SBIR Phase I: Streamlining Liquid Biopsy Sample Preparation Through Automated Bisulfite Conversion

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is the development of an automated system that dramatically improves the preparation of blood-based cancer tests, known as liquid biopsies. Liquid biopsy has the potential to detect cancer earlier and for therapeutic monitoring and minimal residual disease testing by analyzing circulating tumor DNA shed by tumors into the bloodstream. However, the current preparation process is lengthy, expensive, and requires highly-skilled labor, limiting its widespread use. This project seeks to overcome these limitations by developing a miniaturized, cost-effective instrument that automates the most time-consuming and error-prone step in the workflow. By reducing labor costs, plastic waste, and sample handling errors, this innovation can make cancer screening faster, more cost-effective, and more accessible, especially for low- and mid-throughput clinics and labs. If successful, this technology will help bring non-invasive cancer testing to more patients, supporting faster diagnosis and therapeutic monitoring, better treatment decisions, and improved health outcomes, while reducing the economic burden of cancer care. This Small Business Innovation Research (SBIR) Phase I project aims to develop a microfluidic-based system that automates bisulfite conversion, a critical process in preparing tumor DNA for epigenetic analysis. Traditional methods require over 40 manual steps and expose DNA to harsh conditions for extended periods, resulting in significant sample loss and variability. This project will address these limitations by creating a disposable cartridge that enables efficient chemical processing of DNA in a small-volume format, coupled with a benchtop instrument that precisely controls fluid movement and processing. The research will focus on optimizing reaction conditions to maintain high DNA recovery and conversion efficiency while reducing processing time. The anticipated outcome is a functional prototype capable of producing high-quality results comparable to gold-standard manual protocols, but with minimal human intervention. This technical advance will remove a major bottleneck in cancer diagnostics and lay the groundwork for fully automated sample preparation systems in molecular testing. 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.