– It is fair to say that the very positive results from the biobank study, on the first attempt, exceeded our expectations, and have reassured us that our system will deliver as promised. Now we are very excited to see the results from the clinical work at St Thomas’ Hospital, says Prolight’s CSO Aileen McGettrick.
Prolight Diagnostics’ Psyros point-of-care system leverages a novel single-molecule counting technology that can detect very low levels of biomarkers in blood. The company’s launch product will be a high-sensitivity troponin test. Troponin testing is an essential tool used to aid rule-in or rule-out of myocardial infarction in chest pain patients. The company recently announced positive results from a pre-clinical validation study using frozen plasma biobank samples and is now expanding on this work with a study on whole blood at St Thomas’ Hospital, London.
– The first pre-clinical study results are highly encouraging and affirm the performance underlying the Psyros technology. Our system evaluation using biobank samples demonstrated both very good analytical and clinical performance. Both aspects are critical features for use in clinical practice, said Ulf Bladin, CEO at Prolight.
A closer look at the pre-clinical studies
The pre-clinical results confirmed the POC system’s solid analytical and clinical performance. The first part of the pre-clinical study included duplicate measurements on 294 samples from healthy individuals, drawn from the ADLM (Association for Diagnostics and Laboratory Medicine) Universal Sample Bank. These biobank samples were used to evaluate the analytical performance, estimate the reference range and ensure the system is on track to meet the requirements of a high-sensitivity troponin assay.
The team also evaluated an additional biobank consisting of samples from chest pain patients. 94 chest-pain samples were tested, 46 of which were from patients with confirmed myocardial infarction.
– The results exceeded expectations and clearly demonstrated that the system is on track to deliver a high-sensitivity troponin assay, capable of rule-in and rule-out of myocardial infarction according to the European Society of Cardiology’s Guidelines for management of acute coronary syndromes, says CSO Aileen McGettrick.
Key first results from the whole blood study expected in Q2
Prolight is now progressing through the current whole blood study as part of the pre-clinical work at St Thomas’ Hospital in London. This phase involves fresh whole blood samples collected in real clinical settings and is crucial in demonstrating the system’s performance with whole blood compared to plasma.
– The upcoming results will be a significant milestone – not only demonstrating the functionality of Prolight’s POC-system with whole blood samples, but also providing more high-quality data for industrial partners and the broader market, says Ulf.
Many potential partners are awaiting these results with whole blood as a key pre-clinical validation before engaging in more concrete partnership discussions. If the outcomes are positive, they will serve as a clear signal that the POC system is ready for the next step.
Paving the way to commercialisation
With the successful first results from the pre-clinical validation studies, Prolight is now actively preparing for the full clinical performance study for regulatory approval. Discussions are ongoing with emergency departments at a range of clinical sites. At the same time, the company is actively engaging with potential strategic partners, setting the stage for future commercialisation.
– With a successful outcome in the pre-clinical validation studies, Prolight will be well positioned to move forward with a strategic partnership that will support both the completion of the full clinical performance study and subsequent regulatory approval, says Ulf.
Proligt Diagnostics plans to conduct a rights issue of 100,3 MSEK in June to finalise the development of Psyros and to strengthen its financial position in ongoing partnership discussions. Provided that shareholder participation is satisfactory, this capital raise would enable the company to reach commercialisation in Europe with its first assay: high-sensitivity troponin.
A conversation with Aileen McGettrick, CSO at Prolight Diagnostics
We reached out to Aileen McGettrick, Chief Scientific Officer at Prolight, to learn more about the implications of the data from the sample biobanks, the whole blood samples and what comes next.
This was the first time you tested a large number of patient samples on the Psyros platform. What was the purpose of these studies and what were your expectations going in?
– It is widely acknowledged that high-sensitivity troponin is a very technically challenging assay. We want to have confidence that the system will deliver before committing to our full regulatory clinical performance study evaluation. This pre-clinical biobank study allowed us to evaluate the combined performance of the assay chemistry, commercial cartridge and commercial prototype instrument to ensure we remain on track. Performance was benchmarked against our existing lab prototypes.
– There were essentially two key objectives of the biobank study: have confidence that we are likely to meet the stringent analytical demands of a high-sensitivity troponin assay and also demonstrate that we can achieve the clinical utility requirements of the test. It is fair to say that the first very positive results from the study exceeded our expectations.
How do the pre-clinical results compare with the established lab systems?
– These first preliminary results have shown that our performance will be comparable to commercial lab-based analysers, demonstrating both analytical and clinical excellence.
– The results indicate that our POC system will meet the stringent analytical demands of a high-sensitivity troponin assay and that we can achieve the clinical utility requirements of the test at the level of established lab systems.
– There are many advantages of a POC system vs established lab systems. First, a significantly shorter time to result, which will enable physicians to make an early and correct diagnosis and either rule-out or initiate the right treatment faster. Second, a portable POC system can be used by ambulance-based paramedics to make decisions in the community and potentially reduce hospital admissions.
How will the results from fresh whole blood samples at St Thomas’ Hospital complement the data from the biobank samples? Why are the results from the whole blood study so important?
– The biobank samples are frozen plasma that have been sourced from previous clinical studies and also from a wide range of healthy donors. Biobanks are an expedient way to demonstrate clinical performance. The Psyros system is designed to work using fresh whole blood samples, which can behave quite differently to plasma. Therefore, it is critical to demonstrate equivalence between plasma and blood samples across the target population, which is the primary purpose of the St Thomas’ study. If we can demonstrate equivalence, then we can infer that we will get the desired clinical performance in whole blood during the final clinical study.
Why did you conduct pre-clinical studies instead of a full clinical performance study?
– To avoid the cost and complexity of a clinical performance study at this stage, the best way to evaluate system performance is using frozen plasma samples from patient biobanks and complement them by comparing plasma with fresh whole blood from hospitalised cardiovascular in-patients. The combination of both data sets pave the way for the final clinical study for regulatory approval.
– We first generated data using samples from the ADLM biobank. These samples were collected from healthy non-disease state donors. The endogenous troponin levels are very low and representative of the general population. From an analytical perspective, it is essential that our assay can accurately and reproducibly measure these very low levels. Our study results showed that we can comfortably achieve this.
– The clinical utility aspect was evaluated using the chest pain biobank samples. These samples all have a definitive clinical diagnosis associated with them. This allowed us to demonstrate that we can accurately identify MI positive patients (clinical sensitivity) whilst reliably ruling out those who are MI negative (clinical specificity).
What do these powerful results tell you about the platform’s readiness for broader clinical use?
– Whilst preliminary, these data have shown that our performance is comparable to commercial lab-based analysers, demonstrating both analytical and clinical excellence. This puts us in a good position to optimise our POC system and complete product development ahead of our regulatory clinical performance evaluation study. It is very encouraging that we achieved this performance on our very first screen of a substantial number of patient samples.
– Our launch product will be for high sensitivity troponin tests but the future applications for the Psyros platform will be across many diverse clinical areas with various assays, including critical care as well as primary care. We have recently published a press release regarding some very interesting work carried out on our platform with cMyC which is another cardiac biomarker similar to troponin. The speed at which this assay was transferred onto our platform was really encouraging for when we progress to developing these future assays.
