In health emergencies – from sudden epidemics to natural disasters – rapid diagnostic intervention is critical. Timely diagnosis can make the difference between containing an outbreak in its early stages and allowing it to develop into an uncontrollable epidemic.

However, it is precisely in the most critical situations that access to traditional diagnostic laboratories is often limited or non-existent. For example, it is estimated that around 43% of the world's population (over 3 billion people) live more than an hour's walk from a basic healthcare facility, with obvious difficulties in accessing essential laboratory tests in a timely manner [6].

During the COVID-19 pandemic, this fragility became clear: dependence on a few centralised diagnostic centres resulted in reporting times of 48–72 hours for molecular swabs, allowing many asymptomatic positive cases to infect others before even knowing the test results. In low-resource countries, the situation is even more extreme: the lack of equipped laboratories in remote areas means that dangerous pathogens can spread silently, undetected until the epidemic is already underway. Fortunately, recent years have seen the emergence of innovative diagnostic solutions designed to bring the laboratory directly to the emergency site. As summarised by an expert from the Foundation for Innovative New Diagnostics (FIND), 'it is no longer the patient who has to go to the clinic, but the test that reaches the patient' [3]. This paradigm shift is made possible by portable molecular biology devices – in particular miniaturised real-time PCR systems – combined with room-temperature stable reagent kits and digital cloud platforms for immediate data collection and analysis. Helyx Industries, through its HYRIS division, with its proprietary Hyris System™ platform that includes the bCUBE™ portable qPCR thermocycler and bAPP™ cloud software, embodies this trend: it integrates hardware, chemistry and software to perform advanced genetic testing wherever it is needed, quickly and reliably. Before examining in detail the impact of such solutions on crisis management, it is useful to frame the clinical-operational context in which they are used.

Under normal conditions, a diagnostic laboratory test follows a relatively standard procedure: sample collection from the patient, transport to the laboratory, analysis by specialised personnel, reporting and communication of the result to the requesting doctor.

This process involves a total Turn-Around Time (TAT) that can range from a few hours to several days, depending on the distance and workload of the laboratory. In health emergencies, a prolonged TAT becomes unsustainable. Any delay in diagnosis leads to delays in clinical and public health decisions (case isolation, early treatment, contact tracing), with a real risk of losing control of the epidemic. As the World Health Organisation points out, timely diagnostic services are vital for surveillance, case management and control of epidemic outbreaks [1].

In an epidemic, time is life [5]: identifying an infection as early as possible means that measures can be taken immediately to contain it. Unfortunately, operating conditions in emergencies are often prohibitive. Just think of a remote village affected by Ebola or a refugee camp in the midst of a conflict: local health infrastructure may be minimal and lack laboratories, communication channels may be disrupted, and there may be insufficient specialised personnel. In these circumstances, the classic model of centralised diagnosis shows all its limitations. Biological samples collected in the field (swabs, blood, biopsies, etc.) must be labelled and sent – often over long distances and by makeshift means – to a centralised regional or national laboratory.

Each step adds latency: physical transport takes time, samples may wait in a queue before being analysed, and even after analysis, the report must be returned to operators in the field. This cycle can take days. In a highly transmissible epidemic, waiting even 48–72 hours for a result can mean dozens of preventable new infections.

Decentralised molecular diagnostics aims to bridge this gap by bringing testing directly to the patient, even in the most disadvantaged settings. This requires compact but high-performance devices that can operate without infrastructure, and protocols suitable for non-specialist personnel. In recent years, portable PCR solutions have been developed that offer laboratory-grade sensitivity and accuracy directly in the field [3]. 

Polymerase Chain Reaction (PCR) is a genetic amplification technique that allows small traces of DNA or RNA from a pathogen to be detected by exponentially duplicating them in vitro. In the quantitative real-time variant (qPCR), the process is monitored cycle by cycle, allowing the target genetic material to be quantified as it is amplified and a result to be obtained in less than an hour.

Until recently, real-time PCR was the exclusive preserve of laboratories equipped with bulky bench-top thermocyclers. Today, however, there are portable thermocyclers that are the size of a small box but capable of delivering performance comparable to that of laboratory equipment. The bCUBE™ from Helyx Industries' HYRIS division is an example of this new generation of devices: a compact, battery-powered qPCR unit that can be easily transported in a briefcase and operated wherever needed.

