Introducing Diagnostics
Diagnostics solutions of the future delivered today.
With over three decades of experience in diagnostics, we have a proven track record of innovation, always working with our clients at the forefront of technology to invent disruptive but practical diagnostic systems that shape the future of healthcare. Now our key focus is on enabling the creation of innovative products and lab-quality diagnostics for distributed healthcare settings.
Expertise in biology, detection science, engineering and manufacturing design for diagnostics development
The development of new diagnostics calls for the delivery of high-quality repeatable assay performance, at an addressable market price, with instrumentation that delivers end-user simplicity, all developed with suitable regulatory considerations. We’re here to help you to meet this challenge.
At TTP, we understand that view diagnostic product development is a complex systems optimisation challenge. We bring together deep expertise in biology, detection science, engineering, manufacturing design and scale-up, allowing us to identify critical issues to help you make informed decisions that will underpin your product’s success.
With a track record of innovation and interdisciplinary depth, we support your mission from concept to manufacturing. Having partnered with many of the world’s leading diagnostics companies, we’re ready to help you achieve your goals.
The global demand for health equity is intensifying the demand for accessible diagnostic testing. Developers must reach beyond the confines of central lab facilities with decentralised solutions capable of delivering the same lab-quality results. To meet these needs, we offer IP building blocks and modular design methodologies to accelerate development and de-risk your project. Whether we’re working independently or as an extension of your development team, we will mobilise the precise skills and resources you need.
We work across the whole in vitro diagnostics market, but have extensive experience in Immunoassay and Molecular diagnostics.
Let’s work together to create transformative diagnostic products that advance global health and reach the patients who most need them.
ecoflex combines central lab quality quantisation with the affordability of lateral flow - all in a sustainable, paper-pulp design. Powered by the highly flexible MicroFlex fluidic technology, ecoflex simplifies the path of taking complex immunoassays out of the lab to the point-of-care, helping bring your diagnostics closer to patients, faster
Ben Metcalf
Project leader at TTP
This has the opportunity to be a truly transformative product in the field of management of UTIs – being able to provide guidance on treatment in 60 minutes and enable rapid confirmation of disease is an urgent need throughout the world.
Giles Sanders
Head of Diagnostics, TTP
We collaborated with Lumito in developing a novel tissue imaging system based on cutting-edge nanotechnology, significantly advancing diagnostic accuracy and enabling digitisation, automated analysis, and multiplex imaging in pathology. By uniting expertise in chemistry, immunoassay, and optics, we provided an integrated development on both the NIR imaging system and novel UCNP reagents, delivering unmatched imaging precision, addressing key challenges in cancer diagnostics and shaping a brighter future for patient care.
Wenshu Xu
Consultant at TTP
Design for very low cost and sustainability
IVD tests are major users of plastics – be this the packaging of a lateral flow test or the number of tips and plastic storage containers used in central-lab testing.
At TTP we are always exploring ways to reduce plastic use. At the simplest, translating processes into single-use disposables with integrated liquid handling can, in itself, reduce plastic use.
Similarly, advanced detection systems – enabling rapid antimicrobial resistance testing (AST) for example – reduce plastic use by avoiding plating and transport containers. Different methods of delivering fluids offer opportunities to reduce or remove tip usage too.
We need solutions to further reduce material use – ecoFlex is an example of our thinking: a system that uses a film and paper pulp-based cartridge providing single ELISA with <2g of plastic use. Looking to the future, we continue to explore materials and engineering solutions to deliver more sustainable IVD devices.
Discover more about our innovative approaches to sustainable diagnostics—explore our insight on a new low-plastic immunoassay platform delivering lab-quality results at the point-of-care here.
UTI Diagnostics: An opportunity to improve antimicrobial stewardship and women’s health
Women’s health has historically been overlooked by much of the medical world, but times are changing. Innovation in diagnostics can lead the way to improving women’s health and well-being throughout their life.
Urinary tract infections, or UTIs, are a case in point. Most women will develop at least one UTI in their life, but current diagnostics for UTIs take up to 2 days. Too often treatment is started without proper diagnosis and with an inappropriate antibiotic, which ultimately fuels antimicrobial resistance (AMR).
Faster systems to diagnose bacterial and fungal infections at the point of need and detect antibiotic susceptibility are key to improving the outcomes of patients with UTIs. TTP and ODx Innovation have developed a platform that detects bacterial growth associated with an infection in under 20 minutes and determines antibiotic susceptibility to 6 antibiotics in 1 hour. This diagnoses the infection and enables the selection of the best course of treatment.
