SnapPath (TM) Ex-Vivo Biomarker Platform @ BioMarker Strategies

"The next stage in the development of personalized medicine will require the integration of sample preparation and analysis in easy to use instruments"

Frost and Sullivan, Personalized Medication: 2006 Technology Trends Analysis

"There seems little doubt that biomarkers will be one of the major drivers of pharmaceutical research and development in the 21st Century."

Thomson - Reuters, "Establishing the Standards for Biomarker Research." 2009

Fine needle aspiration biopsies (FNABs) are a minimally-invasive method for sampling human tumors that is widely used in the United States. Historically FNAB samples have provided adequate material for microscopic examination, however the successful development and use of targeted cancer drugs will also require biomarker information derived from these clinical samples.

While ex vivo biomarkers have been used successfully in various clinical trials using manual live tissue manipulation at the patient’s bedside. Ex vivo tests are not clinically feasible unless an automated, rapid processing device, such as SnapPath™ exists. The ability to interrogate live tumor cells with novel ex vivo biomarker tests to determine the most effective cancer treatment for individual patients is the promise of the SnapPath™ biomarker platform.

SnapPath™ benchtop units will utilize automated fluidic technologies to process and manipulate live tumor biopsy samples, within uniquely designed insertible cartridges. In the SnapPath™ system, radiologists will deposit (FNA) biopsy samples into a SnapPath™ cartridge immediately after the needle is removed from the patient. Cartridges will then be rapidly delivered to pathology where the SnapPath™ platform will be located, in a process similar to that required for lymphoma samples processed by flow cytometry.

Diagram

The SnapPath™ biomarker platform is being developed with a $2.3 million Fast-Track SBIR contract from the National Cancer Institute. In the NCI’s contract award, the agency stated that the company’s SnapPath™ technology presented an “innovative” FNA biopsy approach and instrument that was “extremely responsive” to the NCI’s contract announcement which expressed interest in “biopsy instruments and devices that preserve molecular profiles in tumors,” including those that will “create an entirely new diagnostic area” and “enable individualized molecular therapy of solid tumors based on accurate information about signal transduction pathways, molecular drug targets and biomarkers.” The NCI also recently stated that technologies focusing on ex vivo diagnostics and ex vivo tissue-analysis are a “priority” for the NCI’s SBIR Phase II Bridge Award program.