SBIR Phase I:Automated Processes for Rapid Analyzation of Biopsy Samples

The broader impact of this Small Business Innovation Research (SBIR) Phase I project is to provide an efficient, automated biopsy diagnostic process which will allow patients to access high quality cancer diagnostics at lower cost and without being subjected to unnecessary and painful repeat procedures from inefficient biopsy processes. The innovation addresses a critical global need to improve the efficiency and analytics of biopsies. An automated, rapid on-site evaluation (ROSE) system will potentially eliminate the 20% fail-rate of fine needle aspiration (FNA) biopsy sampling. The application may also be scaled to provide a solution to facilities that may not be able to afford the rapid onsite evaluation service of FNA.The proposed project aims to provide an automated, rapid on-site evaluation process by leveraging a system-engaging technology and robotics to increase fine needle aspiration biopsy sampling efficiency and improve patient experience, while reducing costs to ensure accessibility to all facilities. This device will have three processes to produce an image-ready glass slide that a pathologist can access remotely and render an adequacy assessment. The device will perform smearing, staining, and image capture of a fine needle aspiration biopsy sample. Normally, these processes are performed by a pathologist/cytotechnologist, making rapid on-site evaluation service inaccessible to fine needle aspiration providers in most rural or small facilities. With an automated device, the rapid on-site evaluation service may be mroe readily available and accessible at a fraction of cost, saving time and resources for patients and medical providers.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.