Prolight Diagnostics har utsett G&H | ITL för utvecklingen av sitt innovativa patientnära system, Psyros. Utvecklingsarbetet startade i början av 2023 och fortskrider enligt plan. BioStock kontaktade G&H:s vd Charlie Peppiatt och Prolight Diagnostics Head of Engineering, Paul Monaghan, för att få veta mer.

Prolight Diagnostics utvecklar Psyros, ett innovativt point-of-care system (POC) för snabb och tillförlitlig testning av biomarkörer, med hög känslighet och precision. Systemet utvecklas initialt för mätning av troponin för att upptäcka eller utesluta hjärtinfarkt.

Psyros representerar ett betydande framsteg för den patientnära diagnostiken och gör det möjligt för vårdpersonal att utföra diagnostiska analyser som tidigare varit begränsade till specialiserade laboratorier. Den digitala Psyros-tekniken har förmågan att räkna enskilda molekyler och därmed mäta mycket låga koncentrationer av biomarkörer från en droppe blod. Tekniken utvecklades ursprungligen av Psyros Diagnostics, ett brittiskt bolag som förvärvades av Prolight Diagnostics under 2022.

G&H | ITL – en utvecklingspartner specialiserad på medicinteknik och optik

Prolight Diagnostics har ett pågående samarbete med G&H | ITL för utveckling av Psyros-instrumentet. G&H | ITL är en CMO för medicintekniska produkter som ägs av Gooch and Housego (G&H), som är världsledande inom optik och fotonik. G&H | ITL tillhandahåller end-to-end design och utvecklings- och tillverkningstjänster för medicintekniska produkter, in vitro-diagnostik och laboratorieinstrument.

G&H | ITL har ett nära samarbete med Prolight Diagnostics för utvecklingen av Psyros-instrumentet – från koncept till färdigställande, inklusive prototyper och tillverkning i låg- och högvolym. Charlie Peppiatt, vd för G&H, delar med sig av sina tankar om partnerskapet till 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 och medgrundare av Psyros

Utvecklingen av Psyros-instrumentet leds av Paul Monaghan, en av de fyra grundarna av Psyros Diagnostics och Head of Engineering på Prolight Diagnostics. Paul tillför omfattande expertis till projektet, med över 20 års erfarenhet av in vitro-diagnostikutveckling och en doktorsexamen i lab-on-a-chip-system från Imperial College, London.

Innan Paul var med och grundade Psyros ledde han ingenjörsteamet på Vivacta, som förvärvades av Novartis 2012. På Vivacta ansvarade Paul för utvecklingen av instrumentet och testkortet i Niji-systemet, från tidigt designkoncept till CE-märkning.

BioStock fick möjlighet att ställa några frågor till Paul Monaghan om Psyros-teknologin och samarbetet med G&H | 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 vd ger en uppdatering om utvecklingen

BioStock kontaktade även Charlie Peppiatt, vd för G&H, för att få en statusuppdatering kring utvecklingen av Psyros.

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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