Psyrois Prolight Diagnostics digital point-of-care analysis platform designed to detect low levels of troponin in the blood, enabling a rapid and reliable diagnostic tool for myocardial infarction. The system consists of a portable analysis device and a disposable test card, and only a drop of blood is required to perform the test.
Partnership with FlexMedical Solutions
In March, Prolight entered into a contract manufacturing agreement with FlexMedical Solutions (FMS) for the production of the single-use test card in the Psyros system. FlexMedical has extensive experience in manufacturing processes for IVD products and expertise in fully validated facilities.
During the second quarter, Prolight completed the design of the test card for commercial use. FMS has since made significant progress in building the pilot production line to support regulatory approvals, as well as the clinical performance study and production volumes required for commercial launch.
Business review shows progress
Prolight Diagnostics recently conducted a review of FMS progress, which included a thorough inspection of the pilot production line and its associated support facilities.
- It was exciting to see the significant progress FMS has made over the last few months. With building works now complete, it was great to see the first wave of production equipment being installed, commented Prolight Diagnostics COO Karl Bullen.
Simple design, streamlined production and competitive cost
The manufacturing process and test board are designed to enable large-scale production, with a high degree of automation and low production costs. The test board consists of few components that have been carefully selected for efficient and streamlined production. This method not only allows for outsourcing of manufacturing, but also very competitive costs.
COO comments
BioStock contacted Prolight Diagnostics COO, Karl Bullen, to learn more about the progress of the collaboration with FMS.
Can you share more details on the progress FMS has made in recent months, and the key findings from your recent business review?
- FMS has completed the building works for the pilot line and the co-located laboratory. This is a significant step, as the completion of this phase now allows for the installation of equipment to begin.
– One key finding from the business review highlighted that FMS are well organized with good project governance processes giving Prolight high levels of confidence that they will continue to deliver. During the business review, FMS also demonstrated a number of innovative solutions they have put in place to optimize the build process and minimize costs.
What are the upcoming steps in setting up the cartridge manufacturing process?
- The most significant upcoming steps will be the delivery of bespoke manufacturing equipment, which is currently being built by specialized equipment supplier.
With a clinical performance study on the horizon, how is Prolight Diagnostics preparing for this upcoming step, and how will the pilot line support those efforts?
– Prolight is currently fully focused on completing pre-clinical studies to derisk the formal clinical performance study planned for 2025. Cartridges produced by the pilot line will be used for the clinical performance study.
How do you envision the partnership with FMS evolving as Prolight moves towards full-scale production and market launch?
– Once the pilot line is established, we will continue to work with FMS to optimize the production process whilst in parallel work towards the development of the high-volume commercial line required for the years following launch.
