Prolight Diagnostics avslutar 2025 med starkt momentum

Marknaden för patientnära analyser (POC) växer snabbt, pådriven av behovet att flytta diagnostiken från centrala sjukhuslaboratorier, närmare patienten. Prolight Diagnostics utvecklar Psyros-systemet, en digital POC-plattform som är utformad för att leverera högkänsliga resultat med laboratoriekvalitet från en enda bloddroppe på bara 10 minuter.

I sitt vd-ord för bokslutskommunikén 2025 lyfter Ulf Bladin fram de betydande framsteg som tagits under det gångna året.

– During 2025, we took clear steps towards commercialisation; we presented positive patient data showing that the Psyros POC system delivers laboratory quality even in whole blood, showcased a fully functional commercial system prototype for the first time, and reached assay design freeze for the cartridge, konstaterar Bladin.

Stresstestar hårdvaran

Vägen till kommersialisering kräver rigorös testning. Under hösten genomförde Prolight en omfattande preklinisk utvärdering av 30 prototypsystem. Processen bekräftade systemets grundläggande tekniska prestanda, samtidigt som man identifierade ett fåtal riktade hårdvaruförbättringar för att göra systemet långsiktigt robust och för att säkra skalbar tillverkning.

Paul Monaghan, teknisk chef på Prolight, utvecklade nyligen värdet av denna utvärderingsfas i en intervju med BioStock.

– Evaluating 30 prototype units gave us a great opportunity to really put the system through its paces and confirm its core performance. Working with a batch of this size also allowed us to see how performance varies from instrument to instrument, giving us valuable insight into overall consistency.

Förbättringarna har nu implementerats i nära samarbete med utvecklingspartnern G&H | ITL, vilket gör att riskerna med att överföra instrumentet till pilotproduktion minskat avsevärt.

Skalar upp produktionen av testkort

Parallellt har bolaget tagit stora kliv i att skala upp tillverkningen av sina testkort tillsammans med FlexMedical Solutions. Den nya modulära produktionslinjen etableras för att kunna hantera volymer på över en miljon testkort per år i takt med en växande efterfrågan.

En central del av Psyros värdeerbjudande är förmågan att leverera hög analytisk känslighet till en låg produktionskostnad. Karl Bullen, operativ chef (COO) på Prolight, betonar varför detta ritar om spelplanen för branschen:

– 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.

Tar Psyros vidare till den avslutande kliniska prestandastudien

Efter den framgångsrika företrädesemissionen på 100 miljoner kronor i somras uppgick kassan till cirka 40,6 miljoner kronor vid årets slut. Bolaget går därmed in i 2026 med en stark balansräkning och ett tydligt fokus: slutlig systemverifiering, validering av tillverkningsprocesser, pilotproduktion och initiering av den avgörande europeiska kliniska multicenterstudien.

– With a clear and realistic timeline in place, we are advancing Psyros into its final clinical performance study. This milestone is being executed with rigor and discipline — without shortcuts and without compromising our steadfast commitment to delivering long-term value to patients, healthcare systems, society, and our shareholders, avslutar Ulf Bladin.

Vd kommenterar

För att få en djupare förståelse för de kommande milstolparna och de pågående partnerdiskussionerna har vi vänt oss till vd Ulf Bladin.

With the assay design freeze achieved and the hardware refinements finalised, you are now preparing for pilot production. What are the absolute most critical operational milestones you need to hit in the first half of 2026 to ensure the clinical multicentre study can start on schedule?

– The programme now enters a critical phase focused on disciplined operational execution and comprehensive risk mitigation in preparation for the multicentre clinical study. Two foundational milestones must be delivered to ensure the study can commence.

1. Completion of formal manufacturing process validation for the cartridge.

– The foremost operational priority is the execution and completion of full manufacturing process validation for the cartridge. This encompasses the definition, control, and verification of all critical process parameters under validated conditions. Assembly workflows, reagent loading procedures, in process quality controls, and final product release specifications must be rigorously established and demonstrated to be robust and reproducible.

– In addition, production consistency across multiple lots must be formally verified to ensure reliability of clinical supply. This milestone is essential not only from an operational perspective but also in supporting regulatory confidence. Without validated, repeatable manufacturing capability, the integrity, continuity, and compliance of clinical study supply would be materially compromised.

2. Achievement of formal instrument design freeze

– Equally critical is the attainment of design freeze for the instrument. The multicentre clinical study must be conducted on the definitive, or near-definitive, commercial configuration to ensure that all performance data generated is fully representative and directly transferable to regulatory submissions under EU IVDR and UKCA frameworks.

– Any substantive post-initiation design modifications would introduce significant regulatory and validation complexity, with the potential to impact timelines. A controlled design freeze therefore serves as a key risk-mitigation measure, safeguarding both the clinical programme and the broader regulatory strategy.

You mention in the report that the successful delivery of commercial prototypes and the design freeze have led to ”more structured and forward-looking discussions with several potential partners.” What specific attributes of the Psyros platform are these industrial players currently most interested in?

– The standout unique selling points for the Psyros system are:

• Very competitive cost of the disposable cartridge.
• Time to result for high sensitivity tests such as troponin.
• The proprietary POC technology with single molecule counting.
• Compact portable design of the instrument.

Looking beyond the technical milestones, your sights are firmly set on a commercial launch in 2027. How do you envision the initial market rollout for the Psyros system – are there specific geographical regions, healthcare settings, or patient segments you plan to target first to establish a strong market foothold?

– Looking beyond the technical milestones, our commercial strategy is very deliberate. We are planning an initial launch under EU IVDR and UKCA frameworks, prioritising markets where we can move efficiently within established regulatory pathways and reimbursement environments. Europe and the UK provide a strong foundation for early adoption, particularly given the clear clinical need and structured hospital networks.

– A key element of our rollout strategy is leveraging the reach and relationships of our commercial partners, who already have established market segments and distribution channels. This allows us to enter with scale and credibility, rather than building infrastructure from scratch.

– From a clinical standpoint, our initial focus will be Emergency Departments (EDs). EDs represent a high-impact setting where rapid, reliable diagnostic information can significantly influence triage decisions, patient flow, and clinical outcomes. Demonstrating clear value in this acute-care environment will be critical to establishing a strong market foothold.

– Following initial traction in EDs, we anticipate a rapid expansion into adjacent clinical areas including acute medical units, urgent care settings, and potentially other hospital and near-patient environments where timely decision-making is essential. Our goal is to build momentum then broaden adoption across additional clinical pathways.