For clinical investigators, Theranostics Health can provide translational research services that range from indication seeking studies through to Proof-of-Concept research efforts for Phase I and Phase II trials.
Our services can help identify, assess and validate target and pathway-specific biomarkers for signs of efficacy in early clinical trials to helping determine which disease indication, cancer population, or subset of patients would better respond to a therapy or combination of therapies.
An important consideration is that the RPMA platform’s sensitivity allows for a robust analysis of protein markers in the small biological samples that are commonly collected from human study participants. This analytical capability is applicable to frozen and formalin-fixed, paraffin-embedded (FFPE) samples.
- Indication seeking efforts to assess preclinical signature profiles against clinical samples to identify sensitive tumor types or clinical subtypes
Biomarker research capabilities for Phase I trials intended to measure signs of efficacy in study participants who may not belong to a candidate drug’s intended disease or cancer patient population. These capabilities include methods for direct or indirect measurement (through the use of surrogate marker systems) of drug activity, or inhibition – either through the direct measurement of the drug target itself, the activity of its downstream signaling pathway, and/or other classical markers of biological activity or function.
Surrogate Marker Systems
Customized analyses that our technologies can enable include:
- Direct measurement of biopsy materials from pre- and post-treatment time points
- Surrogate marker systems such hair follicles or skin punches
- Whole blood and separated immune cell populations, including ex vivo treated samples.
Build patient selection strategies based upon protein or phosphoprotein profiling of:
- Retrospective analysis of clinical study participants that seeks to correlate proteomic profies against response or non-response outcomes to treatment.
- Prospective analysis of potential study participants to identify markers that predict sensitivity prior to inclusion within a clinical trial.