Theragnostics

Several features distinguish theragnostics from other approaches. First, it provides actionable therapeutic guidance for a single patient, as well as for stratified subsets or for an entire disease-specific population. Secondly, depending on a disease indication and the stage of the disease, it attempts to achieve excellent treatment responses such as cure, disease remission, or excellent response. Third, it guides efficacy and financial assurances.

Theragnostics involve any combination of tests involving biomarkers, diagnostic tests, and immune markers, etc., to provide treatment decision criteria with an objective of achieving remission or excellent response:

Therapeutic appropriateness: selection of a therapeutic (drug) when multiple therapeutics are available in a formulary to choose from, for an entire disease population (e.g., RA), a particular subset(s) of patients, or an individual patient

Therapeutic guidance: provides details of therapy regimen, including specific drug dosing and schedule details during a treatment cycle

Therapeutic evaluation: measure of how well a patient responded to that treatment--during and at the end of the treatment cycle

Selection of an alternative therapeutic: a mechanistic rationale to select the next best choice from the drug formulary, if the first drug failed to achieve the desired therapeutic effectiveness

Theragnostic methods are primarily mechanism-based: MOA of a drug, disease severity subtypes, etc. The Company employs both stratified medicine and personalized medicine approaches in its precision medicine paradigm.