Fully automated cell-free DNA extraction and quantification - liquid biopsies safely from Patient to Lab

Introduction

Liquid biopsies are blood tests with growing potential in diagnostics for cancer and prenatal screening. Pre-analytical challenges, such as the need for a skilled workforce and strict logistic requirements for sample transportation, are limiting the full exploitation of the method. To address these technical issues, we developed a method for immediate and automated sample processing that provides a sample with higher reliability, less human labor, and fewer transport requirements.

BiopSense Innovation

BiopSense innovation is a fully automated disposable cartridge, where the blood is filtrated using a dedicated hollow fiber membrane and then cfDNA is isolated from the plasma in the microfluidic system. The resulting sample can then be transported by regular post and eluted at the destination to carry out the final analysis.

Control Unit

The cartridge is controlled by a control unit composed of:

• A vacuum generator
• Software
• A simple spectrophotometer

Project Objectives

In this EIC Transition project, our objectives are to:

1. Validate the automated cfDNA extraction technology.
2. Integrate all the features of the innovation in a single disposable cartridge, which will be ready for marketing, licensing, and IVD validation by the end of the project.

Collaboration with Customers

The cartridge design will be done in close collaboration with the potential customer sector (biotech companies and hospital laboratories) to use their feedback to develop:

• The user interface
• Manufacturability
• Regulatory compliance

The project will focus on the cartridge design and will outsource control unit development to a company with experience in vitro diagnostic devices designing and production.

Commercialization Strategy

In this project, the commercialization strategy for the next 5-10 years will be developed to define how our start-up company BiopSense will handle the disposable cartridge design and commercialization, as well as further R&D of the technology in additional applications.