– Securing this highly competitive and prestigious grant represents a significant achievement for the company, says Prolight’s CTO Steve Ross.
Prolight Diagnostics is focusing on Point-of-Care (POC) testing, i.e. testing that take place close to the site of patient care. POC tests are performed outside the traditional hospital laboratory; e.g., in emergency departments, ambulances, healthcare centres or nursing homes.
The company’s digital POC technology, Psyros, allows for precise measurement of biomarkers at the single molecule level. The system has successfully demonstrated proof-of-performance for detecting low levels of troponin, a protein that is released into the bloodstream during a heart attack. The Psyros POC system paves the way for early detection and ruling out heart attacks, which could reduce healthcare costs by prioritising the right care to the right person.
Innovation grant from UK National Institute for Health and Care Research
Prolight Diagnostics has recently announced that it has been awarded a SEK 17 million UK government grant to support the development of the Psyros system.
– We are delighted to have been awarded this prestigious grant. i4i PDA grants are extremely competitive and this award gives external validation of the utility of our unique single-molecule-counting technology, said Ulf Bladin, CEO of Prolight Diagnostics.
The NIHR i4i Product Development Award is a funding opportunity provided by the UK’s National Institute for Health and Care Research (NIHR) as part of its Invention for Innovation (i4i) Programme. This programme supports translational research focused on medical devices, in-vitro diagnostic devices, and digital health tools that tackle challenges within health and social care. The award facilitates collaborative research and development of patient-focused technologies for adoption in the NHS or social care systems.
Prolight Diagnostics’ UK subsidiary, Psyros Diagnostics, is the lead grant holder. The grant is received in collaboration with King’s College London, Guy’s and St Thomas’ NHS Foundation Trust and the market access consultancy Lightning Health.
– Bringing the patient perspective to the development of innovative healthcare technologies is critical and we are very excited to be supporting Psyros Diagnostics with the pre-validation study for this digital POC technology, said co-applicant Charlotte Hamlyn Williams, Insights Manager at Lightning Health.
Pre-validation study of the troponin test
The grant will finance initiation of a pre-validation study at St Thomas’ Hospital in London and King’s College London, aiming to pre validate the performance of the Psyros assay and prototype. Patient samples will be used for final optimisation of the assay and the platform. Initial data will be generated in Q3 2024, and results are expected in Q4 2024.
– The data generated will be invaluable as we proceed into the full clinical performance validation study of the commercial POC system in 2025, says CEO Ulf Bladin.
Professor Michael Marber, consultant cardiologist at St Thomas’ Hospital and adjunct professor at King’s College London, will be principal clinical investigator in the trial.
– Stratification of patients at risk of heart attack relies on high-sensitivity troponin testing. Bringing these tests to the Point-of-Care allows faster decision making and earlier safe discharge of a large proportion of patients suspected of heart attack. We look forward greatly to collaborating on this project, said Michael Marber in a press release.
CTO insights
For further insights on the grant and pre-validation study, BioStock contacted Steve Ross, Chief Technology Officer (CTO) and Chief Investigator on this grant.
Could you elaborate on the purpose of the Invention for Innovation (i4i) Product Development Award (PDA) and how it supports Prolight Diagnostics’ goals?
– These awards are used to support collaborative projects between industry, universities and the NHS to aid in the development of new products that help to serve an unmet health need.
How does receiving this grant serve as an external validation for the Psyros system?
– Securing this highly competitive and prestigious grant represents a significant achievement for the company. In addition to the monetary value, it is reassuring to get external endorsement of the single-molecule-counting technology that lies at the heart of our system.
What are the criteria for obtaining this grant?
– The grants are limited to medical devices, in vitro diagnostics and digital health technologies. The application must be collaborative, usually combining a mix of industry expertise and clinical expertise. The application process consists of two stages. Successful applicants from the first stage are invited to submit a full application, which is subject to peer review by five independent referees. This is followed by an interview with a diverse panel that includes industry experts, clinicians, academics, patients and members of the public.
Who are your co-applicants and what are their roles?
– Prolight’s UK subsidiary, Psyros Diagnostics, is the lead applicant on the grant. Professor Michael Marber (Consultant Cardiologist at Guy’s and St Thomas’ NHS Foundation Trust and adjunct Professor of Cardiology at King’s College London) is a co-applicant and Dr Charlotte Hamlyn Williams from Lightning Health is also a co-applicant.
– Professor Marber provides oversight of the clinical work at St Thomas’ Hospital and is also a member of our clinical advisory board. Dr Charlotte Hamlyn Williams will take the lead on setting up the patient advisory group (PAG) and coordinating the role that the PAG takes throughout the project. This will include an initial visit of the PAG to our facilities in Kent, UK.
How does Prolight Diagnostics plan to allocate the funds from the grant towards advancing the development of the Psyros POC system?
– The funds are allocated according to a range of pre-defined work packages that were part of the grant application. These include project management, support for cartridge manufacture, pilot manufacture of prototype commercial instruments, pre-clinical evaluation with patient samples and set up of a patient advisory group.
What is the specific focus of the pre-validation study at St Thomas’ Hospital, and what are the expected outcomes?
– The pre-validation study will be the first time that prototypes are tested with fresh blood samples from patients with suspected heart attack. Our development work at our facility uses blood and plasma samples that are artificially spiked with troponin to simulate patient samples. However, real patient samples contain various forms of troponin, so it is critical to ensure that the system functions as expected with these samples. We will also be confirming that the system meets requirements for precision and that both whole blood and plasma give the same result.
How will the pre-validation study help you to secure an optimal outcome of the clinical performance validation study in 2025?
– The pre-validation study is fundamentally about de-risking the full performance validation study and giving us confidence that the system performs exactly as expected with patient samples. This then paves the way to ensure that our clinical study is executed in order to give the best possible data. The vast majority of chest-pain patients are not having a heart attack and a significant proportion of these can be safely discharged after a single troponin measurement (single point rule-out).
