TAS::75 0849::TAS SBIR TOPIC 257, PHASE II, EXERCISE OPTION YEAR 2

Fine Needle Aspiration Biopsy (FNAB) is 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 molecularly targeted agents (MTAs) against cancer will also demand the robust and reliable detection of novel molecular biomarkers in FNAB samples. One intriguing possibility is the identification of informative ex vivo biomarkers- dynamic biomarkers that can be elicited from live tumor cells obtained by FNAB. These ex vivo biomarkers have the potential to reveal the functional architecture of signaling pathways in individual tumors thus producing a molecular profile. We, and others, have successfully utilized FNAB samples for such studies using manual sample processing methods, but widespread application of this technique will require a robust and reproducible platform for implementation. In this contract proposal, we present an innovative FNA biopsy approach and instrument (SnapPath) that will uniquely address this unmet need. This proposal is extremely responsive to PHS 2009-1 (Topic 257), which expresses particular interest in "biopsy instruments and devices that preserve molecular profilesin tumors", including those that will "create an entirely new diagnostic area" and "enable individualized molecular therapy of solid tumors."