Mobile PCR
the use of portable PCR or qPCR instruments, simplified protocols and connected components to perform molecular tests near the point of care or directly in the field.

qPCR / real-time PCR
a technique for the amplification and quantitative or semi-quantitative detection of genetic sequences, widely used in molecular diagnostics to identify pathogens and specific targets.

POCT (Point-of-Care Testing)
testing performed near the patient or the place where the clinical decision is made, with the aim of reducing the time between sampling, result and action.

Turnaround Time (TAT)
the total time between sample collection, analysis, validation and result availability. In infectious disease emergencies, it is one of the most relevant indicators for assessing the operational impact of the test.

Mobile laboratory
a mobile or rapidly deployable diagnostic unit designed to operate in emergency settings, remote areas, local outbreaks or temporary facilities.

Hyris System™
a proprietary technology platform of the Hyris Division of Helyx Industries S.p.A., comprising hardware, software and reagents for distributed qPCR workflows.

A pandemic does not test only the scientific ability to identify a pathogen. It tests time. How quickly a sample is collected, analysed, validated and turned into a clinical or public health decision can determine the difference between a contained outbreak and transmission that is more difficult to control. This is why diagnostics is not an ancillary element of preparedness: it is an infrastructural component of the response.

The World Health Assembly has recognised that diagnostic services are vital for prevention, diagnosis, case management, monitoring, treatment and surveillance, and that national and subnational diagnostic capacity is essential for controlling outbreaks and pandemics [1]. In a complementary way, the ECDC emphasises that the rapid diagnosis of infectious diseases is relevant not only to the timely treatment of patients, but also to surveillance, outbreak detection and the control of the spread of infections at national and international level [2].

The COVID-19 pandemic exposed a structural limitation: centralised laboratories remain essential, but at peak times they can become bottlenecks if they have to meet the entire diagnostic demand on their own. Mobile PCR emerged from this need: to bring the quality of molecular diagnostics closer to the point where the data is needed. This does not mean turning every clinic into a fully equipped laboratory, or replacing reference centres. It means creating distributed diagnostic capacity that is governed, qualified for the context of use and connected to the central system.

For Helyx Industries S.p.A., this topic falls primarily within the remit of the Hyris Division: distributed qPCR, the Hyris System™ platform, bCUBE™, bAPP™, reagents and connected workflows [15]. Clinical IVD applications and diagnostic panels instead fall within Vytro's remit, while Mytho covers the NGS and bioinformatics layer, which becomes relevant when a pandemic response requires sequencing, genomic surveillance or analysis beyond PCR [14][16][17]. This is an important distinction: in pandemic response, speed, validation and depth of information are not one and the same. They are different layers of the same industrial architecture.

Mobile PCR is not simply a small instrument. It is a combination of requirements: instrument portability, workflow robustness, controlled sample management, reagents compatible with more challenging logistical conditions, management software and assisted result interpretation, data traceability and connection to a supervisory system. Without these elements, portability risks remaining a physical feature rather than a true operational capability.

The literature on point-of-care molecular diagnostics shows that miniaturisation can reduce the distance between sampling and result, but only when it is accompanied by automation, quality control, training and procedures suitable for operators who are not necessarily specialists [5][6]. This is the difference between a portable instrument and a deployable diagnostic system.

In the case of Helyx Industries S.p.A., the Hyris Division operates precisely at this level: not hardware alone, but a platform. A study of Hyris bCUBE™ for rapid molecular testing of saliva described the platform as a POCT innovation undergoing operational validation [7]. An earlier study evaluated the application of a portable instrument for the rapid detection of SARS-CoV-2 in different settings [8]. This evidence is specific to SARS-CoV-2 and does not justify inappropriate generalisations to every pathogen or scenario; it nevertheless confirms an industrially relevant point: distributed qPCR can become a tangible component of diagnostic models closer to the territory when assays, workflows and contexts of use are adequately defined.

The value of mobile PCR therefore lies in the combination of three elements. The first is proximity: the test can be performed near the patient, the affected community or the point of healthcare access. The second is time: reducing TAT can make the result available within the same decision-making window. The third is data: a decentralised result, if traced and governed, can feed clinical and surveillance flows without remaining isolated in the field.

