Distributed diagnostics
A model in which part of the diagnostic capacity is brought closer to the point of care, whilst governance, quality, data and supervision remain coordinated by a central laboratory or facility.

Local node
A peripheral point in the network – for example, a small hospital, A&E department, care home, local clinic or mobile laboratory – equipped with the appropriate equipment, procedures and training.

Central hub
A facility that coordinates protocols, quality, training, process review, management of updates, escalation and confirmation where necessary.

TAT – Turnaround Time
The time elapsing between the request for or collection of a test and the availability of a result that can be used in the clinical or operational pathway.

HL7 FHIR
An HL7 standard for the electronic exchange of health information, useful for integrating diagnostic results with clinical applications and information systems. [6]

Hub & spoke
An organisational model in which a central hub supports multiple peripheral sites, reducing the need to replicate all laboratory expertise and infrastructure at every location.

Intended use and IVD scope
When a test or panel enters a regulated clinical context, the reportable value must remain consistent with the intended use, analytical performance, clinical performance and applicable requirements.[16]

Molecular diagnostics is undergoing a structural transformation: alongside large, centralised laboratories, distributed models are emerging, in which some of the tests are carried out close to the patient and linked to digital monitoring systems. This is not a matter of pitting central laboratories against point-of-care testing, but of redesigning the workflow: the sample remains closer to the collection site, whilst the diagnostic data is transmitted via the network and fed more rapidly into clinical or organisational processes.[1]

This issue is particularly relevant for small hospitals, outlying areas, local healthcare facilities, care homes and local laboratory networks. In these contexts, the time lost in sample logistics can account for a significant proportion of the diagnostic pathway. The literature on point-of-care laboratories in microbiology shows that bringing the test closer to the patient can reduce turnaround time and improve operational management, provided that the model is underpinned by adequate quality, training and governance. [2]

Within Helyx Industries S.p.A., this issue falls primarily within the Hyris Division, which specialises in distributed qPCR and the Hyris System™ platform. Where the network is applied to clinical tests and IVD panels, value is also delivered by the Vytro Division, which represents the group’s clinical and medical remit. This distinction is important: Hyris enables the distributed technological infrastructure; Vytro oversees the clinical diagnostic application when the workflow enters an IVD context and must be supported by intended use, evidence and consistent regulatory requirements.[13][14][15][16]

The centralised laboratory remains indispensable: it brings together expertise, quality controls, high test volumes and highly complex equipment. The limitation becomes apparent when every sample – even urgent ones or those from distant locations – must pass through the same logistical bottleneck. A distributed network is created to separate what must remain centralised from what can be brought closer to the point of care without compromising quality control.

In a replicable model, the central laboratory becomes a hub for quality and supervision. It defines protocols, training, performance monitoring, validation criteria, escalation procedures and confirmatory testing where necessary. Peripheral nodes carry out selected tests that are standardised and consistent with locally available expertise. This approach can reduce the transport of samples for the most time-sensitive analyses and allow the central laboratory to focus on specialist activities. [2]

Clinical evidence suggests that operational value is realised most effectively when decentralisation is integrated into the decision-making process. In the COV-19POC trial, the introduction of point-of-care molecular testing for suspected COVID-19 in hospital reduced the median reporting time from 21.3 hours to 1.7 hours, with implications for patient management and isolation. [3] This finding should not be interpreted as a universal promise, nor as a result that can automatically be applied to other pathogens, platforms or settings. It does, however, demonstrate the organisational principle: rapid testing delivers value when the result is received within the timeframe in which it can still inform a decision.

A regional distributed diagnostics network can be described as a three-tier system: local nodes, a central hub and a digital layer. The local nodes house the qPCR equipment and operational procedures; the central hub governs quality, protocols and supervision; the digital layer connects the system, providing access to results, traceability and performance data. Within the Hyris framework, the concept of a local node translates into compact, connected qPCR instruments. Published studies on the Hyris system have evaluated the use of bCUBE™ in specific contexts of rapid molecular testing for SARS-CoV-2, supporting the operational rationale for decentralised applications.[4] [5]

This evidence should not be automatically extended to every test panel or context of use, but it demonstrates how analytical capacity can be distributed within selected, controlled and validated workflows. The central hub retains methodological control. This includes test selection, sampling procedures, internal controls, validation criteria, operator management, monitoring of indicators and management of non-conformities. The network should not be interpreted as a collection of isolated devices, but as an extended laboratory: physically distributed, yet unified by operational rules and documented quality. The digital layer is what makes the model scalable. Without IT management, a network of devices risks leading to fragmentation; with a coherent software layer, however, results can be collected, made traceable, integrated into clinical systems and used to monitor performance, demand and regional anomalies. The WHO’s digital health strategy emphasises that digital health initiatives must integrate financial, organisational, human and technological resources, rather than being limited to the introduction of tools.[7]

The crux of a diagnostic network is not merely to produce a result, but to ensure it reaches the correct information destination. If the result remains confined to a separate application or requires manual re-entry, the operational benefit is reduced. For this reason, interoperability with LIS, LIMS, electronic health records and regional systems should be a project requirement, not an optional feature.

