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ColoClear Addresses the Unmet Need

ColoClear is a non-invasive screening test for Colorectal Cancer (CRC), equipped with novel FIT-DNA technology to detect both precancerous and cancerous polyps in average1,2 to higher risk3 individuals. With ColoClear, patients are free to conduct the test on their own time, in the comfort of their own home, and with minimal preparation required. These elements allow ColoClear to provide an alternative screening method that is less intimidating, more affordable, and more convenient for the end user, thereby increasing acceptance and overall adherence to prevailing CRC screening guidelines.

In most parts of the world, the detection of haemoglobin in stool samples via FIT technology is the most widely recommended screening tool, and is the first level of screening offered under the current Hong Kong government-funded CRC screening programme4. However, precancerous and cancerous polyps in the colon may only bleed intermittently if at all5, which directly inhibits the ability of the FIT test to accurately detect CRC signals.

ColoClear applies stool DNA technology and FIT screening, which not only detects haemoglobin in the stool, but also multiple cancerous DNA biomarkers in intestinal cells. This multi-target DNA analysis increases the sensitivity of the product at all stages of CRC disease progression3, especially in the early stages when it is potentially most treatable.

Your first step in colon health

What It Detects
Sensitivity
Method
How It Works
Cost
Convenience
Multiple human DNA biomarkers and haemoglobin
High sensitivity and high negative predictive value
Painless at-home collection of stool sample
Sample collection in the comfort of your home
Receive report in 5 business days
FIT
Haemoglobin (blood)
High specificity, low sensitivity
Painless at-home collection of stool sample
Blood detection in stool sample
gFOBT
Haemoglobin (blood)
Low specificity, low sensitivity
Painless at-home collection of stool sample
Requires adjustments in diet to eliminate certain foods
Blood detection in stool sample
Colonoscopy
Polyps and malignant growths
Invasive diagnostic gold standard
Invasive internal visualisation of the colon
Requires adjustments in diet for 2-3 days
Need to take laxatives and fast night before procedure
Procedure conducted under anaesthesia

What it Detects

Multiple human DNA biomarkers and haemoglobin

Sensitivity

High sensitivity and high negative predictive value

Method

Painless at-home collection of stool sample

How it Works

Sample collection in the comfort of your home
Receive report in 5 business days

Cost

Convenience

FIT
Haemoglobin (blood)
High specificity, low sensitivity
Painless at-home collection of stool sample
Blood detection in stool sample
Colonoscopy
Polyps and malignant growths
Invasive diagnostic gold standard
Invasive internal visualisation of the colon
Requires adjustments in diet for 2-3 days
Need to take laxatives and fast night before procedure
Procedure conducted under anaesthesia

What sets ColoClear even further apart from the competition is the sensitivity of the technology to Asian population. Large prospective clinical trials have been conducted in over 4,700 people of Asian ethnicity under NMPA review3, providing a validated test to detect CRC signals specific to the Asian market when compared to foreign competitors.

How Does ColoClear Compare to FIT, FOBT, and Colonoscopy?

ColoClear does not diagnose colorectal cancer nor is it intended to replace colonoscopy as the gold standard for CRC detection. It is a non-invasive screening tool that aims to provide a simple and convenient screening method for average risk patients. The ease and convenience of the ColoClear test kit will be able to detect CRC in the at-risk population at an earlier and potentially more treatable stage. Compared to other screening technologies in the market today like FIT and gFOBT, ColoClear’s FIT-DNA technology has been shown in clinical studies to have the closest CRC and Advanced Adenoma sensitivity to colonoscopy standards and will identify more advanced cancers earlier in their development3. However, the slightly lower specificity implies that 8-11% more patients may have to undergo a diagnostic colonoscopy when compared to rival FIT and FOBT technologies.

Sensitivity = True Positive / (True Positive + False Negative) *100%;
Specificity = True Negative / (True Negative + False Positive) *100%;
Positive Predictive Value (PPV) = True Positive / (True Positive + False Positive) *100%;
Negative Predictive Value (NPV) = True Negative / (True Negative + False Negative) *100%

Who Should Use ColoClear? Who Should Not?

