We had the opportunity to sit down with Dr. Aileen McGettrick, Chief Scientific Officer at Prolight Diagnostics, located at Discovery Park. With Prolight entering a phase of rapid growth, we were eager to learn more about their innovative new technology and what it means for the future!

 

 

Can you share more about the technology you are developing and how it will help people?

Prolight Diagnostics is developing a point of care (POC) blood testing system based on proprietary single molecule counting technology capable of detecting extremely low levels of biomarkers in 10 minutes or less.

The technology originated 2018 in start-up Psyros Diagnostics Ltd, of which I’m one of the 4 co-founders. After acquisition of the company by Prolight Diagnostics in 2022 the POC system itself has now been branded Psyros™.

The Psyros™ system consists of a portable instrument and single use disposable cartridge that requires only a drop of blood to perform a test. It has been designed to be simple, easy to use near the patient, with a very competitive low cost. With the ability to multiplex and measure several biomarkers at the same time it has huge potential.

The ambition is to have test results available to doctors within ten minutes to allow rapid diagnosis and treatment when the patient is examined the first time, instead of spending critical time waiting for results from a hospital laboratory. Potential settings include the emergency department (ED), healthcare centres, ambulances, and care homes.

Initially, our cutting-edge technology is being used to develop a diagnostic POC test that measures the protein troponin with high sensitivity and accuracy, to aid in the rule-in and rule-out of heart attack. By measuring troponin, which is released from the heart into the bloodstream during a heart attack, the test helps to make a rapid diagnosis.

The vast majority (>90%) of chest-pain patients presenting to the ED are discharged safely without a diagnosis of heart attack. Tools that can help clinicians rapidly assess patients are of great benefit. The true utility for POC 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 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.

 

 

Why did you choose Discovery Park as your base of operations, and how has the location benefited your company?

We chose Discovery Park initially in 2020 as the four founders of Psyros were all based in Kent. We were looking for a small lab with associated office space that we could expand as the company grew. During those early years, we also wanted to be part of a community with other start-ups and benefit from the support Discovery Park offered for networking and potential fundraising.

After the acquisition of Psyros by Prolight in 2022 we expanded rapidly and now have 20 staff based here and occupy over 5x our original space.

 

 

What recent milestones or achievements is Prolight Diagnostics most proud of?

The product development of the Psyros™ system has been progressing at speed over the last few years leading to many achievements that we’re very proud of.

Our plan is to develop and finalise our platform all the way to a commercial POC system that is ready for clinical validation by the end of 2024.

Key milestones have included proof of performance for our high sensitive troponin assay in whole blood down in the single digit ng/L range, gaining our ISO13485 accreditation and selecting external partners for the instrument and the cartridge manufacture.

Receiving a prestigious NIHR i4i Product Development Award (PDA) early this year for £1.26M was a great achievement and is external validation of the utility of our unique technology. The grant which is in collaboration with among others, Guy’s and St Thomas’ NHS Foundation Trust, and King’s College London will help support the final stages of product development through to launch. This includes pilot manufacturing of instruments, initial clinical studies with patient samples, technical file submission and set-up of a patient advisory group.

 

 

How does Prolight Diagnostics stay ahead of the curve in the rapidly evolving field of diagnostics?

Our unique technology opens the possibility of developing new POC tests in a wide range of clinical areas that were previously only possible in specialised laboratories.

Some examples of possible future clinical areas are neuropathology (dementia, traumatic brain injuries), immune system dysfunction (sepsis, autoimmune diseases) and rapid virus detection such as Covid.

 

 

What does the future look like for Prolight Diagnostics, and what exciting developments can we expect to see in the coming years?

We are now ready to initiate studies on both banked clinical samples, and fresh clinical samples in UK hospitals. This includes, as part of our i4i PDA award, testing the Psyros™ high sensitivity troponin assay at St Thomas’ Hospital in London with patient blood samples.

These pre-clinical studies are designed to precede and de-risk our full clinical performance study planned for early 2025. This large performance study will validate the system and generate data for regulatory approval in Europe. The launch of our first product, the Psyros™ high sensitivity troponin assay, will follow in 2026.

Troponin is only the start, Psyros™ is a platform technology capable of measuring many other biomarkers in blood. The unique technology and multiplexing capabilities will make it possible to test a range of biomarkers with high sensitivity and accuracy on a single POC instrument.