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Promotional graphic titled “Driving Performance Through Single Molecule Counting” showing a Prolight handheld diagnostic device and icons highlighting sensitivity, small sample size, fast results, multiplex assays, competitive cost, and whole blood use.©️ Prolight Diagnostics Psyros™ platform, next-generation point-of-care diagnostic system

G&H | ITL Case Study: Psyros™ Point-of-Care System

Technical

Overview

Prolight Diagnostics is redefining what is possible in near-patient testing with its Psyros™ platform - a next-generation point-of-care (POC) diagnostic system capable of detecting biomarkers at single-molecule level sensitivity from just a drop of blood.

Designed to deliver laboratory-quality results in under 10 minutes, Psyros™ has the potential to transform how critical conditions - such as myocardial infarction - are diagnosed, enabling faster clinical decisions and improved patient outcomes.

To accelerate the transition from breakthrough concept to commercially viable product, Prolight Diagnostics selected G&H | ITL as its development and manufacturing partner.

Together, the teams are advancing Psyros™ from prototype to a robust, scalable diagnostic platform - laying the foundation for clinical validation and commercial launch.

The Challenge

Point-of-care diagnostics have historically faced a trade-off: speed and convenience at the expense of sensitivity and accuracy.

While single-molecule detection methods offer unparalleled sensitivity, they have traditionally been confined to complex, expensive laboratory systems - far removed from near-patient settings.

Prolight Diagnostics set out to overcome this limitation by developing a system that could:

  • Deliver ultra-high sensitivity comparable to central laboratories
  • Operate in a compact, portable format
  • Provide results in minutes, not hours
  • Maintain a low cost of production for widespread adoption
  • Be scalable and compliant with stringent IVD regulatory requirements

However, translating this novel technology into a manufacturable, regulatory-ready instrument required deep expertise across optics, engineering, and medical device development.

Technician inspects a circuit board under a stereo microscope at a laboratory workbench.©️ G&H | ITL

The Solution

G&H | ITL partnered with Prolight Diagnostics to design and develop the Psyros™ instrument - combining advanced photonics expertise with end-to-end medical device engineering.

The collaboration spans:

A key milestone has been the successful development of the compact optical module - the core of the Psyros™ system - enabling detection of single-molecule binding events through a simplified imaging approach.

The program has since progressed into commercial prototype development, with multiple instruments delivered for validation and testing.

A close-up image showing a healthcare professional using the Psyros™ diagnostic device from Prolight Diagnostics. The device has a sleek, compact design with a touchscreen displaying test results for Troponin I, reading "1.2 ng/l." In the background, a gloved hand is performing a finger-prick blood test on a patient. The overall setting suggests a point-of-care testing environment.©️ Psyros™ Diagnostics Ltd.'s Psyros™ Point-of-Care System © Prolight Diagnostics

Progress and Impact

The collaboration has rapidly advanced Psyros™ toward commercialization:

  • Delivery of 30 commercial prototype instruments for pre-validation and stress testing
  • Successful pre-clinical validation demonstrating laboratory-quality performance, including in whole blood
  • Ongoing clinical studies to support regulatory approval
  • Transition toward pilot production and manufacturing scale-up

This progress significantly reduces technical and manufacturing risk while ensuring the system is optimized for real-world clinical use.

At its core, Psyros™ introduces a fundamentally new approach to point-of-care diagnostics:

  • Single-molecule counting technology for unprecedented sensitivity
  • Rapid results (<10 minutes) from a small blood sample
  • Multiplex capability for detecting multiple biomarkers
  • Low-cost, scalable cartridge design

Together, these capabilities position Psyros™ as a potential step change in decentralized diagnostics - moving high-performance testing closer to the patient.

Prolight Diagnostics Psyros™ point-of-care diagnostic device with a touchscreen display, shown with a hand placing a test cartridge onto the illuminated base blue background.©️ Prolight Diagnostics Psyros™ platform, next-generation point-of-care diagnostic system

Customer Perspective

“Partnering with G&H | ITL gives us an outstanding combination of technical expertise, track-record, flexibility, longer-term manufacturing capability and regulatory compliance.” 

- Dr. Paul Monaghan, Head of Engineering, Psyros Diagnostics

Looking Ahead

With prototype validation underway and manufacturing processes being established, Psyros™ is entering a critical phase:

  • Final clinical performance studies
  • Regulatory submissions under IVDR and UKCA frameworks
  • Preparation for commercial launch

As the program progresses, the collaboration between Prolight Diagnostics and G&H | ITL continues to focus on delivering a system that is not only scientifically advanced, but also manufacturable, scalable, and ready for global deployment.

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Solutions

Prolight Diagnostics and G&H | ITL - Precision Manufacturing for Point-of-Care Diagnostics

Explore the Psyros™ device and its potential to transform high-sensitivity point-of-care testing. The video highlights how precision engineering, device development and scalable manufacturing support the delivery of advanced diagnostic technologies.

Psyros in the Media

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