M3 BACTERIAL GENE MARKERS TEST TECHNOLOGY

WORLD'S FIRST NON-INVASIVE Colorectal Cancer Risk Prediction Test that detects non-advanced adenoma and adenoma recurrence with HIGH SENSITIVITY

Colorectal cancer (CRC) has been the commonest and second deadliest cancer in Hong Kong since 2013. Most CRCs develop from small polyps (see figure) that are treatable but often undetected.

Various non-invasive tests for CRC are currently available in the market, but they fail to address the need in detecting small polyps for preventative care.

FIT (fecal immunochemical test), the most common of these tests, has a sensitivity of just 7.6% for small polyps. The stool DNA test, one of the newest CRC screening tests, similarly only has a sensitivity of 17.2% for small polyps.
(Imperiale, NEJM, 2014)

How does small polyp progress to colorectal cancer?

Illustration adapted from Metagenomic and Metabolomic Analyses Reveal Distinct Stage-specific Phenotypes of the Gut Microbiota in Colorectal Cancer,
by Yachida et al., Nature Medicine, 2019 and Sporadic (Nonhereditary) Colorectal Cancer: Introduction, by Johns Hopkins Colon Cancer Center. https://www.hopkinsmedicine.org/gastroenterology_hepatology/_pdfs/small_large_intestine/sporadic_nonhereditary_colorectal_cancer.pdf

*Small polyp refers to non-advanced adenoma, large polyp refers to advanced-adenoma

Removed adenoma has a 50% chance of recurrance^#1

#1. ME Martinez, R Sampliner, JR Marshall, et al. Adenoma characteristics as risk factors for recurrence of advanced adenomas. Gastroenterology 2001;120:1077-83.

Early detection and removal of precancerous polyps (adenomas) can prevent CRC and reduce mortality²

The microbiome is closely related to CRC. Intestines that are persistently exposed to a hostile microbial environment have higher risks for CRC. Scientists from the Faculty of Medicine of A Renowned University in Hong Kong are among the first in the world to identify a series of bad bacteria that are specific to CRC populations. By measuring the levels of these bacteria, we detect CRC and colorectal polyps, including small polyps, and recurrent adenoma, at extremely high sensitivity. Through this measurement, we can also compute your gut microbial health, informing dietary adjustments and microbiota modulation to reduce the risk for having CRC.

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Gut Microbiome is Linked to the Development of Colorectal Cancer

We cannot edit our human genome, but we can modulate our gut microbiome to improve health

The gut microbiome dictates human health. In fact, 90% of cell counts in a human body belong to microbes, most of which reside in the intestine and interact with human cells. Studies found that:

Only 12-35% of CRC can be explained by hereditary factor4

The gut microbiome of CRC patients is different from that of healthy individuals7

Gut microbiome dysbiosis may promote cancer formation in the colon5

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The Features of G-NiiB M3CRC
WORLD’S FIRST NON-INVASIVE Colorectal Cancer Risk Prediction Test that detects non-advanced adenoma

Detects colorectal cancer, non-advanced adenoma and recurrent adenoma through testing bacteria from stool

Non-invasive and painless stool collection

94% sensitivity for CRC is as robust as colonoscopy 10

Sensitivity for adenoma is superior to currently available non-invasive tests

Dietary recommendations included

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How does G-NiiB M3CRC predict the risk of colorectal cancer, adenoma and adenoma recurrence?
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G-NiiB M3CRC measures the levels of M3 bad bacteria (patented discovery by the Faculty of Medicine of A Renowned University in Hong Kong) plus hemoglobin in the stool. Using our propriety algorithm, we generate 3 risk indices corresponding to risks of colorectal cancer, adenoma and adenoma recurrence. Higher risk indices reflect higher risks of having colorectal cancer, adenoma and adenoma recurrence.

Colorectal Adenoma Risk Index

Colorectal Cancer Risk Index

Colorectal Cancer Adenoma Recurrence Risk Index

The Test Journey

‍The Advantages of G-NiiB M3CRC

G-NiiB M3CRC is the World’s FIRST NON-INVASIVE Colorectal Cancer Risk Prediction Test that detects non-advanced adenoma and adenoma recurrence with High Sensitivity. The sensitivity of CRC detection is 94%, which is comparable to colonoscopy10 and the specificity is 85%. The sensitivity of adenoma detection is superior to the currently available non-invasive tests (especially for small polyps)10

M3CRC

# Sensitivity detection

CRC

94%

56.8%

nAA

44.2%

Adenoma Recurrence

Can up to 90%¹²

*at 85% specificity
CRC: colorectal cancer
‍AA: advanced adenoma
‍nAA: non-advanced adenoma

Applicable Users

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A novel tool for monitoring gut microbial health

A persistently high score indicates a hostile microbial environment that is favorable for the development of CRC.