Learn how rapid diagnostic platforms are transforming UTI management and advancing antimicrobial stewardship. Read our latest insights here.
Monitoring of infectious diseases
As we look to a future with a greater government and public awareness of the risks and impacts of pandemics, technologies for local and environmental monitoring become more important. We are currently exploring and working on methods for continuous detection of environmentally sourced nucleic acids and for distributed high-quality pooled screening.
How we can help
Software development
Our consultants have extensive expertise in diagnostics software development, and we work closely with our broader TTP Software team to scale and meet the needs of your devices, regardless of their class.
Medical device cyber security
Considering both hardware and software, we can support development and requirements for cyber security concerns
Compliance
Our development process is ISO13485:2016 compliant. Working with our clients, we move towards suitable regulatory controls as the programme evolves.
As part of the regulated development, we ensures that Requirement Capture, Programme Planning and Risk Management are managed through the relevant development lifecycle.
If needed, we can help our clients with the ‘Intended Use’ statement, and once this is available, we typically undertake a regulatory review to identify applicable directives and standards. These can include EMC, Electrical Safety, RoHS & WEEE, and others.
Central lab automation
If your needs concern central lab systems, we can support your development. With our extensive experience in automation, innovative thinking, and expertise in sensing, we can deliver improved central lab solutions.
Manufacture
Establishing a manufacturable product is clearly key to the success of any programme. That is why we consider manufacturability throughout any development.
Our network of manufacturing partners can be engaged early to ensure additional considerations are taken into account and to address any manufacturer-specific needs.
During any development, we engage our own internal manufacturing team throughout. They ensure that our clients can have suitable numbers of prototypes of cartridges and instruments to support their testing during a programme.
Additionally, we can continue to build instruments and cartridges for you (to ISO13485) at volumes suitable for clinical trials and early sales. We can then support transfer to a scale manufacturer.
Post-launch
Once production is stable, we typically drops away from the project unless the client wishes otherwise. We are always ready to re-engage. This can occur when and if the client wants to start the development of Gen 2 or if there is a step change in specification that requires a level of redesign.
Clinical trials and 510k submissions
Although the responsibility of our clients, we can provide manufacturing support and technical expertise during the clinical trial. Our Design History Files also provides data and supporting evidence for the 510k submission.
Software development
Our consultants have extensive expertise in diagnostics software development, and we work closely with our broader TTP Software team to scale and meet the needs of your devices, regardless of their class.
Medical device cyber security
Considering both hardware and software, we can support development and requirements for cyber security concerns
Compliance
Our development process is ISO13485:2016 compliant. Working with our clients, we move towards suitable regulatory controls as the programme evolves.
As part of the regulated development, we ensures that Requirement Capture, Programme Planning and Risk Management are managed through the relevant development lifecycle.
If needed, we can help our clients with the ‘Intended Use’ statement, and once this is available, we typically undertake a regulatory review to identify applicable directives and standards. These can include EMC, Electrical Safety, RoHS & WEEE, and others.
Central lab automation
If your needs concern central lab systems, we can support your development. With our extensive experience in automation, innovative thinking, and expertise in sensing, we can deliver improved central lab solutions.
Manufacture
Establishing a manufacturable product is clearly key to the success of any programme. That is why we consider manufacturability throughout any development.
Our network of manufacturing partners can be engaged early to ensure additional considerations are taken into account and to address any manufacturer-specific needs.
During any development, we engage our own internal manufacturing team throughout. They ensure that our clients can have suitable numbers of prototypes of cartridges and instruments to support their testing during a programme.
Additionally, we can continue to build instruments and cartridges for you (to ISO13485) at volumes suitable for clinical trials and early sales. We can then support transfer to a scale manufacturer.
Post-launch
Once production is stable, we typically drops away from the project unless the client wishes otherwise. We are always ready to re-engage. This can occur when and if the client wants to start the development of Gen 2 or if there is a step change in specification that requires a level of redesign.
Clinical trials and 510k submissions
Although the responsibility of our clients, we can provide manufacturing support and technical expertise during the clinical trial. Our Design History Files also provides data and supporting evidence for the 510k submission.
Our approach and capabilities
We deliver across the entire life of a project, from opportunity discovery to production engineering. Discover how our interdisciplinary teams of experts collaborate to tackle the toughest product development challenges.
Our campus and facilities
Our award-winning campus has been designed with a clear vision. To create a space which can support our people and our clients as we develop and deliver the very best technology solutions.
Meet some of the team
Giles Sanders
James Stein
Tim Keating
