Microbiome-derived metabolites for early detection of anal precancer

Sergio Serrano-Villar.

Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal, Spain.

Anal precancer is largely preventable, but people living with HIV face a much higher risk than the general population. Current screening using anal cytology has limited specificity and often leads to unnecessary referrals for high-resolution anoscopy, an invasive and resource-intensive procedure. MEDAL aims to develop a minimally invasive, accurate, cost-effective diagnostic tool based on microbiome-derived biomarkers.

The MEDAL KIT will translate validated biomarkers into a scalable assay for routine clinical laboratories. The assay will measure two metabolites that are markedly increased in people with anal precancerous lesions and is designed to fit existing laboratory workflows without requiring specialised equipment. The current development programme includes analytical validation, prospective multicentre clinical evaluation and preparation for European regulatory approval.

If successful, the test could reduce unnecessary anoscopies, improve screening efficiency and lower healthcare costs. Because these metabolites may serve as specific biomarkers across multiple epithelial cancers, the same platform is also being explored for cervical and colorectal precancer.

STAGE 3