I-Corps: An efficient automated biopsy diagnostic process

The broader impact/commercial potential of this I-Corps project will explore the market need for an efficient automated biopsy diagnostic process. Annually, 2.5 million Fine Needle Aspiration (FNA) biopsies are performed in the US. Twenty percent of these FNAs will prove to be inadequate for diagnosis or downstream molecular testing.

This failure results in patients being re-admitted for repeat FNA biopsies and, as a consequence, insurers, hospital, physicians and patients lose time and money, and patients have added anxiety as they wait for medical results. This failure amounts to over $3 billion in annual losses from all parties. The proposed technology would improve patient access to high quality cancer diagnostics and reduce unnecessary repeat procedures due to inefficiencies in the biopsy processes.

This I-Corps project aims to validate the need for an automated biopsy process. The Rapid On-Site Evaluation (ROSE) technology checks the adequacy of a specimen as part of a Fine Needle Aspiration (FNA) biopsy. Although FNA is usually image-guided (e.g. through a computerized tomography (CT) scan or ultrasound guidance), the procedure itself is still regarded as a (semi-) blind procedure.

It is not unusual to have inadequate (sometimes acellular) specimens that lack a sufficient amount of appropriate material, leading to diagnostic or therapy guidance failure, increased cost and unnecessary physical and emotional consequences for the patient. The proposed ROSE technology may vastly increase sampling efficiency and improve the patient experience, while reducing costs.

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.