DISCOVERY & DEVELOPMENT

DIAGNOSTICS PLATFORM

GenieBiome found 4 Bacteria gene markers for diagnosis of colorectal cancer and adenoma...

DIAGNOSTICS PLATFORM

APPROACH

"Our proprietary microbial biomarkers are non-invasive, biologically relevant, and disease-specific..."
GenieBiome’s biomarker discovery platform utilizes in-depth metagenomic analysis of large human microbial datasets and in-house proprietary machine learning approaches to identify diagnostic microbiome signatures targeted to different human diseases. The gut microbiome is a rich source of biologically relevant biomarkers that can be transformed into precise diagnostic and prognostic tools. Clinicians can use them as non-invasive early diagnostic and monitoring tools to optimize clinical decision and improve patient care.
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DIAGNOSTICS PLATFORM

SOLUTION & PRODUCT

A stool microbiome precision test for early detection of colorectal adenoma and cancer.
GenieBiome (Diagnostic) has developed one of the world’s first microbiome-based diagnostic products to disrupt the diagnostic landscape of cancer diagnosis. Starting with one of the top killers globally, colorectal cancer, we have identified species-specific bacterial gene markers for early detection of colorectal cancer and adenomas. Our bacteria markers can detect colorectal cancer early, when it can be cured; and it can detect adenomas and prevent cancer development. 
  • 4 Bacteria gene markers for diagnosis of colorectal cancer and adenoma.
  • Detects CRC at 94% sensitivity, 85% specificity, for large and small adenomas.
  • FIRST LINE non-invasive microbiome precision screening test for early diagnosis of CRC and adenomas.
  • Superior to other non-invasive tests in detecting small and large precancerous lesions.
  • The first non-invasive marker that can predict adenoma recurrence with >90% sensitivity.
  • Accurate, Reliable, Affordable and Non-Invasive.
  • Tested and validated in over 1,200 cancer and polyp subjects.
  • Indicate individual gut microbial health.
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Using metagenomics analysis, we identified
20 gene markers that significantly differentiate CRC-associated and control microbiomes.
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Principal component analysis based on abundances of 20 gene markers separates CRC cases and control individuals significantly. 
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CRC index computed using a simple unweighted linear combination of log-abundance of 20 gene markers significantly distinguished patients with CRC (red) and control individuals (green), but not patients with type 2 diabetes or IBD and control individuals from other studies, suggesting that the 20 gene markers are CRC-specific. The box depicts the IQRs between the first and third quartiles, and the line inside denotes the median.
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M3CRC shows good diagnostic performance in discriminating patients with CRC and adenoma from control subjects according to receiver operating characteristic (ROC) curves analysis, with areas under ROC of 0.9763 and 0.7328 respectively.
Faecal Immunochemical Test (FIT) vs M3CRC
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M3CRC is superior to FIT for early cancer and adenoma detection.
How does the M3CRC work ?​
  • It is performed using an at-home kit that includes a container for a stool sample with a preservative. 
  • That sample is then shipped to the HK-based laboratory for testing.
  • The results will be available within 15 working days upon arrival at the laboratory.
  • Risk indices for adenoma & colorectal cancer
  • Dietary recommendations
  • Provides indicator of gut health.
  • High scores indicate a hostile microbial environment that favours colorectal tumorigenesis.
  • Low scores indicate a healthy microbial environment.
When and how often to take M3CRC test ?
  • Over 45 years old:
    •    Every 1-3 years according to screening guideline.
    •    High-risk subjects are recommended to take the test every year.
  • Repeat the test as a gut health indicator whenever appropriate.
M3CRC Report include:
 

DIAGNOSTICS PLATFORM

PIPELINE

"Our machine learning capability allows us to rapidly identify diagnostic microbiome signatures from enormous datasets of healthy and diseased individuals..."
GenieBiome Limited invests in scientific and technical excellence to develop and launch a diverse pipeline of novel products that target major unmet needs. Leveraging on our large human metagenomic datasets, we are developing a pipeline of microbiome diagnostics targeting gastrointestinal diseases and conditions that extend beyond the gut, with several candidates for autism spectrum disorder, eczema, obesity/metabolic diseases, and non-alcoholic fatty liver disease in pre-clinical development.  Clinical studies into the safety and efficacy of investigational products provide data to support applications to regulators for approval. 

Brand names are trademarks either owned by and/or licensed to GenieBiome Limited or associated companies.
GenieBiome’s biomarker discovery process uses in-house powerful analysis platform and leading bioinformatic approaches to achieve high accuracy and ensure minimal false negatives. Using our proprietary reference database consisting of > 10,000 sequenced datasets, we achieve unmatched coverage of the microbiome. We are developing a pipeline of microbiome diagnostics targeting gastrointestinal diseases and conditions that extend beyond the gut, with a panel of promising candidate markers in development for autism spectrum disorder, Crohn’s disease, irritable bowel syndrome, obesity and eczema.
Discovery Project
Pre-Clinical
Phase I
Phase II
Phase III
Registration
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Pipeline updated on Aug 3, 2021
# patented