Functionomics: a post-genomic approach to molecular diagnostics focused on the ability to monitor and report on the expression of disease-specific protein targets for diagnosis, monitoring and drug selection.
The landscape of medical therapy is rapidly changing due to multiple factors, including:
- the reclassification of traditional disease types to molecularly distinct smaller subsets;
- a host of emerging and evolving drug targets, and a multiplicity of new targeted agents on the market and in clinical development;
- the inherent inability of the traditional large clinical trial mechanisms to cope with the above variables in a timely manner; and
- and the need for more individualized patient care.
As a result, there is a growing interest in a more flexible, biologically based and biomarker driven model of developing new targeted therapies and their clinical use. The effects of targeted agents are usually projected from indirect inferences (histology, statistics and empirically developed and usually disease-unspecific biomarkers). Whenever available, the analysis of molecular targets (e.g. HER2) is based on diseased tissue obtained at biopsy, or from surgical material. These approaches are associated with several technical and ethical limitations: difficulties with repeated and longitudinal collection of samples, invasiveness/risks of the sampling procedures, sampling errors due to tissue heterogeneity, inaccessibility of metastases or tissue not identified via imaging, uncertain roles of the markers in the malignant/disease process and inability to monitor whether the drug target is being hit by the therapeutic agent.
The findings of NX PharmaGen’s collaborators suggest that many of these barriers could be overcome by the analysis of circulating exosomes or microvesicles; in effect, a ‘liquid biopsy’ containing the fingerprint of the molecular circuitry of the originating tissue, including multimolecular patterns of responsiveness and resistance to therapeutics.
NX PharmaGen’s NeXosome TM Platform is designed to fulfill the promise of functionomics, utilizing a blood-based proteomic assessment of disease-specific exosomes or microvesicles for a variety of prenatal and oncology conditions.