Independent studies have shown that portable PCR systems can provide accurate and reliable results in field settings, with high concordance with hospital reference tests [3]. In practice, this gives first responders advanced diagnostic capabilities that previously required a centralised laboratory.

Alongside hardware, advances in reagent chemistry have been crucial. A PCR machine alone would be of little use if diagnostic kits required conditions incompatible with the field. Traditional PCR mixtures include enzymes and reagents that must be stored cold (-20 °C) to prevent degradation. This requires the so-called cold chain: refrigerators, dry ice, power generators – all things that are difficult to guarantee in a disaster scenario or in a village without electricity.

The solution came in the form of freeze-dried reagents and ambient-stable formulations, which remain effective at room temperature for months. Helyx Industries, through its HYRIS division, rose to this challenge by developing molecular test panels with chemical components that are stable outside the refrigerator, precisely to minimise logistical requirements in the field. "Our goal was to bring the sensitivity of a laboratory directly to the field, in any conditions, while minimising logistical requirements," says Lorenzo Colombo, CTO of Helyx Industries, confirming the design emphasis placed on robustness and operational autonomy.

In addition to portability and the absence of cold chains, modern solutions focus on ease of use and automation. Kits prepared for use in emergencies often include everything needed for analysis (swabs, test tubes pre-filled with lyophilised reagents, positive and negative controls) and simplified protocols. This means that even non-specialist personnel, with brief training, can correctly perform a molecular test in the field. The combination of these technological innovations – compact hardware, stable reagents and user-friendly protocols – allows for on-site laboratory diagnostics in the early stages of an emergency, radically changing the operational flow compared to the past.

Implementing decentralised molecular testing in crisis situations means completely rethinking the diagnostic flow compared to the traditional centralised model. In a classic scenario, as we have seen, the sample travels from the patient to the laboratory, and the result comes back after a long process. With portable PCR, however, it is the laboratory that travels to the patient.

This brings immediate benefits in terms of time and organisation. Imagine a Civil Protection first response unit or a Médecins Sans Frontières team in an area affected by an epidemic: thanks to tools such as bCUBE™, a sample from a suspected patient can be analysed on site, without the need for transport elsewhere. In practice, within about an hour, we go from sample collection to test results, directly on site. The response appears on the mobile application connected to the device and, at the same time – if there is a connection – is uploaded to the centralised cloud platform (if there is no network, the data is temporarily saved locally and synchronised as soon as possible). This portable mini-laboratory eliminates many of the delays associated with the traditional workflow: there is no waiting for transport, no queuing at the laboratory, and no need to send the results back because they are immediately available and shared.

The operational difference is enormous: waiting times are reduced from days to a few tens of minutes, which means that patients can be triaged almost instantly. Several studies have confirmed that drastically reducing reporting times has a significant impact on epidemic control. In the case of COVID-19, for example, rapid testing made it possible to isolate even asymptomatic individuals earlier, reducing further infections and limiting the exposure of healthcare personnel, while a centralised system with a TAT of 2-3 days meant that many unaware infected individuals continued to spread the virus in the community.

In a highly transmissible epidemic, cutting even 24–48 hours from the cycle of identifying positive cases can significantly flatten the infection curve. Data from Ebola emergencies provide another lesson: every day gained in early diagnosis can prevent dozens of new cases and ultimately save lives.

The advantages are also significant in terms of logistics and organisation. No more cold chain: diagnostic kits formulated to be stable at room temperature eliminate the need for coolers and dry ice in shipments. Infrastructure independence: portable devices run on batteries or small generators, so they can be used even without mains electricity. Flexible scalability: instead of relying on a single large laboratory, which can become a bottleneck, multiple portable units can be deployed in parallel at hotspots, performing multiple tests simultaneously in different locations.

This modular approach makes the diagnostic response much more resilient to sudden workloads. In addition, the relatively low initial costs of a portable device and related kits (compared to building and maintaining a complete field laboratory) allow institutions and NGOs to pre-position these resources in at-risk regions, ready for rapid deployment when needed. An analysis conducted by Resolve to Save Lives estimated that investing as little as $5,000 in the very early stages of an outbreak can avoid having to spend tens or hundreds of thousands to control it once it has spread [5].

