Prolight Diagnostics finalises cartridge design
Prolight Diagnostics has completed the design of the cartridge in the Psyros Point-of-Care system. The company’s manufacturing partner FlexMedical Solutions will use the design to develop pilot manufacturing processes, paving the way for clinical validation at the end of 2024.
– This is an important step forward for us in the development process, says COO Karl Bullen.
Prolight Diagnostics is developing Psyros, a portable Point-of-Care (POC) system for measurement of biomarkers at low concentrations. The system has been designed with the intention to support the rule-in and rule-out of myocardial infarction by accurately measuring troponin in blood.
Design finalised for commercial cartridge
The Psyros system consists of a simple and easy-to-use disposable test cartridge and a portable analyser.
Recently, Prolight Diagnostics announced that they have finalised the design of the Psyros cartridge, meaning that the commercial cartridge design has been completed. The company is now focusing on design transfer to its contract manufacturing partner, Flex Medical Solutions. Read more about the partnership here.
Competitive features
The finalised cartridge has several key competitive features, such as a simple design and ease of use. The cartridge is designed with cost-effective components, enabling manufacturing at large scale and low cost of goods.
– The Psyros cartridge has been designed to be very simple. Assembled from only four components, it can easily be produced at large scale using high levels of automation, says Prolight Diagnostics’ COO Karl Bullen in a previous article.
Multiplex-capable technology
The Psyros system is multiplex capable, meaning it can measure multiple biomarkers on a single test cartridge. Moreover, it is compatible with venous blood, fingerstick capillary blood and plasma samples. This ensures the system is versatile and future proofed for new multi-analyte applications.
The commercial cartridge will contain all the reagents required to complete the test, utilizing dried cartridge chemistry. This strategic approach minimises complexity and cost by eliminating the need for expensive liquid reagents/blister packs.
– Throughout the entire design process, each component has been carefully selected for manufacturability, with a strong focus on eliminating the need for complex features and assembly processes. The result of this focused effort is a cartridge design that can be efficiently manufactured from a small number of low-cost components.
COO comments on the development milestone
Biostock talked to Prolight’s COO Karl Bullen to learn more about the cartridge and development milestone.
Firstly, what are your primary responsibilities in the development of the Psyros system?
– As COO I am responsible for daily business operations of Prolight Diagnostics. I am based at the Psyros development site in the UK, where I work closely with the R&D management team to ensure we deliver the Psyros System ready for commercialisation in 2026.
Could you elaborate on the importance of reaching the final cartridge design milestone?
– The finalisation of the cartridge design is a key milestone as it allows our contract manufacturing partner to establish the pilot manufacturing process ready for validation. It represents the culmination of months of development work to ensure the design is both functionally robust and cost-effective to produce.
How do you ensure high quality while managing to maintain low costs?
– Every component has been carefully designed with high volume manufacturing as the focus. Everything from material selection to mechanical tolerances have been carefully modelled and tested extensively at the Psyros development site in the UK to ensure they meet the stringent Quality requirements of ISO 13485 and IVDR. The R&D team have focused on selecting commerically available components, avoided introducing exotic or bespoke materials to keep material costs low.
Could you explain the significance of multiplex-capable technology?
– The ability for clinicians to be provided with measurements of multiple biomarkers from a single sample, quickly and at the point of care will massively improve patient outcomes.
Now that the cartridge design is finalized, what steps will be taken next?
– The Contract Manufacturing partner Flex Medical Solutions is now developing the pilot line, the next step will be testing cartridges from the pilot line with prototype instruments from G&H ITL. Planned for Q3 24, this will allow us to put the system through its paces ahead of the formal validation.
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