Prolight Diagnostics have appointed G&H | ITL for the development of its innovative point-of-care system, Psyros. The development project started in early 2023 and is steadily progressing. BioStock reached out to G&H’s CEO Charlie Peppiatt and Prolight Diagnostics’ Head of Engineering, Paul Monaghan, to gain further insight into the current status of development.

Prolight Diagnostics is developing Psyros, an innovative point-of-care (POC) system for quick and reliable testing of biomarkers, with high sensitivity and accuracy. The system is initially being developed for the measurement of troponin to rule-in or rule-out myocardial infarction.

Psyros represent a significant advancement in near-patient diagnostics, enabling healthcare professionals to perform diagnostic analyses that were previously confined to specialised laboratories. The digital Psyros technology has the capability to count single molecules, and thereby measure very low concentrations of biomarkers from a single drop of blood. The technology was originally developed by Psyros Diagnostics, a UK-based company acquired by Prolight Diagnostics in 2022.

G&H | ITL – development partner specialised in medical devices and optics

Prolight Diagnostics has partnered with G&H | ITL for the development of the Psyros instrument. G&H | ITL is a medical device CMO owned by Gooch and Housego (G&H), a world leader in optics and photonics. G&H | ITL provides end-to-end design, development and manufacturing services for medical devices, in-vitro diagnostics and laboratory instrument.

G&H | ITL works closely with Prolight Diagnostics to develop the Psyros device – from concept to completion, including prototyping, fabrication and low- and high-volume manufacturing.

Charlie Peppiatt, CEO of G&H, shares his thoughts on the partnership to BioStock:

“Psyros is ushering in a new era of precision medicine, and we take pride in helping Prolight bring this diagnostic technology to market. This partnership exemplifies our joint commitment to advancing healthcare through cutting-edge innovation.”

Paul Monaghan, Head of Engineering and Psyros co-founder

The development of the Psyros instrument is overseen by Paul Monaghan, one of the four founders of Psyros Diagnostics and Head of Engineering at Prolight Diagnostics. Paul brings extensive expertise to the project, with over 20 years of experience in in-vitro-diagnostics development and a PhD in lab-on-a chip devices from Imperial College, London.

Prior to Psyros, Paul led the engineering team at the VC-funded start-up Vivacta ltd, acquired by Novartis in 2012. In Vivacta, Paul oversaw the development of the Niji POC instrument and single-use test cartridge, from early concept through to a CE-marked product.

BioStock got the opportunity to ask Paul Monaghan a few questions regarding the Psyros technology and the development together with ITL.

Could you begin by describing the Psyros single-molecule counting technology and how it enables high sensitivity in detecting troponin and other biomarkers?

– Point of care assays have traditionally been seen as the underdog due to their inferior performance when compared to laboratory based testing.  When forming Psyros, forefront of our mind was how we can change this. It is well recognised that single-molecule counting formats provide the most sensitive assays. However, these systems are complex, expensive, and lab-based systems. The Psyros techology turns this on its head and enables single-molecules counting in a compact, cost-effective and simple format.

»Point of care assays have traditionally been seen as the underdog due to their inferior performance when compared to laboratory based testing.  When forming Psyros, forefront of our mind was how we can change this.«

– We count individual nanoparticles binding to a surface in the prescence of the analyte. The nanoparticles are so small they can not be seen by optical imaging methods. We overcome this by exposing the nanoparticles with light to generate dark spots within their vicinity on a fluorescent layer. The dark spots are much larger than the nanoparticle and can be easily imaged using our compact imaging module and counted using automated algorithms. The number of  dark spots is proportional to the analyte concentration in the blood sample. Its power is in its simplicity.

Are there other similar POC systems, or is this a new concept? 

– The curse of all measurement systems is signal to noise. This limitation excludes most point of care systems for challenging assays such as troponin and low-level biomarkers. We believe our Psyros single-molecule counting technology overcomes this and is truly unique giving us the edge in terms of performance and cost.

Why did you select G&H | ITL as partner for the development of the Psyros instrument?

– We appointed G&H | ITL as our development partner for the Psyros instrument following a competitive tendering process based on capabilities, previous experience and cost. G&H | ITL is a medical device CMO with combined in-house product development R&D. In 2018, G&H | ITL was acquired by Gooch and Housego, a well-established player in the photonics and precision optics field.

– The combination of G&H’s optical expertise and G&H| ITL’s medical device expertise was a natural fit to develop the Psyros system, especially considering that the Psyros system uses an optical imaging method to measure single molecule binding events. G&H | ITL is supplemented by an experienced team of engineers and scientists at Prolight to steer product development and rapidly evaluate designs to ensure the product meets our needs.

–  Moreover, G&H | ITL is ISO13485 certified for both R&D and manufacturing of medical devices, allowing a seamless transition from development into commercial manufacturing.

G&H’s CEO provides a development update

BioStock also reached out to Charlie Peppiatt, CEO of G&H, to get an update on the current status of the Psyros development.

First of all, what does the development team at G&H | ITL look like?

– The highly-experienced G&H | ITL development team consists of all the main engineering disciplines including optical, mechanical, electronics, software, industrial design and human factors engineering all overseen by a dedicated project manager.

Could you give us an overview of the development timeline?

– We started the project in early 2023 and the early phases of the project were directed towards development of the instrument’s compact optical module.  This optical module is the heart of the instrument, and the main challenge was shrinking a high-performance fluorescence microscope into a compact form in a cost-effective manner. This is essential to ensure we align with the needs of compact portable point of care device.

– With delivery of the compact optical module, the project has now moved onto the main commercial instrument prototype development phase and is on track to complete in late summer. This will result in delivery of a number of prototype instruments that will be combined with the test cartridge to allow Prolight to perform our internal product verification activities, ensuring the system meets specification. In parallel, the instrument design will be transferred to G&H | ITL’s manufacturing facility.  Instruments from the qualified manufacturing line will be used for clinical performance validation studies early in 2025.

»With delivery of the compact optical module, the project has now moved onto the main commercial instrument prototype development phase and is on track to complete in late summer«

Finally, why is it encouraging and rewarding to work with Prolight Diagnostics?

– Prolight Diagnostics’ forward-thinking approach to medical diagnostics is exemplified by the groundbreaking Psyros medical device. By partnering with Prolight, we are not just advancing technology; we are advancing patient care. Their dedication and innovation, combined with our expertise in design and manufacturing, allows us to make a tangible, significant impact in healthcare.

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