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Prolight have appointed Integrated Technologies Limited (ITL) to develop the instrumentation for our groundbreaking single molecule counting (digital) POC system, Psyros™. The program started in February 2023 and is progressing at pace.
“We believe the best approach is to partner with experts in their field who can help us deliver on our vision to develop ground-breaking products for our customers. Partnering with ITL gives us an outstanding combination of technical expertise, track-record, flexibility, longer-term manufacturing capability and regulatory compliance,” said Dr Paul Monaghan, Head of Engineering at Prolight´s subsidiary Psyros Diagnostics Ltd.
“We are excited to join the Psyros adventure as an external partner. The team is highly capable, and it has come up with a most innovative, yet simple and elegant new IVD technology which promises to improve point of care testing worldwide. We will bring our strong capabilities and skills in the field of optics, mechanical engineering, and intimate knowledge of the manufacturing process to the table,” said Tom Ackrill, Business Development Manager at ITL
ITL is a specialist design and development company with significant experience in medical devices. In addition to this, ITL has commercial scale manufacturing capability and is accredited to ISO 13485 & ISO 9001.
For over four decades, ITL has been an industry-leading outsource partner for true end-to-end design, development, and manufacturing of life-saving medical technology, diagnostic devices, and laboratory instruments. In August 2018, ITL was acquired by Gooch & Housego PLC. As part of the wider G&H Group, ITL has wide access to technology, expertise, and resources from the whole group.
MDx CRO is a globally recognised Contract Research Organisation specialising in clinical trials for diagnostics. MDx CRO is the contract research partner for the clinical performance study to validate the Psyros™ high-sensitivity troponin test. The collaboration will focus on the clinical validation of Prolight’s ground-breaking high-sensitivity troponin test. MDx CRO will be responsible for the preparation and execution of the upcoming multi-site clinical study of the commercial POC system, which is planned to start in 2025.
Flex Medical Solutions (FMS) is the contract manufacturing (CMO) partner for the Psyros™ disposable cartridge. Based near Edinburgh, Scotland, FMS specialises in contract manufacturing of disposable components for POC IVD systems. With ISO 13485 certification for the Development and Manufacturing of Medical Devices, FMS is extremely well-equipped for the manufacturing of the Psyros™ disposable cartridge.
Fleet Bioprocessing Ltd offer contract R&D and manufacturing services to the highest quality standards, with unrivalled expertise in immunoassay development, bioconjugation and related services.
The POC system MicroFlex is under development with The Technology Partnership (TTP). The platform combines well-proven ELISA technology into a microformat with the Flex Membrane-technology, developed by TTP. The combination of these two technologies, MicroFlex, has the potential to achieve equivalent test performance as hospital laboratories, in a format which make it suitable for widely distributed diagnostic testing.
In November 2022 Prolight signed a commercialisation agreement for its proprietary point-of-care (POC) platform MicroFlex with The Technology Partnership plc (TTP). Under the agreement, TTP will pursue further development and ongoing external initiatives and discussions with the aim of securing an industrial partner for MicroFlex. Prolight will benefit under the commercialisation agreement as future revenues are generated.
“We strongly believe in the MicroFlex technology but need to prioritise our resources. We chose TTP as our commercialisation partner as it has detailed knowledge of PLD MicroFlex and an extensive commercial network in the diagnostics market. TTP has the technical know-how and business development expertise necessary to pursue ongoing external initiatives and discussions, with the aim of securing the right industrial partners for MicroFlex. Through this agreement, Prolight Diagnostics will be renumerated as future revenues are generated,” said Ulf Bladin, CEO of Prolight Diagnostics.
“Having worked with Prolight in developing the MicroFlex platform, we are excited to be part of the next stages of its commercialisation. We look forward to fruitful discussions as we seek a commercial partner for the platform and the technology” said Giles Sanders, Head of Diagnostics at TTP.
TTP, The Technology Partnership, is a leading technology development business based near Cambridge, UK, with some 240 researchers and designers working with cutting edge companies all over the world, bringing advanced technologies to market.
