Rhythm Biosciences (ASX: RHY) has launched an enhanced version of its geneType CRC risk assessment test, integrating genetic, clinical and lifestyle risk factors to improve colorectal cancer risk stratification. The updated test incorporates gender-specific variables and a 140-SNP polygenic risk score, delivering stronger predictive accuracy for both men and women across a wider age range, with validation data recently published in the peer-reviewed journal PLOS ONE.
The commercial release strengthens (ASX: RHY)’s position in preventative cancer diagnostics by creating a complementary pathway to its ColoSTAT® blood-based detection test. With Australian bowel cancer screening compliance below 50%, the enhanced test targets a significant gap in early identification of at-risk individuals, particularly addressing the growing incidence of early-onset colorectal cancer in younger adults.
Rhythm Biosciences geneType CRC Launch Delivers Enhanced Risk Prediction
The updated geneType CRC test represents a material advancement in personalised cancer risk assessment by combining a 140-SNP polygenic risk score with additional clinical and lifestyle risk factors. This integration addresses limitations in traditional risk models, which typically rely on family history and age alone, by incorporating modifiable factors that contribute to disease development.
Validation data published in PLOS ONE confirms the enhanced model’s improved predictive performance compared to conventional approaches. The test is designed to identify individuals at elevated colorectal cancer risk earlier in the disease trajectory, enabling more targeted screening interventions before symptoms emerge.
“The enhanced geneType CRC test strengthens our ability to identify individuals at elevated risk earlier, supporting more targeted screening and complementing ColoSTAT’s® role in colorectal cancer detection,” said Dr Erika Spaeth, Director of Clinical Affairs at Rhythm.
Key clinical applications include:
- Improved risk stratification across both genders, with particular benefits for identifying higher-risk women
- Identification of younger adults at risk of early-onset colorectal cancer, supporting earlier screening interventions
- Potential to encourage greater participation in bowel cancer screening programmes by providing personalised risk insights
The commercial availability of the test creates an immediate revenue-generating capability for Rhythm Biosciences, expanding its diagnostic portfolio beyond ColoSTAT®. Evidence suggests approximately 50% of colorectal cancer cases could be prevented through healthy lifestyle modifications, positioning the test at the intersection of precision medicine and preventative health strategies.
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How Does geneType CRC Risk Test Work with ColoSTAT®?
The enhanced geneType CRC test creates a complementary diagnostic pathway with Rhythm’s ColoSTAT® blood-based detection technology. The risk assessment identifies individuals with elevated genetic and lifestyle-based susceptibility, who then become candidates for closer clinical monitoring through colonoscopy, faecal immunochemical testing (FIT), or ColoSTAT® screening.
This two-stage approach addresses different points in the cancer detection continuum. geneType CRC performs risk stratification before disease onset, while ColoSTAT® detects existing colorectal cancer through five specific protein biomarkers in blood samples. The integration potentially expands the addressable market for both technologies by identifying previously unscreened at-risk populations.
A polygenic risk score combines genetic variations across multiple gene locations to estimate disease susceptibility. The geneType CRC test analyses 140 specific genetic markers (single nucleotide polymorphisms or SNPs) associated with colorectal cancer risk, integrating this genetic data with clinical and lifestyle factors to produce a comprehensive risk profile.
Individuals classified as higher risk through geneType CRC testing may benefit from earlier or more frequent screening than standard population-based recommendations. In Australia, where compliance with recommended bowel cancer screening programmes remains below 50%, personalised risk insights could drive greater participation by demonstrating individual relevance rather than generic age-based guidelines.
The referral pathway creates potential demand synergies between the two products. As geneType CRC identifies high-risk cohorts, a proportion may elect ColoSTAT® testing as a less invasive monitoring option compared to colonoscopy, particularly for individuals without symptoms who require regular surveillance.
What Are the Benefits of Enhanced Colorectal Cancer Risk Testing?
The updated geneType CRC test addresses three material gaps in current colorectal cancer risk assessment: gender-specific prediction accuracy, early-onset disease detection, and lifestyle factor integration.
Gender-specific variables deliver stronger predictive accuracy for women, a historically underserved segment in cancer diagnostics. Research indicates significant disparities exist in colorectal cancer screening, diagnosis and treatment between men and women, with detection rates and survival outcomes varying by gender. The enhanced model’s improved female risk stratification aligns with growing recognition of women’s health gaps in medical diagnostics, quantified by McKinsey Health as a $1 trillion global opportunity.
The test’s expanded age range capability addresses rising early-onset colorectal cancer incidence in adults under 50, a demographic typically excluded from population-based screening programmes. Early identification of younger high-risk individuals supports intervention before disease progression, when treatment outcomes are most favourable.
| Factor Type | Traditional Risk Models | Enhanced geneType CRC |
|---|---|---|
| Genetic Data | Family history only | 140-SNP polygenic risk score |
| Clinical Variables | Age, limited demographics | Gender-specific clinical factors |
| Lifestyle Integration | Not typically included | Modifiable risk factors incorporated |
Lifestyle factor integration creates actionable risk reduction pathways. Evidence suggests approximately 50% of colorectal cancer cases could be prevented through modifications to diet, physical activity, alcohol consumption and smoking behaviour. By quantifying lifestyle-attributable risk alongside genetic predisposition, the test enables personalised prevention strategies rather than generic public health messaging.
