A diagnostic test unit called PyroXpress with parts provided by Protomold, a rapid injection-moulding service offered by Proto Labs, based in Telford, Shropshire has been developed by Highland Biosciences in Inverness, Scotland.
The design comprises an eight-channel reader unit into which disposable plastic cartridges containing samples are slotted. The test starts automatically upon detection of the sample, with results appearing within 5 minutes. No special skills, tools or environmental conditions are required.
“One of the main challenges was developing the cartridge, a plastic component measuring around 40 x 25mm that comes in two parts – top and bottom – and also features a small handle,” says Emma Day, Technical Director at Highland Biosciences. Initially, Highland Biosciences experimented with rapid prototyping based on stereolithography (SLA) technology, but the results were far from satisfactory.
The speed and reliability of PyroXpress will eliminate the need to quarantine or scrap batches due to endotoxin non-compliance
“SLA didn’t work for us primarily because we couldn’t use the actual design material, and also because SLA models can shrink, go soggy and often offer poor presentation,” says Day. “We were facing up to either using the wrong material or paying for an expensive hard tool for injection moulding – until I saw the Protomold website that is, at which point I was ecstatic. Because the cartridge is disposable it was vital to achieve the correct design as we could potentially end up making millions.”
Using Proto Labs’ Protomold and FirstCut machining service, which allows customers to make a fully functional prototype early in the development cycle, Highland Biosciences was able to trial many materials with different design properties. From the performance data derived by this process, the company settled on a final design material, which remains a closely guarded secret.
In total, the project has generated four patents worldwide, with more in the pipeline.
Highland Biosciences says PyroXpress differs from alternative tests because it is based on specially developed multi-beam resonator technology that provides the sensitivity levels required for quick and accurate results.
“With the help of Protomold we have turned this test on its head,” says Day. “The speed and reliability of PyroXpress will eliminate the need to quarantine or scrap batches due to endotoxin non-compliance.”
PyroXpress is currently being scaled up to full manufacture and hard tools are in production. A starter pack will be available later this year offering an eight-channel reader; 500 ready to use disposable cartridges; and a 12-month support package including two days of method development and validation.
