon

Where to get ColoClear

If you’d like to get a ColoClear testing kit, please contact the clinics below to get your test from a physician.

Got questions? Get answers.

Check out our frequently asked questions below, or contact us for more information.

What is ColoClear?

ColoClear is an at-home, non-Invasive stool collection kit for detection of colorectal cancer and benign neoplasia.

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)

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.
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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 does ColoClear work?

The ColoClear kit includes two test tubes that each perform a different test.

One test extracts the DNA from your stool, and tests against certain biomarkers indicative of the presence of colorectal cancer and/or pre-cancerous polyps.

The other test is a standard Faecal Immunocolloid Test (FIT) that detects traces of blood in your stool, which can be indicative of colorectal cancer.

The DNA test detects altered DNA such as mutations that can indicate pre-cancerous polyps and/or colorectal cancer. A Faecal Immunocolloid Test (FIT) tests for traces of blood, which can be caused by colorectal cancer and/or pre-cancerous polyps. However, polyps or growths that bleed may not bleed all the time. For this reason, the sensitivity of a FIT test for colorectal cancer ranges from 77% - 94% when compared to screening for colorectal cancer using a colonoscopy.

The combination of these two tests increases the sensitivity for colorectal cancer detection to up to 96% by testing for multiple biomarkers.

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. Not all polyps are cancerous, but some do turn into cancer.
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Colorectal cancer is the second most common cancer in Hong Kong, making up 15.8% of all cancer cases.* Early detection of colorectal cancer increases chances of full recovery. ColoClear combines existing technology with the latest developments to bring you a test that detects cancerous and pre-cancerous biomarkers in your stool. It is easy to use, less invasive compared with a colonoscopy, and results can be ready in 5 business days.
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*According to Center for Health Protection Hong Kong

Where can I buy the test kit?

At the moment, ColoClear is available for purchase at selected clinics. For more details on these clinics: Locations and Contact Details

Is ColoClear covered by insurance?

ColoClear is not covered by insurance at the moment. However, we are working closely with different insurance companies for partnership opportunities.

Is ColoClear available outside Hong Kong?

At the moment, we do not deliver ColoClear testing kits outside of Hong Kong. However, we are working to expand our testing efforts and will directly share any updates on our website hicircle.com/coloclear

How does stool DNA technology work?

Every day, your colon sheds cells that line the inside of the colon. As part of this process, any growths that are made up of altered cells will shed into the colon along with normal cells.When you have a bowel movement, cells are collected by the stool as it passes through your colon.
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This advanced DNA technology ensures highly accurate results by analysing multiple genetic mutations that contribute to the complex development of colorectal cancer. This way, pre-cancerous polyps and signs of colorectal cancer can be effectively detected at various stages. The Stool DNA technology is based on studies looking at DNA mutations and methylations patterns. Multiple studies have compared the genetic make up of malignant growths in colorectal cancer patients with the cells shed by healthy individuals. The results from these studies have indicated a strong correlation between certain DNA biomarkers and an increased risk for developing colorectal cancer.

What is a FIT-DNA test?

FIT-DNA is a next generation DNA technology that combines advanced Stool DNA technology and traditional faecal 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 is the difference between FIT, FOBT, FIT-DNA test and a colonoscopy?

The faecal immunochemical test (FIT) uses antibodies to detect blood in the stool, which can be an early sign of cancer. FIT only detects human blood from the lower intestines.

A faecal occult blood test (FOBT) takes a sample of your stool (faeces) to check for blood. It uses the chemical guaiac to detect blood in the stool. Occult blood means that you cannot see it with the naked eye.

FIT-DNA is a next generation DNA technology that combines advanced Stool DNA technology and traditional faecal 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.

A colonoscopy is an exam used to detect changes or abnormalities in the large intestine (colon) and rectum. If necessary, polyps or other types of abnormal tissue can be removed through the scope during a colonoscopy. Tissue samples (biopsies) can be taken during a colonoscopy and (small) growths, polyps, can be removed as well.

How accurate is ColoClear? What is the sensitivity and specificity of the ColoClear test?

