Prolight’s point-of-care (POC) system, Psyros, is built on a novel single-molecule counting technology that enables the detection of extremely low concentrations of biomarkers in blood. The company’s first product is a high-sensitivity troponin test, designed to help confirm or rule out myocardial infarction in patients presenting with chest pain.
The platform’s sensitivity allows healthcare providers to access laboratory-grade diagnostic precision directly at the patient’s side. According to the company, Psyros stands out from existing high-sensitivity POC systems by combining lab-level analytical performance with a simplified and cost-efficient consumable design. The compact, portable system can be used in a wide range of clinical environments — from emergency departments to ambulances and primary care clinics.
Strong preclinical feedback
Earlier this year, Prolight reported positive results from Guy’s and St Thomas’ Hospital in London, where Psyros was successfully tested using whole blood. The preclinical validation data have been very well received by potential commercial partners and end users, with both the system’s technical performance and the rapid pace of development drawing praise.
At present, Prolight is finalizing a series of design and manufacturing optimizations — a critical step to ensure long-term product reliability and scalability. The final implementation stages are underway, and procurement of components with long lead times has begun. The company aims to reach its assay design freeze — locking in the final design of the high-sensitivity test — before the end of the current quarter.
Scalable manufacturing in focus
In parallel with final instrument development, production of cartridges is being ramped up at manufacturing partner FlexMedical Solutions. The focus is on establishing consistent and reproducible production for verification and validation purposes.
Process validation for reagent manufacturing is also ongoing to secure a reliable supply of high-quality materials ahead of pilot production. Once the assay design is frozen and the instrument finalized, pilot instrument production will begin with partner Integrated Technologies Ltd (ITL).
Completing these final adjustments and internal validations before scaling up manufacturing is both critical and time-consuming. Multiple production batches are compared to ensure consistency across the board.
A noteworthy advantage for Prolight is that the preclinical studies utilized only a portion of the biobank and whole-blood samples from St Thomas’. The remaining samples will now be reserved for the final verification and validation phases — a significant cost saving, as the company avoids purchasing an additional, expensive sample set.
Strategic preparation for the clinical performance study
Alongside optimization efforts, Prolight is meticulously preparing for its upcoming clinical performance study in collaboration with contract research organization MDx. Qualification activities are ongoing for potential European hospitals, and the company is strategically selecting sites with extensive experience in complex diagnostic studies. According to CEO Ulf Bladin, detailed and methodical planning is absolutely crucial for the success of a study of this scale and complexity.
Proposed reverse stock split to strengthen investor appeal
To further enhance its attractiveness to institutional investors and strategic partners, the board has proposed a reverse stock split. While such a move does not change the company’s overall market capitalization, it can increase appeal among larger investors, who tend to prefer companies whose shares trade at a few dollars or euros rather than just a few cents.
In Prolight’s case, the proposal stems from ongoing discussions with potential partners and institutional investors. An extraordinary general meeting is scheduled for November 19, at which shareholders will vote on the reverse split.
Q&A with the CEO
BioStock spoke with CEO Ulf Bladin to find out more about the development.
You are now entering the final phase before the “assay design freeze.” What remains before reaching this milestone?
– We are completing the optimization of the test chemistry and ensuring that all components perform robustly in the commercial prototype. This includes fine-tuning reagents, verifying performance across multiple cartridge batches, and documenting design parameters for regulatory purposes. Once these steps are completed, the design is locked.
What does an “assay design freeze” mean in practice, and why is it such a key milestone?
– An assay design freeze means that the chemistry design of the test is finalized and will no longer change. It’s a critical milestone because it allows us to transition to validation, pilot production, and regulatory processes. Without a fixed design, manufacturing and clinical studies cannot proceed in a controlled and compliant manner.
You received very positive feedback from Guy’s and St Thomas’ Hospital. Which aspects of that feedback have been most valuable for your continued work?
– The most valuable insights have come from meetings with potential commercial partners, including at the ADLM conference. We’ve learned that our platform addresses a clear market need and is viewed as a breakthrough in point-of-care diagnostics. Feedback regarding performance, user-friendliness, and integration into existing workflows has been particularly helpful. These insights are guiding our commercialization strategy and product positioning.
You’re preparing the clinical performance study with MDx. How far along is the planning?
– Planning is well advanced. Site qualification activities have started, the study protocol is being developed, and logistics for sample collection and data management are being established. Our focus is on ensuring that all regulatory and quality requirements are in place before initiation.
You’ve described the upcoming performance study as complex. Could you elaborate on what makes it so, and how that affects planning?
– The study is complex because it will involve multiple clinical settings, a large number of samples, and the generation of the system’s own reference range using a large number of healthy normal samples. This requires careful coordination among many stakeholders, robust data collection processes, and adherence to stringent regulatory standards. Our planning therefore includes detailed risk assessments, layered quality controls, and clear communication structures between all involved parties.
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