In other words, acting quickly pays off: proactive investment in on-site diagnostic capabilities pays for itself many times over in terms of avoided costs and lives saved. In summary, thanks to these technological solutions, the new diagnostic workflow during an emergency becomes: sampling → on-site extraction and amplification → immediate transmission of results via the cloud → medical intervention on the patient. All this takes place without relying on fixed infrastructure, as the devices are autonomous and the kits are ready to use.

The added value is twofold: on the one hand, it speeds up the time-to-result for the individual patient (improving their prognosis and care), and on the other, it collects aggregated data in real time on the evolution of the outbreak, which is essential for those who need to coordinate the response at a central level.

Bringing testing where it is needed is only the first step; the second is to enter the diagnostic data obtained in the field into a broader information ecosystem, so as to maximise its usefulness for public health. In a widespread emergency, knowing in real time where and how many positive cases there are is just as vital as diagnosing individual patients. For this reason, solutions such as Hyris System™ from the HYRIS division of Helyx Industries combine the portable PCR device with a dedicated cloud platform (bAPP™) and mobile management applications. The cloud acts as a collector and amplifier of data value: each test result is immediately sent to a secure centralised database, where it can be validated, analysed and made available in dashboard form to authorised operators wherever they are located.

In practice, the national health coordinator can monitor the emergence of new cases in a certain remote area where portable devices are being used almost in real time, without having to wait for paper reports at the end of the day.

Recent history teaches us how important it is to have digital platforms during epidemics. In the past, much critical information – lists of cases, names of contacts, laboratory results – was collected on paper or local spreadsheets, then manually aggregated by decision-makers days later. 

Today, thanks to solutions such as bAPP™ for decentralised diagnostics, case and test data can be collected and viewed in real time, allowing authorities to take immediate action on new outbreaks. In the bAPP™ system, every device in the territory becomes an IoT node in the diagnostic network: as soon as a PCR test is positive, the information (anonymised and in compliance with privacy regulations) appears on the central control panel, geolocated and accompanied by essential details (e.g. type of pathogen detected, quantitative amplification values, etc.).

This allows managers to see where a case is emerging and immediately activate response teams in that area. A key aspect of these cloud platforms is their interoperability with existing information systems. Even during an emergency, the healthcare system does not start from scratch: there are electronic medical records (EMRs), surveillance registries, laboratory information systems (LIMS) and other institutional databases. Effective decentralised diagnostics must communicate with these infrastructures. In the case of bAPP™, for example, APIs are exposed and standard formats are supported to easily integrate with the LIMS of reference laboratories and the EMRs of field hospitals or local facilities. In this way, the result of a test performed in a mobile clinic automatically enters the official information circuit, avoiding double manual data entry and reducing errors.

From an operational point of view, a healthcare professional in the field can use a tablet or smartphone with the bAPP™ app to manage the entire procedure: scan the unique sample code, start the PCR on the bCUBE, and as soon as the run is complete, the result is uploaded to the cloud. If the case is positive, automatic alerts can be triggered: for example, an SMS to the local manager to arrange isolation, or an immediate report to the national epidemic surveillance system. An additional benefit of the cloud connection is the ability to apply advanced analysis to aggregated data.

One example is the quality control module developed by Helyx Industries: it uses machine learning algorithms to ensure high-quality results, bringing field testing performance closer to that of a centralised laboratory, but with the advantage of being able to intervene immediately in the field. Furthermore, by collecting data from dozens or hundreds of deployed devices, platforms such as bAPP™ can generate real-time epidemiological indicators: positivity rates by area, temporal trends in infections, heat maps of outbreaks. This information is invaluable for modulating and targeting the emergency response (e.g. by sending more resources to a province showing a sudden increase in cases).

Of course, all this connectivity must be based on an IT infrastructure that is resilient even in difficult conditions. Redundant cloud servers, end-to-end encryption for the secure transmission of sensitive data, and offline modes must be provided in case the Internet is unavailable (the app must be able to operate and store data locally, synchronising it as soon as the connection is restored). Helyx Industries has placed great emphasis on these aspects, adopting international security standards (ISO 27001/27017/27018) to protect its diagnostic ecosystem. Ultimately, cloud + mobile integration transforms a series of diagnostic devices scattered across the field into a single intelligent network, where each test not only produces a report for the patient, but also feeds into the collective knowledge about the ongoing emergency. This collaborative, data-driven approach greatly amplifies the impact of each individual test: the rapid test saves the patient, the shared data helps save the community.

