In vitro diagnostics: essential tools for healthcare

The UK healthcare system is facing some big challenges: an ageing population; increasing number of people with multiple, chronic illnesses; and a need for future pandemic preparedness. To face these challenges, and to deliver an affordable and accessible healthcare system to patients, we need to create a more proactive healthcare system. 

If we can get better at identifying those in the earliest stages of disease, or those at risk of developing a disease in the future, our healthcare system will be better prepared. Interventions that could keep individuals healthy, or that quickly alert healthcare teams to those who are not, would reduce the need for more intensive care later on. 

An earlier diagnosis saves lives and healthcare costs

This emphasis on early disease and illness detection to deliver more effective treatments to patients presents a tremendous opportunity for the UK’s diagnostics industry. According to BIVDA, 70% of clinical decisions are influenced by the use of IVDs. And with the UK diagnostics industry turning over £820 million annually, supporting this industry and nurturing a UK-based innovation and supply chain is a great economic opportunity for the UK as a whole. 

We already know this works. Take the cervical smear test, offered to all women aged between 25 and 49. It is estimated that this testing programme has saved 6000 lives a year in the UK since its introduction. Not only do IVDs save lives, but in doing so, they save on the costs of treating patients with late-stage diseases. 

To better serve the needs of this industry, and specifically of promising UK HealthTech businesses, we are increasing our focus on IVDs to aid the development of cutting-edge rapid diagnostic and point-of-care testing solutions. 

We can help at every stage of development and commercialisation

Through state-of-the-art facilities and world-class expertise, we have been involved in supporting the HealthTech sector with IVD capabilities across a wide range of areas for many years. Our expertise across the biological, physical and digital space, and our skilled scientists, engineers and data experts means we are adept at horizontal innovation: bridging capabilities across these often-isolated spaces. Where required, these projects are conducted under our GMP or ISO13485 compliant Quality Management Systems. 

Our support is broad and customised depending on a company’s unique needs, from scaling up sustainable materials that make up the future of IVD devices, to detailed characterisation. For large companies, we can offer bespoke and specialised expertise to complement their in-house capabilities. While for smaller companies, who can often lack the space and internal expertise to develop and commercialise their innovative diagnostic products, we can bridge that gap for scale-up or production. 

Supporting SMEs through device development

We know that for SMEs in particular, it can be a real challenge to get a new idea to the next stage of development and beyond without external support. From biological material development, assay, and device development, to support for manufacturing at scale to feed into clinical validation. The varied and cross-cutting expertise found in our multi-disciplinary teams can be utilised by SMEs in this position.

At CPI, we have a human tissue licence that allows us to validate novel diagnostic and detection technologies with real-world clinical samples to enable companies to gather pre-clinical evidence that is so crucial to garner the interest of investors.

Supporting SMEs in meeting regulatory requirements for commercialisation

We know that SMEs not only struggle with the broad expertise and space required for product development, but also in accessing the niche knowledge required to navigate the regulatory landscape for IVDs. We are well placed to advise in this area, being home to experts with an in-depth understanding of IVD regulations and the standards needed to bring a device from a concept to commercialisation. Our teams can also offer clinical testing and evaluation support, providing an interconnected network across CPI to facilitate any customer’s IVD journey.

IVD devices are becoming essential tools for healthcare – critical for the improvement of outcomes, follow-on treatments and survival rates. They benefit both patients and providers by potentially reducing the costs associated with long-term complications.

By building on our already strong IVD capabilities, we are driving progress and accelerating the advancement of diagnostic devices. Our interconnected support – from an incubation or manufacturing space under ISO13485 accreditation, through to a pathway to commercialisation – across the entire IVD spectrum can enable companies to bring life-changing devices to market efficiently and effectively.