DECIPHER: Redefining point-of-care diagnostics

When a suspected case of Ebola or Lassa fever appears in a remote health clinic, the clock starts ticking. The symptoms – fever, fatigue, headache – resemble many other common illnesses, yet if the patient is carrying one of these highly dangerous viruses, early detection can make the difference between containment and a rapidly escalating outbreak.

Today, confirming such infections usually requires centralised laboratory PCR testing. Samples must be transported, processed by trained personnel and analysed using specialised equipment. Even under ideal conditions, results may take a day or more and in remote regions, delays can stretch far longer.

For healthcare systems already under pressure, those lost hours can have serious consequences. In practice, diagnosis often begins with non-specific symptoms alone, before samples are taken and sent to a laboratory for confirmation. During that time, exposure may already be happening.

The challenge highlights a persistent weakness in global outbreak response: the ability to obtain reliable diagnostic information directly where care is delivered. The DECIPHER project is attempting to close that gap.

Bringing together expertise from materials science, microfluidics, bioassay development, clinical medicine and artificial intelligence, the European research initiative is developing a radically simplified diagnostic platform designed to compress the entire laboratory workflow into a single device. If successful, it could fundamentally change how infectious diseases are detected and managed in decentralised healthcare settings.

Moving diagnostics
At the centre of the project is a deceptively simple idea: what if the entire process of sample collection, preparation, analysis and result generation could happen inside a single disposable patch?

“The idea behind DECIPHER is to address a gap that still exists in outbreak response and point-of-care diagnostics,” says project coordinator Karen Leirs, group lead in microfluidics and bioassays at KU Leuven leading the project’s technology development. “We want truly quantitative and rapid detection from sample to result at the point of care – without needing a laboratory or complex equipment.”

In principle, this type of technology could detect many different pathogens, but the DECIPHER consortium has chosen to focus on the Ebola virus disease and Lassa fever as model systems. Both are high-consequence viral infections that continue to cause outbreaks in parts of West and Central Africa and present major diagnostic challenges.

“Early symptoms are easily confused with other viral, bacterial or parasitic illnesses such as malaria or typhoid,” explains Karifa Kourouma, PhD researcher and clinical research Lead at the Centre National de Formation et de Recherche en Santé Rurale de Maferinyah, and coordinator of DECIPHER activities in Guinea. “As a result, cases are often missed or detected too late, so having a device available directly in decentralised health posts and centres would allow healthcare workers to obtain results immediately. For us in Guinea and other parts of West Africa, this would be a real game-changer.”

Bringing testing closer to the point of care is therefore critical, shifting detection out of the laboratory and into frontline settings, enabling faster decisions and earlier intervention. DECIPHER, however, wants to go further and deliver more than a rapid yes-or-no result. The project aims to embed deeper clinical insight within the test itself.

“Our goal is not merely to produce a rapid test, but something more powerful,” says Leirs. “We are embedding a quantitative diagnostic tool into the patch, which will be capable of estimating viral load directly at the point of care.”

This distinction is important. While field-ready rapid tests are hugely important, a simple positive or negative result, offers limited insight into how advanced an infection is or how urgently intervention is required. Being able to estimate viral load provides a far more nuanced picture. Higher viral loads are often associated with increased infectiousness and more severe disease, allowing clinicians to make faster, more informed decisions about isolation, treatment and patient management. In outbreak settings, this can directly influence how transmission is controlled. “If you can identify cases earlier and understand their level of infection, you can respond much more effectively,” explains Kourouma. “That changes how you manage patients, but also how you protect others.”

At a population level, quantitative data also strengthen surveillance. Rather than simply tracking case numbers, health systems can begin to understand how an outbreak is evolving – where it is intensifying, where it is being contained and how interventions are shaping its trajectory.

Diagnostic workflow
Achieving this level of quantitative insight outside a laboratory environment, however, has proven extremely difficult. Traditional molecular diagnostics rely on tightly controlled laboratory conditions. Samples must be carefully measured, processed and purified before amplification and detection steps can occur.

“Determining viral load accurately requires precise control of the starting sample,” Leirs explains. “You need to meter the sample very carefully, extract the RNA and work with calibrated standards under controlled conditions. In a laboratory that is straightforward, but outside the lab, it becomes much more difficult to maintain that level of precision.”

DECIPHER’s answer is to redesign the diagnostic workflow from the ground up. The device takes the form of a small patch equipped with hollow microneedles. When placed on the skin, the microneedles collect a tiny capillary blood sample painlessly from the upper layers of the skin.

“We are responsible for developing the microneedle arrays for minimally invasive blood sampling and integrating them with the iSIMPLE chip for testing,” explains Dr. Burak Ozdoganlar, DECIPHER partner and Ver Planck Endowed Chair Professor of Engineering at Carnegie Mellon University in Pittsburgh, US. “The aim is to make sampling as simple and as safe as possible — removing the need for traditional blood draws, reducing handling steps, ensuring sample robustness, and minimising the risk of exposure. That is particularly important for high-consequence infections.”

Once collected, the sample is transferred directly into the iSIMPLE chip – the core of the system, where the entire diagnostic process takes place. “Self-powered microfluidic channels draw the sample through a sequence of miniature processing steps,” Leirs explains: “Plasma is separated from red blood cells, reagents are mixed automatically and the viral genetic material is amplified using an isothermal reaction that avoids the temperature cycling required in PCR systems.

“The moment the sample enters the chip, the entire process runs automatically,” she continues. “There is no manual sample handling and no laboratory equipment.”

The system ultimately converts the viral signal into something familiar: a glucose measurement. By coupling the biochemical reaction to a repurposed glucose meter – a device already widely used around the world – the platform can produce a numerical readout representing the amount of viral RNA present in the sample.

