Prolights CTO sätter fokus på CRO-partnern MDx

Prolight Diagnostics håller just nu på att slutföra utvecklingen av ett högkänsligt troponintest, som blir den första produkten att lanseras på immunoanalysplattformen Psyros för patientnära analyser (point-of-care). Psyros-plattformen möjliggör räkning av enskilda molekyler i en mycket liten volym helblod. Teknikens fördelar är den oöverträffade detektionsförmågan i ett litet bärbart instrument, i kombination med mycket konkurrenskraftiga produktionskostnader.

Fokus ligger just nu på en rad designoptimeringar med målet att nå en så kallad ”assay design freeze” (frysning av det högkänsliga testets design) före årsskiftet. Denna tekniska milstolpe är en förutsättning för den interna verifiering och validering som banar väg för bolagets viktiga kliniska prestandastudie.

Förberedelser inför den avgörande prestandastudien

Med de framgångsrika prekliniska resultaten från St Thomas’ Hospital i London tidigare i år i ryggen, har Prolight skiftat sitt operativa fokus till den detaljplanering som krävs för den regulatoriska kliniska prestandastudien under 2026. För att navigera genom de komplexa kraven i denna multicenterstudie – som ska genomföras i krävande akutmottagningsmiljöer – har Prolight valt MDx som sin CRO-partner (Clinical Research Organisation).

En CRO planerar, koordinerar och leder genomförandet av kliniska multicenterstudier och har ofta ett dedikerat team som hanterar logistiken och komplexiteten i sådana projekt. MDx är specialiserade inom in vitro-diagnostik (IVD) och medicinteknik, och erbjuder både kontraktsforskning och regulatorisk rådgivning. För närvarande ligger fokus på att kvalificera potentiella europeiska sjukhus och strategiskt välja ut kliniker med omfattande erfarenhet av komplexa diagnostiska studier.

– We are very pleased that Prolight selected MDx as their preferred clinical partner. The Psyros single-molecule-counting technology is very powerful and we are proud to be associated with Prolight, säger MDx vd Carlos Galamba.

Steve Ross, CTO på Prolight, tillägger:

– MDx have been a pleasure to engage with and we look forward to working with them on the clinical study that will generate the clinical data to launch the Psyros platform.

Ett samtal om att välja rätt CRO

BioStock talade med Steve om vikten av att välja rätt CRO och beslutet att anlita just MDx.

What is the motivation for developing a point-of-care test for high-sensitivity troponin?

– One of the main reasons that people present at emergency departments is because they display symptoms consistent with having a heart attack, also known as a myocardial infarction (MI). However, the majority of those subjects are discharged without a diagnosis of MI and high-sensitivity troponin assays play a key role in helping to diagnose MI and, particularly, in the rule-out of MI.

– A subset of patients can be ruled-out after their first troponin measurement, whereas others require a second measurement after one-hour to check if the troponin level is rising, falling or stable.

– There is a still an unmet need for a robust, reliable point-of-care system that meets all end-user requirements for the measurement of troponin in emergency departments and other settings, such as ambulances.

What are the complexities of a clinical study for a high-sensitivity point-of-care troponin assay?

– There are a number of factors that complicate these studies. First and foremost, the studies need to take place in the end-user setting of the emergency department. This is an overcrowded, busy environment, with many pressures on the staff. It can be challenging to obtain consent from patients in this environment.

– On top of this, multiple blood draws need to be taken over time in order to monitor changes in troponin concentrations, which can be logistically challenging. The total number of subjects required is high, because the majority of participants will be discharged safely and only a subset will actually receive a diagnosis of MI. This, in turn, requires multiple clinical sites to execute the study in a timely manner.

– In addition to the performance study on chest-pain patients, it is a requirement for high-sensitivity troponin assays to also carry out a healthy donor study, in order to define the reference range for each manufacturer, due to a lack of standardisation between tests.

What is the role of a CRO in a clinical study?

– CROs need to fulfil a wide range of roles and draw upon expertise from a number of different disciplines. They act as the interface between the manufacturer and the clinical sites, taking care of logistics, site selection and qualification, site set-up, training, protocol development, ethics approval, monitoring and data management, amongst many other tasks.

– Ultimately, Prolight, as the study sponsor, have accountability for all of these activities. However, a large number of tasks are delegated to the CRO to execute.

What was your selection process to choose which CRO to partner with?

– The screening process started with initial meetings with a number of CROs to assess their capabilities and expertise. This included large multinational CROs, in addition to more bespoke, smaller organisations in Europe, including Scandinavia and the UK.

– We then invited the top five CROs to provide us with full proposals on how they would execute the study, including indicative costs. Upon delivery of the proposals, we had follow-up Q&A sessions with each provider. We ranked them using a number of criteria, including:

• Costs and value for money.
• Professionalism and personal interactions.
• Experience and size of team.
• Experience with IVD trials, specifically troponin and point-of-care studies.
• Ability to provide regulatory support.

Why did you choose MDx as your preferred partner?

– There were a number of factors that affected our decision. As a small organisation, overall costs for study execution would always be a critical factor. However, there were a number of other reasons why MDx stood out for us. The top criteria were:

• MDx specialise solely in IVD and medtech, particularly in IVD. This is at the core of their offering and means that they are not distracted by bigger pharma studies or other priorities.
• They provided a very clear, well-worked proposal and responded rapidly to our queries.
• Although MDx are relatively small, they have a broad skill set, particularly around regulatory approval.
• Finally, they were always very professional, coupled with good personal interactions and a sense that they would be easy to work with.

What has your experience been with MDx to date?

– Although we initially selected MDx as our clinical partner to execute our full clinical study for regulatory approval, they have also helped us set up our research study at St Thomas’ Hospital in London. This study has provided us with fresh blood and plasma samples during the development phase of the Psyros platform.

– This “dry-run” at St Thomas’ has reinforced to us the critical role that a CRO plays and we were extremely happy with the service provided. The study has run smoothly and has been invaluable to the development process.

– In parallel we have been working with MDx on site selection, protocol development and general planning for our full clinical study in 2026. Overall, we are confident that we made the correct decision in selecting them for this critical role.