Helitope® - for gastric cancer risk

The First Peptide Blood Test to Identify High-Risk H. pylori Infections

We identify which H. pylori infections carry cancer-causing CagA proteins.

Our proprietary diagnostic detects antibodies to CagA proteins, distinguishing oncogenic from benign H. pylori strains. Outside East Asia, approximately 50% of H. pylori strains produce CagA – but current tests can't tell the difference. This precision assay enables targeted intervention where its needed most.

Asymptomatic H. pylori is common worldwide—quiet, persistent, including high-risk, cancer-linked strains. Symptomatic cases tend to get treated; the silent carriers don’t, allowing ongoing gastric damage. When gastric cancer finally declares itself, it’s often late-stage and with high mortality.

The Precision Medicine Opportunity

Current Screening Fails Patients and Healthcare Systems

Half the world's population carries H. pylori, but it is the CagA variants that drive gastric cancer. Current tests can't distinguish CagA-positive from CagA-negative infections.

The result: Either we treat all H. pylori blindly, including those with minimal cancer risk, or we miss the high-risk infections that cause over 700,000 annual gastric cancer deaths.

Helitope changes this equation. By identifying CagA-positive infections specifically, healthcare systems can:

Target the infections that actually increase cancer risk
Reduce unnecessary treatment of low-risk infections
Save treatment costs through precision intervention
Reduce global antibiotic burden and AMR risk
Transform gastric cancer from the third deadliest cancer to a preventable disease

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How Helitope® Works

Epitope-Level Precision Beats Whole-Protein Approaches

Standard H. pylori tests detect infection presence. Helitope detects cancer risk.

Our peptide-ELISA platform identifies antibodies specific to oncogenic CagA epitopes – protein regions that differentiate cancer-associated bacterial strains from benign ones.

We've validated these markers across:

1,200+ patient samples from multiple cohorts
>95% specificity for CagA variant identification
10-fold better signal-to-noise than conventional peptide assays

By combining the specificity of peptides with our patent-pending peptide augmentation, we have solved the historical sensitivity and specificity problems that have limited serology diagnostics.

Commercial Readiness

Development Complete

Epitope discovery and validation (2018-2021)
Clinical marker verification across diverse populations
Assay optimisation for commercial performance
Regulatory pathway defined for key markets

Manufacturing Established

Partnership with Biosensis Pty Ltd
Prototype production run completed June 2025
Scalable processes validated
First RUO kit production planned Q4, 2025

IP Protected

Core patent granted in 20 countries including US, China, Japan, EU
Peptide augmentation technology (AU 2025902422) filed
Freedom to operate confirmed in major markets
Strategic patent portfolio continues expanding

Why Now?

Regulatory Momentum

WHO lists H. pylori as Group 1 carcinogen requiring intervention
Asian health ministries prioritising gastric cancer prevention
Precision medicine initiatives demanding better risk stratification

Healthcare Economics

Aging populations increasing cancer burden
Healthcare systems seeking prevention over treatment
Value-based care rewarding early intervention

Technical Readiness

Our peptide platform solves the serology accuracy barrier
Manufacturing costs enable population-wide screening
ELISA format ensures global laboratory compatibility

Questions?

Get in touch, we'd love to hear from you.