SBIR Phase I: Microdissection Optimization for Molecular Profiling and Clinical Lab Use

Xmd Diagnostics, Inc., Annapolis MD

Investigators

Abstract

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project aims to improve cancer diagnosis and treatment. Cancer affects millions of Americans and people worldwide. The National Cancer Institute (NCI) reports that the number of new cancer cases will reach 30 million by 2040, representing an enormous cost to American society and the economy. There is a dire need for innovative technologies such as molecular diagnostics and personalized medicine to combat cancer. Modern molecular testing methods such as polymerase chain reaction (PCR) and next-generation sequencing (NGS) often suffer from low tumor content and genetic contamination from non-cancer cells contained in their samples - resulting in an insufficient amount of DNA for accurate molecular testing. This research will focus on microdissection as a means of obtaining cancer cells for testing. The proposed tumor cell purification and extraction will enable the company to focus on modelling and optimalization of individualized cancer treatments rather than non-cancer cells. The solution combines mathematical modeling, mathematical optimization, and real-world experimental verification which will contribute significantly to successful commercialization of clinical lab instruments and complementary products. This Small Business Innovation Research (SBIR) Phase I project aims to conduct scientific research to understand the optical, thermal, and mechanical interactions that occur during microdissection. The resulting modeling will be used to enable reliable extraction of cancer cells from patient biopsy samples, accounting for different sample types and cancer-cell stain intensities. Microdissection purifies cancer cells from human samples and enables molecular testing and genetic profiling. Current instruments for tumor cell purification and extraction are either arduous or unreliable. In this project, the aim is to conduct research to model and optimize the opto-thermal-mechanical interaction of microdissection by taking into consideration common tissue variations (i.e., tissue types, tissue thickness, and stain intensity). This technology will be used to determine the specific operating specifications for successfully micro-dissecting tissue specimens and developing an instrument for research and commercial clinical laboratory use. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.