Molecular diagnostics
Advanced molecular diagnostics at the point of need.
We are setting new standards in the development of reliable and effective molecular diagnostics – and have done so for nearly two decades. Building on extensive experience in integrating molecular workflows into high-performance, affordable and user-friendly devices, our platform and modular approaches to in vitro molecular diagnostic development now reduce time to market for our clients.
Comprehensive solutions for molecular diagnostics system development
As the fastest growing segment of in vitro diagnostics over the last decades, molecular diagnostics is seeing unabated demand for reliable systems for distributed labs, the point of care and the home. But bringing molecular assays closer to the patient faces key challenges – exacting standards of data quality and robustness need to be maintained without compromising on end-user simplicity and, above all, low-cost distribution.
TTP has developed systems that deliver sample-to-result molecular assays for nearly two decades. We provide comprehensive solutions for sample preparation, including tools for sample lysis, bead handling, and approaches to addressing both low- and high-volume samples. We are also proficient at integrating standard PCR and innovative amplification methods, with capabilities extending to advanced thermocycling techniques incorporating innovations beyond Peltier-based systems.
Partnering with TTP means working with an experienced and interdisciplinary team dedicated to supporting each stage of molecular diagnostics development, from concept generation to prototyping to delivering regulated manufactured products.
By partnering with TTP, our clients gain access to reliable, market-ready diagnostic systems that uphold the highest standards of quality for near-patient, point-of-care and home-based molecular diagnostics.
We chose TTP on the basis of ‘lowest risk/highest reward’. In particular I was impressed with the combination of TTP’s technical capabilities, structured approach and project management skills. The project was a great success because it had the right amount of innovation and practical engineering solutions; and all of the software development work went through the production and verification steps smoothly and on time (notable because project overruns frequently occur due to software failures). The first production units were delivered within the tight 12-month timeframe. This ensured that Atlas was on track with the timetable it had promised.
John Clarkson
Chief Executive at Atlas Genetics
The approach to liquid handling in the disposable is key to enabling easy translation from a lab-based protocol to product, thus providing fast-track and low-cost assay/protocol expansion.
Piers Harding
Inventor of the Puckdx™ technology at TTP plc
We initially approached TTP with our concept regarding personalised DNA testing. We were impressed by TTP’s desktop biology offering and saw an opportunity to accelerate the development of our technology and chemistry. TTP understands the fundamental steps required to convert lab-based biological processes to functional instruments. Working in partnership, we have been able to develop our product with TTP from concept to manufacture which, together with our database, will enable consumers to make more informed and healthy food choices, leading to improved health outcomes.
Professor Chris Toumazou
Co-founder and CEO at DnaNudge
Sequencing-based precision diagnostics
Sequencing is rapidly becoming a becoming a key pillar of modern diagnostics, with applications ranging from pathogen identification and genotyping to monitoring transplants or liver disease to informing personalised therapy choices and monitoring in precision medicine.
At TTP, Diagnostics and Omics teams work closely together to meet the unique challenges of sequencing-based diagnostics. Our efforts focus on creating simplified, distributable approaches to sample preparation. This includes pioneering methods for handling large volumes of blood and other bodily fluids and extracting nucleic acids for cell-free DNA analysis and low-prevalence pathogen identification applications.
Our expertise extends to optimising sample and library preparation for a variety of sequencing platforms, including next-generation sequencing (NGS), nanopore sequencing, and even capillary electrophoresis (CE), each suited to different diagnostic needs.
With this integrated approach, we are helping to shape a future where sequencing technology is readily available for more personalised, data-driven healthcare.
Have you considered isothermal amplification?
We’ve been interested in the potential of isothermal amplification methods for decentralised diagnostics for some time. Unlike PCR-based methods, which require thermal cycling, isothermal amplification operates at a constant temperature. This reduces power requirements and simplifies system design. Isothermal assays can also have greater tolerance to crude samples, minimising the need for extensive sample preparation.
These qualities make isothermal amplification an ideal choice for point-of-care testing, especially in settings where resources are limited. Indeed, during the Covid-19 pandemic we witnessed the rapid development and deployment of several systems for real-time testing outside traditional lab settings.
The design of isothermal assays does pose some challenges, but the effort can pay back through a simpler diagnostic system, paving the way for compact, cost-effective, and potentially recyclable devices that can be deployed at scale. Now the question is whether these isothermal, point-of-care technologies can evolve further into true at-home diagnostic solutions.
Explore how isothermal amplification is shaping the future of diagnostics and its potential for at-home solutions. Read our detailed insights here.
