Biotome Achieves Manufacturing Milestone in Gastric Cancer Prevention

Biotome is pleased to announce the arrival of our first prototype diagnostic test kits from manufacturing partner Biosensis Pty Ltd. These kits represent the culmination of years of research into precision detection of high-virulence Helicobacter pylori strains that significantly elevate gastric cancer risk.

Addressing a Global Health Challenge

While H. pylori affects approximately half the global population, specific strains with CagA proteins pose significantly greater cancer risk. Current non-invasive diagnostics cannot distinguish between benign and oncogenic strains – a critical gap in preventive healthcare that our technology addresses.

Our diagnostic platform identifies antibodies specific to high-risk CagA epitopes, enabling clinicians to stratify patients who require intensive surveillance or intervention. This precision approach transforms gastric cancer from a disease we treat to one we can prevent.

From Discovery to Manufacturing

The path to this milestone reflects the rigorous demands of diagnostic development:

Epitope Discovery and Validation

Our team analyzed thousands of CagA sequences using high-density peptide microarrays (PEPperPRINT GmbH), identifying epitopes unique to cancer-associated strains. This discovery phase alone involved screening over 1,000 96-well microplates – a testament to the thoroughness required in biomarker validation.

Antibody Development

We established and screened hundreds of hybridoma cell lines to develop monoclonal antibodies with the specificity and affinity required for clinical diagnostics.

Platform Innovation

A key technical achievement was our patent-pending peptide-ELISA platform, which overcomes the signal-to-noise challenges that have historically limited peptide-based diagnostics. This innovation enables reliable detection at clinically relevant antibody concentrations.

Intellectual Property

Our peptide biomarkers are now protected by granted patents in over 20 countries, providing a strong foundation for global commercialisation.

Strategic Partnerships and Support

This achievement reflects the strength of Australia's biotechnology ecosystem. We acknowledge the critical contributions of:

• Biosensis Pty Ltd – Manufacturing expertise and quality systems

• MTP Connect and the Life Sciences WA – Strategic guidance and industry connections

• Western Australian Government – Through WA Health (FHRI Fund) and the Department of Jobs, Tourism, Science and Innovation

• Harry Perkins Institute of Medical Research – Housing our lab with supporting world-class research infrastructure

• The Marshall Centre at UWA – Clinical expertise and patient cohorts

Special recognition goes to our laboratory team: Paige Warburton, Paige Bebee, Soraya Leedham, and Liz Jaeschke-Angi, whose technical excellence and persistence have been instrumental in reaching this milestone.

Next Steps: Validation and Manufacture

With manufactured test kits now in hand, we enter the critical phase of kit validation. Our immediate objectives include:

• Confirming performance in reference samples

• Verification in diverse patient cohorts

• Comparison studies against current standard-of-care diagnostics

• Regulatory pathway planning for key markets

The transition from laboratory prototype to manufactured product is a significant inflection point for any diagnostic company. It validates not only the science but also the scalability and commercial viability of the technology.

Looking Forward

The arrival of these test kits marks a key stage in our progress from a research-focused organisation to a clinical diagnostics company. While we're quietly pleased to have navigated the considerable challenges of peptide chemistry, immunology, and manufacturing scale-up (with sanity mostly intact), we remain focused on the ultimate goal: delivering a diagnostic that can prevent millions of gastric cancer cases globally.

We look forward to sharing clinical validation results in the coming months as we work toward making gastric cancer prevention accessible worldwide.

For partnership inquiries or further information about our gastric cancer risk technology, please contact us at info@biotome.com.au.