Clinical and lifestyle risk factors integrated into the enhanced test include:
- Body mass index and obesity indicators
- Dietary patterns and nutritional factors
- Physical activity levels
- Smoking status and duration
- Alcohol consumption patterns
- Personal history of polyps or inflammatory bowel disease
The combination of non-modifiable genetic risk with modifiable lifestyle factors provides a more complete risk profile than single-dimension assessments, supporting both clinical decision-making and patient engagement in prevention strategies.
Market Opportunity and Revenue Implications
The enhanced geneType CRC test addresses a substantial addressable market defined by suboptimal screening participation rates. In Australia, compliance with recommended bowel cancer screening programmes remains below 50%, indicating approximately half the eligible population either declines or does not access existing screening options.
This low participation rate represents both a market opportunity and a clinical challenge. Personalised risk assessment potentially increases engagement by replacing age-based population screening recommendations with individualised risk insights that demonstrate personal relevance. Individuals identified as elevated risk through geneType testing may be more motivated to pursue monitoring through ColoSTAT®, colonoscopy or FIT testing.
The test’s commercial availability creates an immediate revenue stream, distinguishing it from development-stage diagnostics requiring regulatory approval pathways. As a laboratory-developed test delivered through healthcare providers and genetic counsellors, geneType CRC can generate revenue while Rhythm continues ColoSTAT® commercialisation efforts in parallel.
Near-term commercial opportunities include:
- Integration into general practitioner and specialist gastroenterology practices for risk stratification
- Deployment in family history clinics serving individuals with hereditary cancer concerns
- Corporate wellness programmes seeking preventative health screening options
- Private pathology networks offering comprehensive cancer risk assessment panels
Distribution through healthcare providers and genetic counsellors ensures appropriate clinical oversight whilst creating multiple channel pathways. The test’s multi-disease assessment capabilities (covering breast cancer, cardiovascular disease, diabetes, prostate cancer and melanoma beyond colorectal cancer) provide cross-selling opportunities within existing distribution relationships.
The dual product strategy positions Rhythm Biosciences across both risk prediction and disease detection segments, creating a competitive differentiation versus single-product diagnostics companies. As geneType CRC identifies high-risk populations, ColoSTAT® provides a blood-based monitoring solution for ongoing surveillance, potentially driving demand for both technologies within the same patient cohorts.
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Strategic Positioning and Future Growth Drivers
Peer-reviewed validation in PLOS ONE de-risks the enhanced geneType CRC test’s commercial deployment by providing independent verification of improved predictive performance. Publication in an established scientific journal signals methodological rigour and strengthens credibility with healthcare providers, payers and regulatory bodies who may assess the test’s clinical utility for reimbursement or guideline inclusion.
The geneType platform’s architecture supports multiple disease assessments beyond colorectal cancer, creating expansion pathways without requiring entirely new technology development. The platform currently enables risk assessment across breast cancer, cardiovascular disease, diabetes, prostate cancer and melanoma, with polygenic risk scores and clinical algorithms tailored to each condition.
This multi-disease capability positions Rhythm Biosciences within the precision medicine sector, where personalised risk assessment based on individual genetic and clinical profiles increasingly replaces population-based screening approaches. The global precision medicine market continues to expand as genomic sequencing costs decline and evidence accumulates supporting polygenic risk scores’ predictive value across multiple diseases.
The geneType platform’s multi-disease assessment capabilities include:
- Breast cancer risk prediction incorporating genetic and hormonal factors
- Cardiovascular disease assessment combining genetic susceptibility with metabolic indicators
- Type 2 diabetes risk evaluation integrating genetic markers and lifestyle factors
- Prostate cancer risk stratification for male patients
- Melanoma susceptibility assessment based on genetic and environmental factors
Intellectual Property Position
The ColoSTAT® technology is patent protected internationally, creating a defensive moat around Rhythm’s blood-based colorectal cancer detection capabilities. This IP coverage extends across multiple jurisdictions, protecting the five-biomarker panel and detection methodology from direct replication by competitors.
First-mover advantage in integrated genetic and lifestyle risk testing for colorectal cancer provides Rhythm Biosciences with market positioning ahead of potential competitors. Whilst polygenic risk scores exist for various diseases, the combination of genetic data with clinical and lifestyle factors in a commercially available test targeting the Australian market represents a differentiated offering.
The commercial launch timing aligns with growing healthcare system focus on preventative interventions and early detection strategies that reduce treatment costs and improve patient outcomes. As health systems globally face budget constraints and aging demographics, technologies that identify high-risk individuals for targeted screening potentially demonstrate health economic value by avoiding late-stage diagnosis and treatment costs.
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