Functional Signaling Profiles (FSP) reveal information regarding signal transduction networks, including pathway activation and feedback loops, that predict patient response to targeted drug therapy. Enabled by the SnapPath™ platform, FSPs are algorithm-based tests that compare stimulated/inhibited patient samples to unstimulated, basal samples. FSPs utilize phosphoprotein-based ex vivo biomarkers to yield functional information beyond what can be achieved with traditional static DNA/RNA biomarkers in dead tissue.

BioMarker Strategies' Pipeline
BioMarker Strategies is developing a pipeline of unique ex vivo biomarker tests to inform targeted drug treatment selection, including combination therapies, for cancer patients with melanoma, breast, colon, lung, pancreatic and other solid tumors. As demonstrated below, our technology is uniquely suited to assess the functional bypass mechanisms of BRAF inhibition in melanoma and facilitate novel therapeutic strategies for BRAF inhibitor resistance.

Ex vivo Biomarkers
Ex vivo biomarkers are dynamic molecular markers, such as phosphoproteins, that are evoked from live tumor cells after being removed from a patient. Unlike static biomarkers detected from FFPE-based tumor samples, ex vivo biomarkers enable true functional tests of cancer cells and reveal important elements of tumor cell biology, including signal transduction circuitry.  SnapPath™ is an enabling platform for this new class of biomarkers, including ex vivo-based companion diagnostics.  

Much of the early work in ex vivo biomarkers was pioneered in leukemia and lymphoma.  BioMarker Strategies has extended this work to solid tumors using the SnapPath™ live tumor testing platform. In addition to the publication of Dr. Clark’s scientific review of ex vivo biomarkers in 2009, the company’s scientific work has been accepted as abstract presentations at the 2011 International Melanoma Congress meeting (Abstract | Poster), 2011 AACR meeting (Abstract | Poster), and 2010 San Antonio Breast Cancer Symposium (Abstract | Poster).

Enabling Traditional and Ex vivo BioMarker Analysis
The five vials of processed tumor sample, pictured below, represent the output of the SnapPath™ system that will be shipped to BioMarker Strategies' centralized lab for off-platform analysis. One of the vials contains unstimulated tissue that is is optimally-prepared for traditional DNA/RNA analysis. Thus, SnapPath™ enables a comprehensive molecular analysis of the tumor, both with traditional and ex vivo biomarkers.