How we can help
Thermocycling methods
We leverage extensive expertise in designing high-performance thermocycling systems, including some of the fastest and most reliable PCR engines on the market. Thermocycling designs must address factors like fluid volumes, ramp rates, thermal uniformity, material selection, and cost. While many of the systems we’ve worked on are Peltier-based, we have also explored alternatives such as flow-through systems, resistive heating methods, and even laser and inductive methods, allowing us to deliver tailored solutions for any thermocycling needs.
Magnetic beads
Magnetic bead handling is a key step in assays for efficient biomolecule extraction and clean-up. We’ve invested to develop expertise in this area, using simulations to optimise the geometry of the fluidic pathway in the cartridge and specify the magnetic properties of capture mechanisms. Equally important, bead resuspension is achieved through fluidic or magnetic methods, or both. Rigorous testing validates our models and ensures reliable performance across a range of magnetic bead suppliers.
Sample extraction across different sample types
The sensitivity of any IVD relies heavily on the samples it receives and the effectiveness of the extraction system process. Fluid samples typically include swabs with media, whole blood, or sputum. For solid samples such as tissue, swabs or faeces, we design and integrate features into the cartridge to manipulate or macerate the sample to ensure efficient release of the DNA / RNA to be purified.
Manufacturing
We have successfully transferred many IVD instruments and cartridges into manufacture with OEM partners worldwide. As every project has different requirements, we try to find the right manufacturer early in the project, through evaluation, together with our clients.
Once selected, we involve the manufacturer in the design to ensure that we get their input as early as possible, especially important when product cost and quality is paramount.
We also generate a manufacturing transfer plan with the selected OEM and invite them to take part in early prototype builds at TTP so that they have a good appreciation of the challenges, ahead of the formal transfer.
Human factors
Usability is key to any successful IVD system. We therefore almost always include human factors engineers in our development teams to ensure that due consideration is given to how people interact with systems and equipment at work, and how to improve that interaction.
Our human factors activities are carried out in-line with EN 62366-1. We typically include formative studies in the early stages, using simple 3D prints and models, to gather feedback, which we use to influence the design.
Once the design is mature, we conduct summative studies by re-engaging with users to confirm that the design is not only intuitive, but ideally, a delight to use. Results from these studies become part of the Design History File.
Thermocycling methods
We leverage extensive expertise in designing high-performance thermocycling systems, including some of the fastest and most reliable PCR engines on the market. Thermocycling designs must address factors like fluid volumes, ramp rates, thermal uniformity, material selection, and cost. While many of the systems we’ve worked on are Peltier-based, we have also explored alternatives such as flow-through systems, resistive heating methods, and even laser and inductive methods, allowing us to deliver tailored solutions for any thermocycling needs.
Magnetic beads
Magnetic bead handling is a key step in assays for efficient biomolecule extraction and clean-up. We’ve invested to develop expertise in this area, using simulations to optimise the geometry of the fluidic pathway in the cartridge and specify the magnetic properties of capture mechanisms. Equally important, bead resuspension is achieved through fluidic or magnetic methods, or both. Rigorous testing validates our models and ensures reliable performance across a range of magnetic bead suppliers.
Sample extraction across different sample types
The sensitivity of any IVD relies heavily on the samples it receives and the effectiveness of the extraction system process. Fluid samples typically include swabs with media, whole blood, or sputum. For solid samples such as tissue, swabs or faeces, we design and integrate features into the cartridge to manipulate or macerate the sample to ensure efficient release of the DNA / RNA to be purified.
Manufacturing
We have successfully transferred many IVD instruments and cartridges into manufacture with OEM partners worldwide. As every project has different requirements, we try to find the right manufacturer early in the project, through evaluation, together with our clients.
Once selected, we involve the manufacturer in the design to ensure that we get their input as early as possible, especially important when product cost and quality is paramount.
We also generate a manufacturing transfer plan with the selected OEM and invite them to take part in early prototype builds at TTP so that they have a good appreciation of the challenges, ahead of the formal transfer.
Human factors
Usability is key to any successful IVD system. We therefore almost always include human factors engineers in our development teams to ensure that due consideration is given to how people interact with systems and equipment at work, and how to improve that interaction.
Our human factors activities are carried out in-line with EN 62366-1. We typically include formative studies in the early stages, using simple 3D prints and models, to gather feedback, which we use to influence the design.
Once the design is mature, we conduct summative studies by re-engaging with users to confirm that the design is not only intuitive, but ideally, a delight to use. Results from these studies become part of the Design History File.
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.
Software capability at TTP
Engaged in all stages of software and product development, our software capability at TTP covers the full spectrum—from in-depth analysis and system architecture to prototype design, implementation, and test development.
Manufacturing capability at TTP
Working seamlessly with our development teams, we take clients' products through prototype builds, clinical trials, pilot manufacture and more. Using TTP Manufacturing reduces uncertainty, risk and time to market for our clients.
Meet some of the team
Giles Sanders
Dan Gare
Piers Harding
