Navigate BioPharma Services, an independent subsidiary of Novartis, has introduced a new assay for quantifying pharmacodynamic markers of radioligand therapies in tumours.

The new multiplexed fluorescence immunohistochemistry (mFIHC) assay is designed to measure the changes in the cancer cells and the tissue after radioligand therapy (RLT).

It uses multiplex immunofluorescence (mIF) plus automated quantitative analysis (AQUA) algorithms to accurately measure changes in key protein markers after RLT.

According to the company, the ionising radiation produced by radioisotopes causes double-stranded breaks either directly or through the generation of reactive oxygen species.

The DNA is damaged due to an increase in markers for cell cycle arrest and DNA repair proteins, making the proliferating cells most susceptible to ionising radiation.

The new assay incorporates the biologically verified markers to measure the pharmacodynamic activity of RLTs and gain insights into DNA damage response and mechanism.

The approach offers a complete exploration of a radioligand therapy’s impact on the cell cycle and DNA damage within a tumour and tumour microenvironment, said Navigate BioPharma.

Navigate BioPharma Services Digital Pathology Associate Director Jennifer Bordeaux said: “Radioligand therapies hold immense promise for targeted cancer treatment.

“Our new assay provides drug developers with a powerful tool to assess the therapeutic effects of these agents, ultimately accelerating drug development and improving patient outcomes.”

Navigate BioPharma Services said that its new assay provides several advantages including multiplex analysis, AQUA algorithms, and enhanced sensitivity.

The image-based test enables simultaneous evaluation of multiple protein markers, providing a more holistic view of RLT’s mechanisms of action.

It ensures objective quantification of changes in biomarkers, reducing variability and improving data quality.

Also, the assay detects even small changes in protein levels, to provide a more accurate assessment of therapeutic efficacy.

Navigate BioPharma Services is a speciality laboratory that offers high-quality precision medicine solutions and bioanalytics for clinical development and diagnostic applications.