Our application of proven intelligence in preclinical pathology accelerates the development of advanced therapeutics and complex biologics. By generating objective, quantifiable data, we help sponsors minimize clinical risk on the path to regulatory submission.

From Subjective Observation to Objective Measurement

A standard, one-size-fits-all preclinical testing template does not exist for gene therapies. The biological activity of viral vectors like AAV or non-viral systems such as lipid nanoparticles (LNPs) requires a more precise approach to toxicologic pathology. Traditional semi-quantitative scoring, while established, introduces observer variability that can obscure subtle but meaningful findings.

Digital image analysis and whole-slide imaging remove this subjectivity. By converting entire tissue sections into high-resolution digital assets, we can deploy validated algorithms to measure pathological changes with mathematical precision. This approach generates objective data sets that are reproducible and directly comparable across cohorts and studies.

Quantifying Biodistribution and Transgene Expression

For gene therapy programs, understanding vector tropism and transgene expression is fundamental. Our pathology services use advanced techniques like multiplex in situ hybridization (ISH) with our digital analysis platform. This allows for the precise quantification of vector DNA, guide RNA, or messenger RNA within specific cell types and tissues.

This level of precision is needed when evaluating novel capsids or delivery systems. For instance, biodistribution studies assessing engineered AAV variants designed to modulate tissue targeting benefit from quantitative analysis that can detect subtle shifts in vector localization (PMID: 39001819). This objective data is invaluable for confirming on-target activity and identifying potential off-target liabilities early in development.