As a Social Enterprise we started with the big idea of how could we bring molecular diagnostics to more people in more settings around the world.

We had lots of very deep thinking sessions with health economists, path lab managers and friendly academics, picking their brains on how we could expand the test market.

The main block to testing is the cost. Realistically testing is only widely available in the richer nations and that’s because it costs so much to educate biomedical scientists, the equipment and the assays are really expensive, and the labs are expensive to set up in the first place and are often a very long way away from patients living in rural communities.

We spent months strategizing and eventually decided to develop a low-cost, high-throughput, easy to operate, mobile, molecular diagnostic platform based on the old gold standard methodology, qPCR.

We thought how difficult can it be, to combine our rapid qPCR thermal cycling technology with Festo’s automation into a mobile molecular diagnostics platform?

Simply combining standard liquid handling technology, mixing up an assay kit with patient samples, sealing them into a microtitre plate, running them through our qPCR cycler, and capturing the fluorescence readings, and finally sending the results off to a laboratory information system. Easy, right? (pause) Turns out, there was a bit more to it!

I’ve got to say, Festo have been amazing—a bit like a big brother, really. They made sure we really thought through the workflow and helped us create a User Requirement Specification or “URS.” Actually, we ended up with two URS’s—one for the hardware and one for the software.

We’ve been in PCR since 1991, so we thought we had a pretty good handle on qPCR. But automating means it’s no longer just human hands and brains in the mix. So, we had to really look at how labs manually handle patient samples, to make sure that it was right for them.

Along the way, we found ourselves in the middle, bridging the gap between automation engineers, software developers, consumables makers, and most importantly, the lab users of the platform.

Oh, and we also did a fundraise a third of the way in, which was loads of fun, as you can imagine.

We’ve set up and trained everyone to run our ISO 13 485 quality management system. We named our platform the NGX 1 24, and it is now officially CE-IVDR and UKCA marked.

Plus, we’ve tested all the consumables to make sure they’re diagnostic-ready.

This project has been a massive undertaking, taking two and a half long years. I can’t tell you how much work, stress, and problem-solving went into it. But this week, we finally got our first platform up and running—and it’s incredible. It’s hands down the highest-capacity qPCR molecular diagnostic platform out there, capable of running more tests at far lower cost than anything else.

Not only does the NGX 1 24 cost half as much to operate compared to other platforms, but it also cuts down on staff costs because a technician can operate it with just an hours training. This frees up biomedical scientists to work on more complex tests that need their skills, which, we hope will improve both revenues and staff retention in your labs.

We also wanted to give labs control over their testing options. So, our platform is completely open: it runs any assay type, including laboratory developed tests, research use only and regulatory-approved assays, that can be bought from independent assay and reagent manufacturers. This will drive down assay costs through competition and manufacturing economies of scale.

And, because it’s automated, it’s far more consistent than humans—no boredom, no hunger, no missed samples, reducing those costly handling errors that we so often saw during the high-throughput pandemic testing in the lighthouse labs.

To make things even easier for labs, there’s no upfront cost for the equipment. We lend the platform at no charge and just bill for the tests run—the more tests you run, the lower the cost per test.

Please contact me if you’re interested in partnering with us to help automate and cut testing costs in your lab with the NGX 1 24.

Richard Lewis, CEO, Fast MDx Ltd