Flexible stool collection at home

Please follow this video guide to collect the stool sample.

To ensure the accuracy of the testing, please read the following notes carefully：

Maintain regular diet within 2 weeks；
Avoid antibiotics within 4 weeks；
Avoid probiotics within 4 weeks；
Do not collect the stool sample when it is watery due to diarrhoea and when there is bleeding from haemorrhoids and menstruation；
Follow this Guide to collect the sample carefully. Return the sample within 24 hours.

FAQ

When Should I take the Test?

To predict the risk of having colorectal adenoma and colorectal cancer: ≥45 years old. The American Cancer Society (ACS) recommends that adults aged 45 years or above with an average risk of colorectal cancer undergo regular screening. 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. For stool-based tests, the ACS recommends regular screening every 1-3 years. For more information, please consult your doctor.
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For regular monitoring of gut microbial health: Any age G-NiiB M3CRC Non-Invasive Colorectal Cancer Risk Prediction Test can inform you of exposure to a hostile microbial environment that can promote colorectal cancer. Anyone can take the test to stay informed about his or her colorectal cancer-related gut microbial health. Please consult your doctor if you are interested in the test.

How does the microbiome relate to colorectal adenoma and colorectal cancer?

Experiments show that the gut microbiota is involved in colorectal cancer formation and progression. Clinically, patients with colorectal adenoma and colorectal cancer also have a characteristic “CRC microbiome” that is different from the microbiome of healthy people. Certain microbes within the microbiome can secrete toxins, damage DNA, and stimulate inflammation, contributing to adenoma and cancer

How can I improve my gut microbiome?

Lifestyle modifications can improve the human gut microbiome. Evidence suggests dietary intervention, weight reduction, and the administration of probiotics, prebiotics, or synbiotics can modulate the gut microbiome. The G-NiiB M3CRC Non-Invasive Colorectal Cancer Risk Prediction Test contains a dietary recommendation that is tailored to test results.

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What is the scientific evidence behind the test?

The test is based on a clinical study involving over 1,000 colorectal adenoma, colorectal cancer, and control subjects. The test score is significantly elevated in patients with colorectal adenoma and colorectal cancer patients compared with control subjects (p<0.0001)

Why should I choose G-NiiB M3CRC Non-Invasive Colorectal Cancer Risk Prediction Test over other non-invasive CRC screening test?

G-NiiB M3CRC Non-Invasive Colorectal Cancer Risk Prediction Test is more sensitive than other commercially available tests on detecting colorectal cancer and colorectal adenomas, including non-advanced adenomas, which are often referred as small polyps. At 85% specificity, G-NiiB M3CRC has a sensitivity of 94% in colorectal cancer detection, which is comparable to colonoscopy. The sensitivity of non-advanced adenoma (/small polyps) detection, is 5 times more superior than FIT, a widely used risk prediction test (merely 7.6% sensitivity).

Does the G-NiiB M3CRC Non-Invasive Colorectal Cancer Risk Prediction Test complement with endoscopy?

Yes. G-NiiB M3CRC Non-Invasive Colorectal Cancer Risk Prediction Test can serve as a non-invasive and early step to identify patients who are at higher risk of colorectal adenoma and colorectal cancer, who are otherwise reluctant to perform endoscopy.

How often should I prescribe M3CRC risk prediction test to my patients?

Based on re-screening practices in Hong Kong and advice of US Centres for Disease Control and Prevention, G-NiiB recommends a follow-up test every year.

Can I take the test if I have been on antibiotics?

We recommend a wait of at least one month after any short-term antibiotic use before testing.

Again, this is because it is best to sample at a time that reflects your “normal” gut microbiome.

Can I take the test when I am sick or suffer from long-term health conditions?

Yes, anyone can take our test. Our method of examining your gut bacteria is non-invasive and the initial test can be completed at your home. If you have a medical condition, please consult with a medical professional before making any changes to your diet or lifestyle.

Will medicines interfere with my results?

Yes. Some medications can change your gut microbiome. However, it is not necessary to stop with long-term medications before taking the test, if these medications are part of your normal diet.

If in doubt, consult our customer support.

