Clinical Applications

Clinical R&D

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

  • Indication seeking efforts to assess preclinical signature profiles against clinical samples to identify sensitive tumor types or clinical subtypes

Proof-of-Concept

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.

Patient Stratification

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.