For screening tests, the Negative Predictive Value is generally a good indicator for understanding the clinical relevance and is also known as a “true negative” or “specificity”. ColoClear has a Negative Predictive Value of 99.6% for colorectal cancer. This means that a negative test result indicates a 99.6% chance that one is free of colorectal cancer.
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The sensitivity indicates the true positive rate and for ColoClear the sensitivity is 95.5% for colorectal cancer. In other words, ColoClear test can detect 95.5% of the colorectal cancer patients, like a colonoscopy will detect the presence of colorectal cancer.
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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%.
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ColoClear’s overall specificity (the true negative for no cancer or advanced adenomas) is 87.1%.

How does ColoClear compare to other available tests?

ColoClear has a higher sensitivity rate when compared to other faecal DNA tests that are approved for clinical use [source].

ColoClear is not a diagnostic test and is designed for screening purposes only. The result cannot be interpreted as a diagnosis for colorectal cancer. ColoClear can be an alternative for a colonoscopy that is intended for screening purposes. Please consult your primary healthcare provider to learn more.
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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. However it does not guarantee the absence of colorectal cancer and/or advanced adenomas.
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A “Positive” test result indicates that a signal for colorectal cancer lesions have been detected in the stool sample, but does not guarantee the presence of these conditions when a colonoscopy is performed as a follow-up procedure.

What are the advantages of ColoClear compared to a colonoscopy/sigmoidoscopy?

ColoClear is a non-invasive screening option you can use at home. Unlike a colonoscopy or sigmoidoscopy, there is no special preparation needed for ColoClear. You will not need to take time off for the test nor stay at least half a day 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. No changes to your diet or medication is necessary prior to collecting your stool sample.

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.

The Hong Kong Cancer Expert Working Group (CEWG) recommends colorectal cancer screening every 1-2 years (faecal occult blood test) depending on your physician's advice.

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.

Can ColoClear detect polyps and/or early stage cancer?

ColoClear is intended for use as an adjunctive screening test for the detection of colorectal cancer and benign neoplasia. A positive result suggests a high probability for the colonoscopy to find significant lesions including colorectal cancer, advanced adenomas or benign neoplasia. The patient with a positive ColoClear result is recommended to follow up with a diagnostic colonoscopy for confirmation. A negative result indicates that there is a low possibility of a colorectal cancer or an advanced adenoma (adenomatous polyps with more advanced pre-malignant features).

Can I speak to someone to help interpret my results?

When you purchase from selected clinics, a healthcare professional from the clinic will guide you through how to interpret your results. Your results will be shared with your clinic when ready and a representative from the clinic will reach out to you for the next steps. Locations and Contact Details

Can I speak to anyone before making a purchase?

You may schedule a consultation with our partner clinics before making a purchase.

re:HEALTH (For more information: visit their website)

Mong Kok Branch
11/F, Langham Place Office Tower, 8 Argyle Street, Mong kok
Contact number: (852) 2156 5856
Business Hours:
Monday 9:00am - 7:00pm
Tuesday to Saturday 8:15am - 7:00pm
Closed on Sundays and public holidays

Causeway Bay Branch
Room 3401 - 3403, 34/F, World Trade Centre, No. 280 Gloucester Road,
Causeway Bay
Contact number: (852) 2152 8582
Business Hours:
Monday to Saturday 8:30am - 6:00pm
Closed on Sundays and public holidays

Can the test find out if someone has cancer?

ColoClear is an adjunctive screening test for the detection of colorectal cancer and benign neoplasia. A positive result does not necessarily indicate that you have cancer. We encourage customers to consult a doctor to follow up on the results.

Can this test replace a colonoscopy?

ColoClear is not a diagnostic test and is designed for screening purposes only. The result cannot be interpreted as a diagnosis for colorectal cancer. ColoClear can be an alternative for a colonoscopy that is intended for screening purposes. Please consult your primary healthcare provider to learn more.

Have more questions?

ColoClear Colorectal Cancer Screening Test

The importance of colorectal cancer screening