Tissue preservation tool for MDx

Spot On Sciences, Llc, Austin TX

Investigators

Abstract

? DESCRIPTION (provided by applicant): Innovative tools for solid, tissue biospecimen preservation are needed to meet the promise of molecular diagnostics (MDx) and personalized treatment for cancer diagnoses and disease research. Spot On Sciences will develop an efficient and cost-effective method for solid biospecimen preservation that can be performed in any location while improving sample stability and accessibility for molecular analyses. For this method, a small sample is collected from a freshly excised tissue and quickly homogenized in stabilizing buffer. The homogenate is applied to absorbent paper within an enclosed cartridge and rapidly dried by a desiccant. Once dried, analytes including nucleotides, proteins and small molecules show stability at room temperature for years. Leveraging a novel blood collection device previously developed by Spot On Sciences, HemaSpot, the enclosed cartridge prevents sample contamination and allows facile shipment to a testing laboratory at ambient temperature with no cold chain requirements. The device is pre- labeled by bar code for simplified sample tracking. Based on well-established dried blood spot technology, common analytical methods such as RT- PCR, immunochemistry and LC-MS/MS are highly compatible with these dried samples. The pre- cut paper on the HemaSpot device allows for easy removal of sample subsections for molecular analyses and research. Preliminary data in our lab suggests feasibility for tissue to be preserved as a dried homogenate on filter paper. This study will further explore these results and demonstrate capability for measuring a wide range of analytes including nucleotides, proteins and small molecules from the same sample. The ultimate goal for this project is to provide a commercial kit for point of care (POC) diagnostic facilities containing all needed reagents and a simple device for collecting and storing homogenized tissue samples. Minimal infrastructure requirements will allow sample collection from any environment including remote, rural and low resource areas while providing stable, quality samples under a wide range of ambient conditions. This innovative method would greatly simplify and reduce costs for biospecimen collection and storage while increasing availability for high quality samples for research and for molecular testing for prognostic and therapeutic benefit for cancer patients.