To truly understand the benefits of decentralised molecular diagnostics, it is useful to examine some scenarios – real or simulated – in which these solutions make (or could make) a difference. Epidemics such as Ebola and COVID-19 have already provided important lessons, but we should also consider situations such as natural disasters or humanitarian crises in conflicts.

Ebola epidemic (West Africa 2014–16 and subsequent developments)

The 2014–2016 Ebola epidemic in West Africa was a watershed moment that highlighted the importance of rapid field diagnostics. The Ebola virus is extremely deadly (up to 90% mortality without treatment) and was spreading in communities without adequate diagnostic laboratories. At the height of the crisis in Guinea, Liberia and Sierra Leone, less than 1 in 5 people were diagnosed within two days of the onset of contagious symptoms – a dramatic delay that allowed the virus to circulate unnoticed. In response, the international community deployed a network of advanced mobile laboratories in the affected countries for the first time. One example was the European EMLab (European Mobile Laboratory) project, which set up modular diagnostic units directly in Ebola treatment centres. The results were remarkable: by bringing PCR close to the hotspots, reporting time dropped to around 4 hours, compared to the 'several days' previously required, allowing for much faster isolation of patients [4]. The first EMLab mobile unit in Guinea alone tested over 5,800 samples in the field between March 2014 and May 2015, revolutionising the response paradigm. The adoption of decentralised molecular testing continued in the following years: in the Ebola epidemics in the Democratic Republic of Congo (DRC) starting in 2018, local authorities – drawing on their experience in 2014 – immediately introduced rapid field testing as the primary method of diagnosis. This ensured immediate results on site and a more agile response. Not surprisingly, an outbreak in the DRC in August 2022 was declared over in just six weeks with only 1-2 confirmed cases [5]. In that event, responders identified and blocked the first infection within three days, preventing the virus from spreading further.

This case clearly demonstrates that early identification means nipping the problem in the bud: the time gained in the early stages of an epidemic translates into lives saved and costs avoided.

Natural disasters and epidemics (e.g. earthquakes and cholera)

Let us now consider an unfortunately realistic scenario: a strong earthquake strikes a densely populated area in a low-income country. Water infrastructure is damaged and, after a few days, cases of watery diarrhoea begin to appear in the camps for displaced persons – signs of a possible cholera outbreak. In a chaotic situation, with roads blocked and hospitals overwhelmed, how can the epidemic agent be quickly identified and contained? Traditional diagnostics (bacterial culture for Vibrio cholerae or PCR in the laboratory) would require samples to be sent to the few facilities still operational, with delays incompatible with the speed at which cholera spreads. A mobile clinic set up by civil protection or the WHO, equipped with a portable PCR device and specific kits, could instead immediately test well water and biological samples from patients on site, confirming the presence of the vibrio within a few hours. This would allow contaminated water sources to be isolated promptly (by distributing disinfectants or closing certain wells) and patients to be treated, stopping the secondary epidemic in its tracks.

A pilot project by the Pan American Health Organisation (PAHO) has demonstrated the effectiveness of a similar integrated approach, called 'labo moto', in epidemic contexts: literally laboratories on two wheels, with nurses travelling by motorbike to collect samples in isolated villages and deliver them quickly to analysis centres, have drastically reduced the time taken to diagnose diseases such as cholera in remote communities in Haiti [2].

Portable PCR would add a further advantage, allowing some of the analyses to be carried out directly in the field rather than in the few centralised laboratories still in operation. A device such as bCUBE™, which can be powered by a small generator or battery, can be deployed in a disaster area within a few hours: in these circumstances, responsiveness is everything, because containing an emerging disease outbreak prevents a health crisis from adding to the ongoing humanitarian crisis. Even in economic terms, spending a few thousand pounds immediately to set up field testing can save hundreds of thousands of pounds needed to control a full-blown epidemic later on – not to mention the lives saved and the socio-economic fallout avoided.

