Salivary Liquid Biopsy as a Human-Relevant NAM for Regulatory and Biomedical Research

NSight contributes to consortia addressing HORIZON-HLTH-2026-01-TOOL-03 by providing a human-relevant, non-invasive New Approach Methodology (NAM) based on advanced salivary liquid biopsy.

The NSight technology enables ultra-sensitive detection of molecular biomarkers in saliva, offering a scalable and ethically sustainable alternative or complement to traditional animal-based and invasive testing methods. The approach is particularly suited to regulatory testing, safety assessment and translational biomedical research, in line with the objectives of the topic.

Key contributions include:

• Human-based NAM: non-invasive salivary liquid biopsy allowing repeated, longitudinal sampling directly in human subjects, increasing biological relevance and reducing reliance on animal models.

• High-sensitivity molecular endpoints: detection of proteins and other molecular signals with sensitivity several orders of magnitude higher than conventional assays, supporting early and predictive safety and efficacy assessment.

• Bridging experimental NAMs and regulatory decision-making: saliva-based biomarkers can be used to validate and contextualise data from in vitro, in silico and organ-on-chip models, strengthening translatability to humans.

• Data integration and standardisation: generation of FAIR, interoperable biomarker datasets suitable for validation, comparison and potential regulatory acceptance.

• Scalability and ethical sustainability: low-cost, stress-free sampling suitable for large cohorts and repeated measurements, aligned with the 3Rs principles and regulatory expectations for NAM adoption.

Within a consortium, NSight can act as technology provider and WP leader or co-leader for NAM development, biomarker validation and regulatory-relevant endpoint definition. By integrating salivary liquid biopsy into the NAM ecosystem, NSight strengthens the predictive power, human relevance and regulatory impact of next-generation biomedical research methodologies.