Automated Skin Punch Biopsy Tool

Abstract

The Syn-One skin punch biopsy test, developed by CND Life Sciences, provides pathological evidence for Parkinson’s disease, dementia with Lewy bodies, and related synucleinopathies. However, a 20-month review revealed high rates of unusable samples due to technique variability. The current multi-instrument workflow requires tweezers, a metal push rod, and a standard punch tool, contributing to reduced sample integrity due to pinching, pulling, and incorrect technique. We developed a single, integrated biopsy tool to streamline sample collection and transfer. The device combines a standard 3-mm skin punch with a spring-loaded syringe to generate controlled negative pressure for tissue retrieval. Sequential actuation via a side-click mechanism enables skin incision, sample extraction without repositioning, and direct expulsion into a collection tube, eliminating intermediate handling. Device performance was evaluated using orange analogs and ex vivo porcine tissue. No statistically significant difference in sample integrity was observed between the standard biopsy method and the integrated device (p = 0.05) after 5 procedure cycles. Further, our device achieved a sample integrity of 90.38% relative to the standard tool on porcine tissue. Designed with manufacturability in mind, the improved tool can be produced for under $10 and eliminates the need for tweezers and push rods. By reducing operator dependence and consolidating tools, this approach improves consistency, minimizes waste, and streamlines clinical workflow. BioCut offers a low-cost, scalable solution that enhances diagnostic reliability. With planned refinement, Class II FDA regulatory submission, and clinical validation in collaboration with CND, BioCut’s tool is positioned for integration into the Syn-One kit.

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