The world of diagnostics has grown significantly over the past few years. The industry is not only focused on specific disease identification, but is also responding to personalised and stratified medicine initiatives, supporting a larger number of clinical developments, developing tests to monitor progression of often overlapping disorders and advancing predictive testing capabilities.
When combined with continued interest in not only lab based systems but also portable point of care tests in hospital, clinic and home environments, diagnostics companies have a number of market opportunities to respond to.
The fundamental focus of Sagentia's work is to achieve faster time to market for complex science and technology challenges and highly customised design requirements. This includes developing instruments with higher levels of sensitivity, platform flexibility and throughput, as well as ensuring that size, cost and usability requirements are successfully addressed. Importantly, we have deep expertise across novel consumables, complex diagnostics systems with simple user interfaces and modular instrumentation.
With expertise across a number of application areas including molecular, haematology, immunochemistry, genomics, lateral flow and clinical chemistry, we work with start-ups and global multinationals alike from front end innovation, through product design and development, to successful transfer to manufacture.
Recent examples of project work for clients operating in the diagnostics sector include:
- The design and development and of a real-time PCR-based diagnostic unit which was central to the subsequent development and transfer to manufacture of the full system, The PoC unit has undergone full clinical trials and has been successfully launched into the market.
- The thermal and optical modelling of the key component in a complex PoC consumable. Our input resulted in a production ready design suitable for high volume manufacture
- Significant cost savings for a sophisticated hand held diagnostics device. This was achieved by undertaking a structured Product Challenge project based on concept generation and Design for Manufacture and Assembly (DFMA) principles. The project also led to a range of quality improvements over the existing product
- The in-house development of a platform using coded functionalised beads for multiplexed DNA and protein assays. Sagentia’s interdisciplinary team developed proof-of-concept for the entire system including bead manufacture, surface functionalisation and detection, prior to the technology being spun out and subsequently licensed. Additional assay development work includes a toxicology assay designed for the Luminex® bead platform on behalf of a major pharmaceutical company