During COVID-19, rapid antigen tests and isothermal techniques such as LAMP expanded diagnostic capacity outside laboratories. This experience also showed, however, that not all tests answer the same question. Antigen tests can be very useful for rapid screening and in high-prevalence settings, but the literature on rapid tests for SARS-CoV-2 documents generally lower sensitivity than molecular tests, with performance affected by viral load, symptoms, timing and method of use [9].

Isothermal techniques have a different profile: they are molecular, rapid and can reduce instrument complexity compared with conventional PCR. Even in this case, however, the choice should not be presented as a universal substitution. PCR, LAMP and antigen tests are different tools within a broader diagnostic strategy. The right question is not ‘which technology wins’, but which combination delivers the best balance between sensitivity, speed, cost, scalability, availability and clinical decision-making.

Mobile PCR occupies this space as an established molecular technology, particularly useful when nucleic acid detection, multiplexing capability, workflow control and integration with quality systems are needed. Its usefulness is greatest when sample transport time or the central laboratory's workload risks delaying a result that, technically, could be produced much more quickly.

In other words, mobile PCR should not be burdened with an unrealistic promise. It is not the sole answer to every pandemic scenario. It is a technology of high operational value when the emergency requires molecular data close to the point of decision, without compromising result traceability and quality.

The first area of value is hospital triage. In emergency departments and wards under intense pressure, knowing quickly whether a patient is positive for a respiratory pathogen can change isolation measures, the admission pathway, resource use and management of nosocomial risk. COV-19POC, a prospective, interventional, non-randomised, controlled study, showed that introducing point-of-care molecular testing for suspected COVID-19 in hospital reduced the median time to result from 21.3 hours to 1.7 hours, with effects on patient placement and isolation management [3].

The second area is the community. During a health crisis, not all patients can or should converge on large diagnostic hubs. A decentralised testing model can improve access for remote communities, vulnerable populations or geographically challenging settings. The Australian experience in remote Aboriginal communities, described in The Lancet Infectious Diseases, showed how a decentralised COVID-19 testing model could help reduce inequalities in access and response times in underserved areas [4]. More generally, the literature on sample-to-result molecular platforms in resource-limited settings highlights that proximity, operational simplicity and integration with the healthcare system are decisive when infrastructure, transport and laboratory capacity are real constraints [6].

The third area is mobile response in the strict sense: temporary units, mobile clinics, local facilities, emergency teams, airport health facilities, disaster-affected areas or localised outbreaks. Experiences with mobile laboratories in high-risk outbreaks such as Ebola have already shown the value of rapidly deployable, modular and robust systems capable of bringing molecular diagnostic capacity close to the point of need [10].

The fourth area is continuity of surveillance. A field test is useful for the individual patient, but it can become more useful to the system if the data does not remain local. In a connected model, the result can be integrated into dashboards, laboratory flows, surveillance systems and escalation procedures. Here, however, the technology must be governed: standards, data quality, cybersecurity, privacy and interoperability are not optional, but prerequisites.

An effective mobile workflow must be designed as a chain: sampling, preparation, amplification, quality control, validation, data transmission and action. Each link introduces specific risks. A poorly collected sample can produce a weak result. A test performed outside the procedure can compromise comparability. Data that is not integrated can remain invisible to the system. A connected platform without adequate cybersecurity can create new risks.

For this reason, mobile PCR must be designed as a governed capability, not as an isolated device. Distributed platforms must include standardised protocols, internal controls, batch management, operator logs, the possibility of remote supervision and clear pathways for confirmation or escalation to central laboratories. In its mapping of POCT devices, the ECDC emphasises that the availability of tests near the patient can support clinical and public health functions, while also highlighting the importance of quality, diagnostic confirmation and integration with existing systems [2].

The issue becomes even more relevant when mobile diagnostics is connected. Within the Hyris portfolio, bAPP™ represents the software component of the distributed platform: device management, workflow traceability and data availability in a digital environment [18]. This should not be described as ‘data monetisation’ or as unsupervised automation of clinical decisions. A different formulation is more accurate: diagnostic data governance, operational supervision and support for aggregated epidemiological interpretation, within workflows defined and validated for the specific intended use.

Cybersecurity becomes a structural element here. The FDA guidance on medical device cybersecurity, updated in 2026, stresses the importance of considering design, vulnerability management, documentation and resilience throughout the device lifecycle [11]. For a mobile PCR network, this means that robustness is not only thermal or mechanical. It is also digital.