References

C Allemani, T Matsuda, V Di Carlo, R Harewood, M Matz, M Niksic, A Bonaventure, M Valkov, CJ Johnson, J Esteve, OJ Ogunbiyi, ESG Azevedo, WQ Chen, S Eser, G Engholm, CA Stiller, A Monnereau, RR Woods, O Visser, GH Lim, J Aitken, HK Weir, MP Coleman, and CW Group, Global surveillance of trends in cancer survival 2000 14 (CONCORD 3): analysis of individual records for 37 513 025 patients diagnosed with one of 18 cancers from 322 population based registries in 71 countries. Lancet, 2018 .39 110125 ): p. 1023 1075
JJ Sung, SC Ng, FK Chan, HM Chiu, HS Kim, T Matsuda, SS Ng, JY Lau, S Zheng, S Adler, N Reddy, KG Yeoh, KK Tsoi, JY Ching, EJ Kuipers, L Rabeneck, GP Young, RJ Steele, D Lieberman, KL Goh, and G Asia Pacific Working, An updated Asia Pacific Consensus Recommendations on colorectal cancer screening. Gut, 2015. 64(1): p. 121-32.
Statistics adapted from the American Cancer Society's (ACS) publication, Cancer Facts & Figures 2020 and the ACS website (January 2020).
SH Wong and J Yu, Gut microbiota in colorectal cancer: mechanisms of action and clinical applications. Nat Rev Gastroenterol Hepatol, 2019. 16(11): p. 690-704.
SH Wong, L Zhao, X Zhang, G Nakatsu, J Han, W Xu, X Xiao, TNY Kwong, H Tsoi, WKK Wu, B Zeng, FKL Chan, JJY Sung, H Wei, and J Yu, Gavage of Fecal Samples From Patients With Colorectal Cancer Promotes Intestinal Carcinogenesis in Germ-Free and Conventional Mice. Gastroenterology, 2017. 153(6): p. 1621-1633 e6.
G Nakatsu, X Li, H Zhou, J Sheng, SH Wong, WK Wu, SC Ng, H Tsoi, Y Dong, N Zhang, Y He, Q Kang, L Cao, K Wang, J Zhang, Q Liang, J Yu, and JJ Sung, Gut mucosal microbiome across stages of colorectal carcinogenesis. Nat Commun, 2015. 6: p.8727.
Z Dai, OO Coker, G Nakatsu, WKK Wu, L Zhao, Z Chen, FKL Chan, K Kristiansen, JJY Sung, SH Wong, and J Yu, Multi-cohort analysis of colorectal cancer metagenome identified altered bacteria across populations and universal bacterial markers. Microbiome, 2018. 6(1): p. 70.
J Yu, Q Feng, SH Wong, D Zhang, QY Liang, Y Qin, L Tang, H Zhao, J Stenvang, Y Li, X Wang, X Xu, N Chen, WK Wu, J Al-Aama, HJ Nielsen, P Kiilerich, BA Jensen, TO Yau, Z Lan, H Jia, J Li, L Xiao, TY Lam, SC Ng, AS Cheng, VW Wong, FK Chan, X Xu, H Yang, L Madsen, C Datz, H Tilg, J Wang, N Brunner, K Kristiansen, M Arumugam, JJ Sung, andJ Wang, Metagenomic analysis of faecal microbiome as a tool towards targeted noninvasive biomarkers for colorectal cancer. Gut, 2017. 66(1): p. 70-78.
Q Liang, J Chiu, Y Chen, Y Huang, A Higashimori, J Fang, H Brim, H Ashktorab, SC Ng, SSM Ng, S Zheng, FKL Chan, JJY Sung, and J Yu, Fecal Bacteria Act as Novel Biomarkers for Noninvasive Diagnosis of Colorectal Cancer. Clin Cancer Res, 2017. 23(8):p. 2061-2070.
Liang JQ, Li T, Nakatsu G, et al. A novel faecal Lachnoclostridium marker for the non-invasive diagnosis of colorectal adenoma and cancer. Gut. 2020;69(7):1248-1257.
Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014 Apr 3;370(14):1287-97.
Liang JQ, Zeng Y, Kwok G, et al. Novel microbiome signatures for non-invasive diagnosis of adenoma recurrence after colonoscopic polypectomy. Aliment Pharmacol Ther. 2022;55(7):847-855.

Disclaimer

M3CRC™ (“Test”) is not a diagnostic test. The test result of the Test should be interpreted with caution. A test result of "low" to "medium" risk of having colorectal adenoma and "low" risk of having colorectal cancer does not guarantee the absence of colorectal adenoma and/or colorectal cancer. A test result of "medium-high" or higher risk of having colorectal adenoma and "medium" or higher risk of having colorectal cancer does not guarantee the presence of colorectal adenoma and/or colorectal cancer. A test result of “low” risk of recurrence does not guarantee the absence of recurrence. A test result of “high” risk of recurrence does not guarantee the presence of recurrence. The screening interval for the Test has not been established. This leaflet is not intended to serve as a substitute for professional medical help or advice. If you have any questions regarding the above information, always seek advice from your doctor.

This product is not registered under the Pharmacy and Poisons Ordinance or the Chinese Medicine Ordinance. Any claim made for it has not been subject to evaluation for such registration. This product is not intended to diagnose, treat or prevent any disease.
此產品沒有根據《藥劑業及毒藥條例》或《中醫藥條例》註冊。為此產品作出的任何聲稱亦沒有為進行該等註冊而接受評核。此產品並不供作診斷、治療或預防任何疾病之用。