Prolight Diagnostics går vidare med sin kommersialiseringsplan för point-of-care-systemet Psyros. Bolaget fortsätter att göra betydande framsteg i uppskalningen av tillverkningslinan för systemets engångstestkort. Detta är ett avgörande steg för att säkra de volymer som krävs inför den kommande kliniska prestandastudien. BioStock har talat med bolagets COO, Karl Bullen, för att få en fördjupad bild.

Prolight Diagnostics utvecklar en ny generation point-of-care-system (POC). Bolagets egenutvecklade plattform, Psyros, är utformad för att leverera laboratorieklassad känslighet i ett litet och portabelt instrument – en kapacitet som traditionellt har varit förbehållen stora, centraliserade laboratoriemiljöer. Systemet använder engångstestkort för att genomföra högkänsliga tester direkt i akutsjukvård och primärvård, med målsättningen att möjliggöra snabbare analyser som stödjer effektivare kliniska insatser och vård. Nyligen nåddes en viktig milstolpe när bolaget uppnådde så kallad ”assay design freeze” för sitt testkort. Med en fastställd design flyttas nu fokus till industrialisering.

Inriktning mot högvolymproduktion

Bolaget rapporterar nu betydande framsteg i uppskalningen av tillverkningen av dessa engångstestkort. Produktionslinan beskrivs som mycket modulär, ett designval som syftar till att möjliggöra snabb kapacitetsökning i takt med att efterfrågan växer. Enligt Prolight är målsättningen med den pågående uppskalningen att etablera en pilotlina som kan stödja volymer om över en miljon testkort per år i takt med att efterfrågan utvecklas. Denna kapacitet är avsedd att möta förväntad efterfrågan från framtida samarbetspartners samt säkerställa tillgången på testkort inför den kommande kliniska valideringen. En robust och tillförlitlig tillgång på testkort är inte bara avgörande för framtida kommersiell försäljning, utan även en förutsättning för bolagets operativa milstolpar på kort sikt. Den ökade produktionskapaciteten utgör en central del av förberedelserna inför den kliniska prestandastudien, där systemet ska valideras i klinisk miljö.

Balans mellan kostnad och prestanda

En central del av Psyros värdeerbjudande är kombinationen av mycket hög analytisk känslighet och låg produktkostnad. Medan traditionella högkänsliga system ofta är kostsamma, komplexa och centraliserade, har Psyros-plattformen utvecklats från grunden för att möjliggöra kostnadseffektiv tillverkning utan att kompromissa med den analytiska prestandan. Karl Bullen, COO för Prolight, betonar att denna balans är avgörande för att förändra marknadsförutsättningarna: – By achieving very high sensitivity at a dramatically lower cost, we are removing one of the biggest barriers to widespread adoption. This isn’t just an incremental improvement – it’s a step change in what’s possible. Fokuset på kostnadseffektivitet syftar till att möjliggöra bredare användning och att flytta tekniken från centrala laboratorier till kliniker, apotek och decentraliserade vårdmiljöer, både på utvecklade marknader och på tillväxtmarknader. – When you combine very high sensitivity, low cost of goods, and a truly portable device, you unlock entirely new use cases. That’s why we believe Psyros represents the future of point-of-care diagnostics, concludes Karl Bullen.

Interview with COO Karl Bullen (Q&A in English)

Karl, you announced that you are making important progress on the scale-up of the cartridge manufacturing. Can you explain what this means in practical terms for the team right now, and what the immediate priorities are on the production floor? – In practical terms, the current phase of scale up is focused on refining and validating the manufacturing processes rather than simply increasing output. The team is working in close collaboration with our partner Flex Medical Solutions on optimising each step of the cartridge production process to ensure it is repeatable, tightly controlled and suitable for high speed automation as volumes increase in the future. – On the production floor, immediate priorities include assessing process consistency at higher throughputs, identifying and addressing sources of variability, and ensuring that quality is maintained as production conditions evolve. This work is being carried out on the pilot line, which provides a controlled environment to test and improve processes under conditions that increasingly reflect future commercial production. – By investing time in process optimisation at this stage, the company is laying the groundwork for a smooth transition to higher-volume, fully automated manufacturing in the future, while maintaining the quality and performance standards required for point-of-care diagnostics

The objective is to support volumes of more than one million cartridges per annum as demand devlops. Is this capacity intended primarily for the initial commercial launch, or do you foresee further expansion after market entry?

