Prolight Diagnostics har tagit fram nya data för sitt patientnära analysystem Psyros. Det gör att de är redo att inleda förvalideringsstudier på färska helblodsprover och sparade plasmaprover för mätning av troponin.
– The lower the detection limit of the system, the more accurately it can measure troponin at the relevant concentrations. This is where Psyros single-molecule counting system has a strong competitive advantage, säger Prolight Diagnostics’ CSO Aileen McGettrick.

Prolight Diagnostics utvecklar ett digitalt patientnära system (POC-system) för högkänsligt troponintest, med målet att snabbt och tidigt kunna bekräfta eller utesluta hjärtinfarkt. Bolaget förbereder för en kommande klinisk valideringsstudie som är planerad att starta i början av 2025. Den kliniska prestandastudien kommer att utgöra grunden för en regulatorisk ansökan inför kommersiell lansering 2026.

Som förberedelser för den kliniska prestandastudien kommer förvalideringsstudier att genomföras på en kombination av sparade kliniska prover och färska patientprover på brittiska sjukhus.

På väg mot förvalideringsstudier

Den 23 maj meddelade Prolight Diagnostics att de kan påbörja studierna baserat på data som genererats i helblodprover på den slutliga kommersiella testkortdesignen. Enligt bolaget möter datan de stränga krav som gäller för ”single-point rule-out” och riskstratifiering hos patienter med symtom på hjärtinfarkt.

– Att kunna mäta ner till låga ensiffriga ng/L-koncentrationer av troponin är avgörande för att leverera de bästa kliniska resultaten för patienter. Vi ser nu fram emot att bekräfta klinisk prestanda med ett större antal patientprover och tror att dessa starka data kommer att väcka globalt intresse, säger Prolights vd Ulf Bladin.

CSO berättar mer om datan

BioStock kontaktade Aileen McGettrick, CSO och medgrundare av Prolights dotterbolag Psyros Diagnostics, för att få veta mer om bolagets senaste resultat och kommande studier.

What are your responsibilities in the development and clinical validation of Psyros?

– As a co-founder of the technology I have been involved in many aspects of the development of the Psyros system since its inception in 2018.

– I currently have oversight of the R&D assay development team. My primary responsibility is final optimisation of the high sensitivity troponin assay formulation ready for clinical validation.

Could you explain the requirements for measuring troponin to detect or rule out myocardial infarction?

– The vast majority (>90 per cent) of chest-pain patients presenting to the Emergency Department (ED) are discharged safely without a diagnosis of heart attack. Tools that can help clinicians rapidly assess patients are of great benefit to patients and healthcare systems. Point of care testing can significantly reduce the time to diagnosis and accelerate discharge of patients from the ED.

»Tools that can help clinicians rapidly assess patients are of great benefit to patients and healthcare systems. Point of care testing can significantly reduce the time to diagnosis and accelerate discharge of patients from the ED.«

– Guidelines on the best clinical utility of troponin tests are provided by the European Society of Cardiology (ESC). These guidelines recommend the safe discharge of patients if their initial troponin measurement is sufficiently below a threshold concentration when coupled with no other significant clinical observations (single sample rule-out)

– If their troponin is slightly elevated (above the cut off for rule-out), then the next step is to understand if the troponin concentration is stable or changing. If their troponin level is stable over the course of 1 hour, then this also allows safe discharge of patients (serial measurement testing).

– The threshold concentration of troponin for single sample rule-out is very low, and the change in troponin concentration for serial measurements over 1 hour are extremely small. Therefore, the lower the detection limit of the system, the more accurately it can measure troponin at the relevant concentrations. This is where Psyros single-molecule counting system has a strong competitive advantage.

What evidence in the latest data suggests that the Psyros POC system meets these requirements?

– The true utility for point of care troponin tests is fast, safe rule out of chest pain patients. This has the potential for more efficient resource utilisation in the ED and cost savings for healthcare systems.

– The latest data were generated in whole blood samples on the final commercial cartridge design, which now incorporates internal cartridge quality controls ensuring every single test result is validated. We have demonstrated robust performance in the low single digit ng/L range. This range is typically where single sample rule-out thresholds are assigned, and gives confidence that the final validated assay will be suitable for single sample rule out and for use in risk stratification using serial measurements.

– The high sensitivity troponin assay is the first test to be developed on the novel Psyros platform. Meeting these stringent performance requirements for troponin demonstrates the excellent capability of the platform and the potential for adding many other assays to the test menu.

»Meeting these stringent performance requirements for troponin demonstrates the excellent capability of the platform and the potential for adding many other assays to the test menu.«

Finally, could you provide some details about the upcoming pre-validation studies?

– The pre-validation studies will help to de-risk full clinical validation of the Psyros high sensitivity troponin assay. This gives the final assurance before commencing the full clinical performance study required for regulatory clearance.

– The pre-validation study will verify clinical performance using a number of sample types targeted at specific areas. This includes:

• Stored samples from 700 healthy subjects to estimate the normal expected range (99^th percentile determination).
• Stored samples from 400 chest-pain patients (200 with confirmed heart attacks) to provide a preliminary estimate of clinical sensitivity / clinical specificity and the system’s ability to perform single sample rule-out (patients whose troponin concentration is sufficiently low when first measured upon presentation at the ED may be safely ruled out with a single measurement).
• Testing of the prototype Psyros system in situ at St Thomas’ Hospital, London as part of our collaborative i4i PDA award. This work will confirm troponin measurements from freshly collected whole blood and plasma from chest pain patients measured on the Psyros system are well correlated.

– Data from these studies will be generated over the coming months with results expected in Q3/Q4 of 2024.

Prenumerera på BioStocks nyhetsbrev