09 June 2022 | Thursday | News
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Test sensitivity of 96% in colorectal cancer and 64% in advanced adenoma detection in clinical studies
- ColoClear is the only cancer screening test approved by the National Medical Products Administration (NMPA)
HONG KONG, June 9, 2022 /PRNewswire/ -- Prenetics Group Limited (Nasdaq: PRE), a global leader in genomic and diagnostic testing, has introduced a novel, non-invasive, at-home screening test – ColoClear by Circle (ColoClear), for detecting early signs of colorectal cancer. Colorectal cancer is the second most common cancer in Hong Kong, accounting for 15.8% of total new cancers in 2019. Combining advanced stool DNA technology with a faecal immunochemical test (FIT), the revolutionary test is the first line of defense against one of the most preventable cancers, which can be treated in 90% of cases when detected early.
ColoClear has been launched in partnership with New Horizon Health (HKEX: 6606), a biotechnology pioneer in the early detection of cancer screening tools. The novel screening test, uses advanced technology to detect multiple DNA biomarkers and blood cells in human stool.
In the ColoClear clinical studies, a total of 4758 subjects were validated in eight clinical institutions in China. The age subjects were between 40 to 75 with a mean of 55.69±8.69 and 46.26% of subjects were male.
Among all patient samples, 605 cases of colorectal cancer and 375 cases of advanced adenoma were confirmed by colonoscopy and/or pathological examination. Clinical trial results showed that the sensitivity of the ColoClear was 95.54% (95%CI: 93.89%, 97.18%), including 96.8% Stage I, 97.5% Stage II, 96.2% Stage III and 96.4% for Stage IV CRC. The assay also demonstrated 63.47% (95%CI: 58.59%, 68.34%) sensitivity for advanced adenoma; the screening specificity for colorectal cancer and advanced adenoma was 87.08% (95%CI: 86.00%, 88.16%); and Negative Predictive Value of colorectal cancer screening was 99.6% (95%CI: 99.2%, 99.7%). Given Coloclear's strong test performance, it is the only cancer screening test approved by the National Medical Products Administration (NMPA).
Mr. Danny Yeung, CEO and Co-Founder of Prenetics stated, "We are extremely excited with the launch of ColoClear in Hong Kong, enabling an easy alternative to Colonoscopy. ColoClear will play a key role in helping to reduce cases and mortality from colorectal cancer in the city. ColoClear is a clear scientific breakthrough that can be expanded across Southeast Asia, with a population of more than 600 million people. As in the case with Cologuard in the USA, working with insurance companies would have a major impact on adoption and we have begun discussions with large regional insurance companies."
"New Horizon Health and Prenetics share the same vision in healthcare. Prevention and early detection, home-based healthcare, and individualized service have become the major trends in the war on cancer around the globe. We have confidence that with our joint efforts, ColoClear will become a benchmark for Asian innovation, raising awareness in cancer screening while saving many lives," said Mr. YeQing Zhu, CEO of New Horizon Health.
Lifestyle factors associated with a busy city like Hong Kong, such as lack of regular exercise, a diet low in fruit and vegetables, and alcohol consumption may contribute to an increased risk of colorectal cancer. According to the Hong Kong Cancer Registry of the Hospital Authority, colorectal cancer has been ranked among the top two high-incidence cancers in Hong Kong since 2012, while being the second most common cause of cancer death. About one in every 6 to 7 new cancer patients suffers from colorectal cancer. More than half of detected cases are found in late stage with a low survival rate. However, if it is found at an early stage, colorectal cancer has a survival rate of over 90%.
In conjunction with the launch in Hong Kong, Prenetics has teamed up with Mr Alex Fong, actor and ex-Olympian swimmer to spread awareness and urgency for people to get screened for colon cancer.
Due to Alex's acting career, he has an extremely busy work schedule, often eating at irregular hours and making it difficult to follow healthy eating habits. As a result, he has been paying extra attention towards his gut health and started doing colonoscopies in the past few years.
"Every time before the colonoscopy procedure, I had to adjust my diet 2-3 days in advance, take laxatives and fast the night before. I would also need to undergo anaesthesia during the procedure at hospital, which is inconvenient and difficult due to my busy schedule. With ColoClear, colorectal cancer screening can be so simple and convenient. I'm so proud such a technology is now available in Hong Kong so people can easily conduct a highly accurate screening test without leaving their home, giving them a peace of mind while looking after their personal health," said Alex Fong.
Prenetics is partnering with leading medical groups in Hong Kong to make colorectal cancer screening accessible and convenient to the Hong Kong people. The test is priced at HKD3,000. Individuals can visit the official website (www.hicircle.com/coloclear) to book a physical or virtual medical consultation with Prenetics' partner clinics, and collect the stool sample in the comfort of their own homes. Upon sending the sample via courier for laboratory testing, users will receive their results within five business days.