– The pilot manufacturing line has been designed to be highly modular, providing a pathway for further capacity expansion following market entry, as demand develops across additional clinical settings and global markets.

Scaling up production often reveals new challenges regarding consistency. How are you ensuring quality control as you move from smaller batches to volume production on this pilot line?

– A key enabler of consistent quality at scale has been built into the Psyros cartridge from the outset. One of the core design principles during development was compatibility with automated manufacturing, which helps reduce the variability typically associated with manual processes. – Production processes have been developed and refined in close collaboration with Prolight’s contract manufacturing partner, Flex, with a focus on repeatability, process control and scalability. The pilot manufacturing line provides an important step in validating these processes under production conditions, allowing quality and consistency to be assessed and optimised as volumes increase. – This staged approach enables Prolight to build confidence in quality control ahead of any transition to higher-volume, fully automated manufacturing.

Have you secured the necessary supply chain for raw materials to support this ramp-up to one million cartridges, or are there bottlenecks you need to address?

– One of the key advantages of the Psyros cartridge is its deliberately low part count, which significantly simplifies the supply chain and reduces complexity as volumes increase. During the design phase, particular emphasis was placed on the selection of materials that are widely available and well established within existing manufacturing supply chains, avoiding the need for multiple bespoke or single-source supply arrangements. – This approach is intended to support supply-chain resilience and scalability, both for the initial commercial launch and for subsequent volume expansion. The supply chain is being established with the objective of supporting production beyond launch volumes, providing flexibility as demand develops.

The industry often talks about the difficulty of combining high sensitivity with low manufacturing costs. What is it about the Psyros technology that allows you to achieve this low cost of goods where others have struggled?

– Achieving high analytical sensitivity at low cost is often challenging because increased performance typically comes with greater system complexity. In the case of the Psyros cost efficiency has been designed from the outset rather than added later. – The core technology delivers high sensitivity through the underlying assay and detection approach, rather than through complex microfluidics or expensive sample manipulation. This allows the cartridge to remain physically simple, with a low part count and materials selected for large-scale manufacturability. – In parallel, the cartridge and manufacturing processes have been developed to be compatible with automation, helping to reduce variability and labour costs as volumes increase. These factors enable Psyros to target a low cost of goods while maintaining the analytical performance required for demanding point of-care assay like High Sensitivity Troponin —an assay where more complex or bespoke systems can face cost and performance challenges.

You talk about unlocking 'entirely new use cases.' What kind of markets or environments do you see opening up for Prolight thanks to this specific price-performance profile?

– The combination of a compact instrument and a low-cost, high-sensitivity cartridge opens up a range of use cases that have historically been difficult to address with existing point of care systems. The small footprint and portability of the Psyros instrument make it well suited to decentralised and space constrained environments such as ambulances, urgent care centres and other pre-hospital or near-patient settings, where rapid access to high quality diagnostic results can be particularly valuable. – At the same time, the low cost of the cartridge supports the commercial viability of a broad menu of tests, including use cases where testing volumes may be high but reimbursement levels are lower. This price performance profile has the potential to expand adoption beyond traditional hospital emergency departments into settings such as community healthcare, satellite clinics and resource limited environments, where cost and logistics have often been key blockers to point of care adoption until now. – Together these key attributes create opportunities for Psyros to address both established and emerging markets, enabling new applications at the point of care that have not previously been economically or logiscically feasible.

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