In effect, the technology transforms a ubiquitous medical device into a miniature molecular laboratory.

Beyond testing
While the patch forms the technological core of DECIPHER, the project’s ambition extends far beyond the diagnostic device alone. The consortium is also developing a data-driven epidemic intelligence platform designed to interpret test results within a broader public health context. “Testing as close as possible to patients is extremely important for contagious diseases,” says Caroline Van Cauwelaert, CEO of Epcon, leading the development of AI-based disease prediction models to support deployment of the patches. “But the real value lies in what we can do with that data, not only understanding outbreaks, but predicting how Ebola and Lassa fever will evolve geographically over time.”

Using environmental data, demographic indicators, mobility patterns and healthcare access information, the project’s models aim to identify where transmission is emerging, and forecast how it is likely to spread across regions over time. “By combining real-time diagnostic data with predictive modelling, the DECIPHER platform can support more informed decision-making,” adds Van Cauwelaert. “It enables health authorities to move from reactive outbreak response to proactive management, forecasting where diseases will spread next and acting before transmission accelerates.

Rather than producing opaque predictions, the platform emphasises transparency. Risk maps and data layers can be visualised through a geo-portal, allowing public health experts to understand the factors driving potential outbreak hotspots. “We want decision-makers to understand the reasoning behind the models,” Van Cauwelaert explains. “The goal is to support their expertise, not replace it.”

Combined with rapid point-of-care testing, this creates a more responsive system — enabling health authorities to deploy diagnostics strategically, directing tests and medical teams to the areas where outbreaks are predicted to emerge or intensify.

Outbreak response
The need for such approaches has become increasingly evident in recent years.Globalisation, climate change and population mobility are expanding the geographic range of many infectious diseases. At the same time, healthcare systems are moving towards more decentralised models of care, with greater emphasis on community-level diagnostics.

The COVID-19 pandemic exposed the fragility of laboratory-centred testing infrastructures during large outbreaks. “Laboratories can become overwhelmed with samples,” says Jeroen Lammertyn, Professor at KU Leuven and coordinator of the DECIPHER project. “Point-of-care screening tools can help identify high-risk patients quickly before confirmatory testing is performed.”

For diseases such as Ebola, the implications could be profound. “Early diagnosis allows infected individuals to be isolated more quickly, reduces transmission risk and enables supportive treatment to begin sooner,” adds Lammertyn. “It also improves biosafety by reducing the need for manual blood handling.”

Leirs explains why this matters: “In many outbreak situations, hours matter,” she says. “If we can move reliable diagnostics directly to the frontline, that changes how quickly health systems can respond.”

The patch could also ease the burden on laboratories. In many hospitals, patients suspected of viral haemorrhagic fevers must be retested multiple times during treatment. “A decentralised diagnostic tool could reduce laboratory workload and testing costs,” notes Kourouma.

Real-world deployment
DECIPHER is currently progressing through the integration phase of the project, where the various components of the platform are being combined into a single functional system. “Many of the individual processes have already been demonstrated in the laboratory,” says Lammertyn. “The next step is integrating them onto the chip and ensuring the system is robust.”

Future stages will include larger-scale validation and eventual clinical testing. The consortium is also working closely with industrial partners to ensure that the device can be manufactured at scale.

Unlike many academic microfluidic systems, which remain confined to laboratory prototypes, the project’s materials and fabrication methods have been selected specifically for compatibility with industrial roll-to-roll manufacturing processes. “From the beginning, we have been thinking about how this can be produced at scale,” says Leirs. “The materials and processes we are using are chosen to be compatible with existing manufacturing technologies, so this is not something that remains in the lab.”

The goal is to move beyond proof-of-concept devices toward something that could realistically be produced and distributed worldwide. “That translation to real-world use is essential,” adds Lammertyn. “We are not just developing a technology – we are working towards a system that can be deployed where it is needed, at the scale required during an outbreak.”

Europe’s preparedness
The project also reflects a broader strategic ambition within Europe to strengthen technological sovereignty in health diagnostics. During the COVID-19 pandemic, global supply chain disruptions exposed Europe’s dependence on external manufacturing for key diagnostic components. By developing new materials platforms and scalable microfabrication technologies within European research and industrial ecosystems, DECIPHER contributes to rebuilding domestic capabilities in advanced in-vitro diagnostics.

At the same time, the project’s international collaborations highlight the importance of global partnerships in outbreak preparedness. “We learn a great deal from our partners in Africa,” says Van Cauwelaert. “They have extensive experience managing outbreaks and provide essential insights into real-world implementation.”

Such collaborations help ensure that the technology is designed for the environments where it will ultimately be used and not only in terms of performance, but also scalability, usability and real-world deployment. This forward-looking approach also underpins the project’s longer-term vision as a platform for the future.

A platform for the future
Although the project currently focuses on Ebola and Lassa fever, the underlying technology is designed to be adaptable. “This is fundamentally a platform,” explains Ozdoganlar. “Once the system is validated, it could be adapted for measuring a range of biomarkers, including pathogens for other infectious diseases.”

That flexibility could prove crucial in a world where emerging pathogens continue to pose unpredictable threats. For the researchers involved, the ultimate measure of success will be whether the technology reaches the communities that need it most. “If this device can help prevent deaths during future outbreaks,” says Lammertyn, “that would be the greatest impact we could hope for.”

More broadly, the project aims to develop something larger than a single diagnostic product: a blueprint for how advanced materials science, microfluidic engineering, digital modelling and clinical expertise can be combined to build the next generation of decentralised healthcare technologies. In an era when the next pandemic could emerge at any time, that capability may prove essential.