Biotangents
/Point-of-Use detection of Mastitis in bovine milk samples
Biotangents came to Marble to assist in developing their lab based assay onto a complete system for point of use detection of specific Mastitis pathogens in cows to enable farmers and vet to target treatment with the appropriate antibiotics. The objective was to deliver pathogen specific results within a single milking cycle enabling farmers to isolate infected cattle and minimising disruption and cost. Marble lead three key workstreams including Sample Preparation, Cartridge Design and Diagnostic Device Development.
Defining the Problem and Writing the Specification
Although Biotangents assay performed perfectly in the lab, translating that to point-of-use device on the farm is a significant challenge. Marble spent time on the farm to understand the issues and conditions farmers, stockmen and vets face day-to-day - including the fact everything is literally covered in...
Cartridge & Device Concept Generation & Development
Marble generated multiple concepts for all element of the system before a rigorous process of evaluation and selection. A lead concept with fall back option was selected by the project team before proceeding with further development.
Sample Preparation
How do you enable farmers to deliver laboratory level precision and control to sample preparation without adding complexity and cost, especially when sample consistency varies from liquid milk, to cottage cheese. Marble proposed and developed a low-cost 'Kit of Parts' approach containing simple custom containers, filters and syringes enabling consistent, controlled, de-skilled sample preparation.
Cartridge Development
Biotangents needed a single-use diagnostic cartridge to accurately and repeatable detect up to six pathogens plus controls using Loop-mediated Isothermal Amplification (LAMP) techniques. Marble design the cartridge, selected the materials, and after considerable testing and evaluation commissioned toolmakers and moulders to product injection moulded parts. Simultaneously Marble worked with the supplier of Lyophilized beads containing the reagents for detection of specific pathogens and selected suitable top film to allow optical detection of the amplification signal generated by a positive detection.
Diagnostic Device Development
Marble successfully developed a complete working prototype of a LAMP based diagnostic device capable of detecting six pathogens using the eight well cartridge, from scratch, in 12 months. This included development of the optical detection system, cartridge heating control system and capture processing and display of results. The ‘works like model’ delivered comparable results to those achieved from the PCR testing.
Diagnostic Cartridge Tooling
Marble specified the design, selected materials and shortlisted the toolmaker to manufacture the Diagnostic Cartridge. This was a development cartridge to allow testing and verification of the design before committing to a final production design that would have all the necessary features to work with the Diagnostic Device.
Looks Like Works Like Device and Cartridge
To enable Biotangents to source additional funding and investment Marble also developed a Looks Like, Works Like p[rototype to showcase what a production device could look like and to demonstrate device UI.