ColoClear is indicated for use by individuals at average or higher risk for colorectal cancer. This includes, but is not limited to, individuals with the following conditions:
  • A family history of colorectal cancer6
  • A medical history of malignant colorectal tumours6
  • Previously suffered from intestinal polyps6
  • 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)
The ColoClear test kit is not recommended for use if you have been diagnosed with any of the following conditions*:
  • Familial Adenomatous Polyposis (FAP)7
  • Crohn's disease7
  • Inflammatory Bowel Disease (IBD) including chronic ulcerative colitis (CUC)7
You should not perform a ColoClear test if you meet any of the following conditions*:
  • You are menstruating at the time of collecting the sample
  • You are (temporarily) suffering from diarrhoea or watery stool
  • You are (temporarily) suffering from gastrointestinal bleeding (e.g. actively bleeding haemorrhoids)

*The situations 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 not advisable to test with ColoClear during these situations.

National Guidelines and Credentials

ColoClear is the only non-invasive colorectal cancer screening test approved by the National Medical Products Administration8 (NMPA). It employs advanced FIT-DNA technology for the detection of both cancerous and precancerous growths as well as advanced adenomas through all stages of the cancer development process. The technology is also recommended by the US Preventive Services Task Force1 for screening and is included as a part of standard care guidelines according to the American Cancer Society2.

ColoClear’s test performance was evaluated with a large prospective clinical trial for colorectal involving eight key hospitals across China. The trial enrolled 5,881 subjects in total between the ages of 40 and 74, including 4,758 evaluable subjects.

ColoClear was determined to have a sensitivity of 95.5% and specificity of 87% when screening for colorectal cancer, and a sensitivity of 64% and specificity of 87% when screening for advanced adenomas. Overall, ColoClear is reported to have a 99.6% NPV when compared to a reference colonoscopy3.
Technology
Detection
Accuracy
What’s included

How it works

Simple steps to get your test done
1
Perform Consultation
During the consultation, the physician will inform the patient of the various screening options including ColoClear. If the patient chooses to move forward with ColoClear, a nurse will collect all relevant patient information on the HCP portal and help the patient activate their kit.
man standing in blue button-down shirt
2
Sample Collection
A third party courier service is included with each ColoClear kit to ensure that the sample is received by the lab as efficiently as possible. Before the patient collects their sample, they must either scan the QR code in the instruction manual or visit the sample return website to directly book their pick-up time through the courier.

Afterwards, the patient will follow the included instructions to collect their stool sample. At the agreed upon time, the courier will collect and transport the sample to the Prenetics lab.

Note: pick-up must be completed within 48 hours of sample collection to maintain sample integrity.

step 4 image
3
Receive Result
After receipt, the Prenetics lab will process the sample within five working days and issue the result report to the physician via the HCP portal.
(Sample reports)

After reviewing the result, the physician can release the report to the patient and contact them directly to set up a follow-up consultation.
References
  • Davidson, Karina W., et al. “Screening for Colorectal Cancer.” JAMA, vol. 325, no. 19, 2021, p. 1965., https://doi.org/10.1001/jama.2021.6238.
  • “Colorectal Cancer Guideline: How Often to Have Screening Tests.” American Cancer Society, 17 Nov. 2020, https://www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/acs-recommendations.html.
  • People's Republic of China. National Medical Products Administration. (2020). 体外诊断试剂产品注册技术审评报告: CSZ2000050.
  • “Eligibility of Colorectal Cancer Screening Programme Updated.” GovHK, 30 Dec. 2021, https://www.info.gov.hk/gia/general/202012/30/P2020123000566.htm. Accessed 17 May 2022.
  • Kim NH, Park JH, Park DI, et al. Risk Factors for False Fecal Immunochemical Test Results in Colorectal Cancer Screening. J Clin Gastroenterol. 2017; 51(2):151-159. https://pubmed.ncbi.nlm.nih.gov/27380459/
  • Ding KF et al. Expert consensus on early diagnosis and treatment of colorectal cancer in China.  Natl Med J China 2020; 100(22): 1691-1698. DOI: 10.3760/cma.j.cn112137-20190924-02103.
  • People with the herementioned illness/disorder were excluded in the ColoClear clinical study under the Exclusion Criteria.
  • “国家药品监督管理局数据查询 - Nmpa.gov.cn.” National Medical Products Administration, 9 Nov. 2020, https://www.nmpa.gov.cn/datasearch/home-index.html.
Note

    ColoClear’s testing accuracy has been clinically validated in over 4700 adults aged between 40-74 years old at high risk of CRC. The 2020 Chinese CRC early prevention Expert Committee consensus statement recommends sFIT-DNA test can be used to screen average risk individuals.