Within the new structure of Helyx Industries S.p.A., mobile PCR is primarily a Hyris topic. Hyris covers the distributed qPCR platform: hardware, software, reagents and workflows. It is the division most directly connected to the question, ‘how do I bring reliable molecular capacity outside the central laboratory?’ [14][15].

Vytro comes into play where the platform meets the clinical IVD domain: panels, kits, validation, medical applications and deep multiplexing, where applicable and depending on the intended use. In a pandemic context, Vytro's value is not to ‘provide mobility’, but to help bring clinical, documentary and regulatory robustness to diagnostic applications that can be performed within hospital or community networks [16].

Mytho completes the architecture at the beyond-PCR layer. A modern pandemic response does not end with detecting positive and negative cases. It may also require genomic surveillance, variant identification, cluster analysis and sequencing. This is Mytho's remit: not mobile PCR, but custom NGS, bioinformatics pipelines and support for deeper levels of molecular characterisation [17].

This distinction avoids a common error in biotech communications: conflating different technologies into a single indistinct promise. An effective pandemic response does not arise from one technology alone, but from an architecture: distributed qPCR for proximity, IVD and multiplex PCR for clinical applications, and NGS for depth of information.

Mobile PCR is not easy to scale. The first limitation is pre-analytical: sampling, storage, biosafety and sample preparation remain critical stages. Even the best instrument cannot compensate for a poorly designed workflow.

The second limitation is organisational. Who performs the test? Who validates the result? When is central confirmation needed? What data enters the electronic health record or surveillance system? Who is responsible for maintenance? Without clear answers, decentralisation can create fragmentation rather than resilience.

The third limitation is regulatory. In Europe, in vitro diagnostic medical devices are subject to the IVDR framework, which requires correct classification, technical documentation, post-market surveillance and lifecycle management [12]. For IVDs, performance evaluation must distinguish between scientific validity, analytical performance and, where applicable, clinical performance [13]. If the software component contributes to managing or interpreting the result, specific requirements for software, data quality and security also come into play.

The fourth limitation concerns training. The promise of mobile PCR is not that ‘anyone can perform any test anywhere’. It is that ‘appropriately trained operators can perform standardised workflows in settings closer to the patient, under the governance of the laboratory and the healthcare system’. This difference is essential for maintaining credibility.

Diagnostic infrastructure is not built during a crisis. It is designed beforehand. The lesson from recent pandemics is that testing capacity must be modular, redundant and rapidly scalable. A system composed only of large central hubs is efficient under ordinary conditions, but can become fragile when demand rises suddenly or when some areas remain logistically isolated.

Mobile PCR makes it possible to think of preparedness as a network. Some nodes remain central and highly specialised. Others are peripheral, mobile or temporary. Data must be able to flow into a common system. Protocols must be consistent. Technologies must be interoperable. Supervision must remain clear.

This is also why the Helyx Industries S.p.A. model can be described credibly: not as a generic promise of a ‘laboratory anywhere’, but as an industrial platform capable of connecting different layers of molecular diagnostics while keeping their respective remits clear. Hyris brings distributed qPCR into the community. Vytro covers clinical and IVD applications. Mytho opens up the NGS and bioinformatics layer. Together, the three divisions describe a broader value chain: from rapid detection to advanced characterisation [14][15][16][17].

Mobile PCR is one of the most tangible responses to the fragility exposed during pandemic crises: diagnostic time depends not only on the analytical technology, but also on where the test is performed and how the data is integrated into the healthcare system.

Its main value is not to replace the central laboratory. It is to extend its capacity, reducing logistical delays, creating diagnostic nodes closer to the point of need and making clinical and public health decisions more timely. The available evidence shows that molecular point-of-care testing can substantially reduce turnaround time and improve pathway management in high-pressure settings [3]. Experiences in remote areas also confirm that diagnostic proximity can contribute to equity of access [4]. Experiences with mobile laboratories in high-risk outbreaks, meanwhile, demonstrate the value of rapid deployment and modularity [10].

For Helyx Industries S.p.A., this topic is strategic because it fits naturally within the One Group - Three Divisions structure. Hyris represents the distributed qPCR dimension; Vytro brings the clinical and IVD domain; Mytho covers genomic and bioinformatics depth. In a future health emergency, having a rapid test will not be enough. A molecular network will be needed that can produce reliable, proximate, traceable and interpretable data within validated and governed workflows.

Diagnostic preparedness is no longer a question of individual instruments. It is a question of architecture. And mobile PCR can be one of the most tangible building blocks of that architecture.