In war zones or refugee camps, infectious diseases can spread rapidly due to poor conditions and limited access to healthcare services.

A concrete example: in some refugee camps in the Middle East, sudden outbreaks of measles, diphtheria or polio have been reported due to the failure to promptly recognise the first case. Here, decentralised diagnostics can be integrated into the activities of humanitarian organisations on the ground. Equipping small field clinics with portable PCR units allows for immediate confirmation of a suspected case: for example, identifying a case of poliovirus in a child with acute flaccid paralysis within a few hours, quickly distinguishing it from other neurological causes. This would immediately trigger emergency immunisation and prophylaxis protocols in the camp, whereas waiting for results from a distant laboratory would waste precious days.

Similarly, in the event of potential bioterrorist attacks, portable instruments such as bCUBE™ could be used by first responders to detect dangerous biological agents (such as Bacillus anthracis, the agent responsible for anthrax) on site without having to send samples to a specialised laboratory: a crucial advantage in protecting rescue workers and guiding countermeasures in real time. In wartime contexts, the operational autonomy provided by compact diagnostic tools can be decisive: when communications and transport are disrupted, every medical team must be able to function almost independently.

Decentralising testing also means decentralising knowledge and skills. Training local staff to use these technologies makes affected communities more resilient and less dependent on external aid as the crisis continues. For example, training some local health workers to perform portable PCR tests in a field hospital ensures that even if international experts are evacuated, basic diagnostic capacity remains in the community. In protracted humanitarian scenarios, this local diagnostic empowerment can make the difference between keeping epidemic diseases under control and letting them explode.

The lessons learned from recent health emergencies converge on one key point: earlier diagnosis, on site, saves lives and resources. The decentralisation of PCR represents a strategic turning point in this regard, combining technological innovation and a rethinking of organisational models. We are facing a real paradigm shift: not just a technical upgrade, but a new way of conceiving the diagnostic response to crises. The laboratory is no longer (just) a static physical location, but becomes a widespread network of intelligent nodes, in which every operator in the field equipped with a portable and connected device can contribute to epidemiological surveillance in real time.

The benefits of this approach resonate on many levels. Clinically, critical patients receive an immediate diagnosis and can immediately receive the necessary treatment or isolation, improving their chances of survival and limiting transmission. Operationally, emergency managers have up-to-the-minute information rather than data that is days old, and can adapt response strategies accordingly (e.g., sending additional teams where cases are increasing, or declaring an emergency over as soon as field tests confirm that there are no new infections). Economically, a relatively small, targeted expenditure at the beginning of an outbreak avoids exponentially higher costs later on – it is like insurance that pays immediate and future dividends. In addition, field testing and early containment mean fewer seriously ill patients need to be hospitalised, reducing the burden on hospitals and intensive care units already stretched thin during disasters.

Of course, large-scale implementation of decentralised PCR requires strategic vision, training and coordination. It is not just a matter of distributing equipment, but of integrating new processes: clear protocols must be defined on who can perform tests and how to act on the results, data quality must be ensured (e.g. by providing for cross-checks, such as confirmation tests on a sub-sample sent to centralised laboratories), and robust reagent supply chains must be maintained even during emergencies. In this regard, companies such as Helyx Industries – with their integrated hardware-software solution and collaborations with academic and institutional bodies – are demonstrating how this model can work in practice, serving as an example of public-private partnership to innovate the response to health crises. In conclusion, the combination of decentralised PCR and emergency management is no longer a futuristic idea, but a rapidly evolving reality. Portable qPCR technologies such as bCUBE™, ambient-stable reagents and intelligent cloud platforms such as bAPP™ are redefining the boundaries of diagnostics: from the privilege of large laboratories to a pocket-sized tool in the hands of first responders.

The message is clear: in future health emergencies, rapid testing in the field will mean controlling the event before it becomes a catastrophe. Preparing by investing in these solutions is equivalent to equipping ourselves with a stronger 'immune system' in terms of public health, capable of responding promptly to any new threat – whether it be an infectious pandemic or an environmental crisis. And when the next crisis strikes (because it is a question of when, not if), we will have learned that speed, accuracy and decentralised diagnostics will be our best allies in protecting human lives.