FHIR, published by HL7, is a standard for the electronic exchange of health information and was developed to support interoperability between clinical applications, diagnostic data and digital workflows.[6] 

In a distributed network, standards of this kind enable the result from the peripheral node to be treated as part of the clinical information ecosystem, rather than as external data that must be re-entered manually. For healthcare organisations, this changes the nature of the project. The diagnostic network is not merely an investment in devices: it is a process infrastructure. It requires IT integration, the definition of roles, data accountability, cybersecurity, access management and operational continuity. In the absence of these elements, decentralisation can increase complexity; with them in place, it can become a lever for measurable efficiency.

The initial benefits become apparent in contexts where distance from the central laboratory is a greater factor: small hospitals, local health centres, residential care homes, outlying clinics, islands, mountainous areas and consortia of laboratories. In these scenarios, it does not always make sense to duplicate complex infrastructure; it makes more sense to create a network of selected nodes, with targeted testing and central supervision.

Internationally published case studies show that network design is crucial. In Lesotho, the strategic placement of point-of-care tests for the early diagnosis of paediatric HIV utilised a hub-and-spoke model to serve a wider number of facilities without distributing equipment everywhere: 29 testing sites were selected to potentially increase access to 189 facilities through local referral networks. [8]

This principle is relevant beyond HIV, but not as an automatic transfer of the approach: diagnostic capacity must be located where it maximises access, sustainability and operational impact within the specific context.

A second useful example comes from remote and underserved communities. During the COVID-19 response, decentralised models of point-of-care testing were proposed and implemented to reduce inequalities in access to diagnosis, particularly where logistics to central laboratories were slow or complex.[9] In the European and hospital settings, the same principle can guide networks for small hospitals, care homes or local healthcare centres that need to make rapid decisions without always relying on sample transport.

Communal settings, such as care homes and residential care facilities, also represent a significant area of application. Recent studies on the implementation of point-of-care molecular testing for respiratory viruses in communal settings indicate that the model can shorten turnaround times and support more timely outbreak management when integrated with infection prevention procedures and clear clinical responsibilities.[10]

The replicability of the model depends on its measurability. A regional network should not be assessed solely on the basis of the number of devices installed, but on the operational value it generates. The most useful KPIs are few in number, clear and easily understood by laboratories, healthcare management and public decision-makers.

Average TAT and TAT by percentile: these indicate how quickly the result is received compared with the previous process. It is important to measure not only the average, but also the proportion of results available within clinically useful timeframes, for example within two hours or during the same consultation.[3]

Node utilisation rate: this measures whether distributed capacity is actually being used or remains underutilised. A healthy network does not require all nodes to operate at the same volume, but must demonstrate a distribution consistent with demand, urgency and territorial coverage.

Rate of invalid or repeat tests: this is a quality indicator. If it rises, it may signal problems with training, sampling, maintenance, reagents, local procedures or integration of the pre-analytical workflow.

Escalation or confirmation rate: this measures how many tests require central review, specialist confirmation or referral to a reference laboratory. It is a useful indicator for preventing the network from operating autonomously beyond its remit.

Potentially avoidable isolation time and potentially reducible days of hospitalisation: these are clinical and organisational indicators that should be used with caution, as they depend on the care pathway and not solely on the technology. In rapid hospital-based molecular testing, the literature shows that reducing the TAT can influence patient management and isolation, but the impact must be measured within the actual context of implementation. [3]

The cost of the care pathway, not just the cost of the test: the unit cost of a decentralised test may be higher than the reagent cost of a centralised test, but a fair comparison must include transport, waiting times, isolation, staffing, repeat tests, escalation and treatment decisions. A review of cost-effectiveness models for point-of-care molecular testing for paediatric HIV compared with centralised testing shows that the economic value depends on the overall pathway and the context of implementation.[11]

When discussing decentralised diagnostics, there is a temptation to think that simply installing devices at the point of care is sufficient. In reality, technology is just one component. Before scaling up, clear guidelines are needed on which tests to decentralise, which to leave to the central laboratory, which staff to involve, what training is required, and what thresholds to use for escalation and confirmation.

The literature on point-of-care testing in microbiology emphasises precisely this point: the benefits of POCT do not automatically stem from the availability of the device, but from its integration into clinical pathways, quality assurance and operational decision-making.[12] A replicable network must therefore include at least four levels of governance: analytical quality, pre-analytical quality, IT management and clinical accountability for the result.

When the model is applied within an IVD context, governance must also include intended use, analytical performance, clinical performance, risk management, traceability and the continuous updating of evidence. MDCG Guidance 2022-2 notes that the performance evaluation of an IVD is a continuous process and encompasses scientific validity, analytical performance and clinical performance, where applicable. [16]

A possible implementation can follow three phases. The first is a mapping of workflows: which samples are transported, within what timeframes, for which conditions, and with what clinical and organisational impacts. The second is a pilot study involving a few high-value nodes: a peripheral A&E department, a care home, a small hospital or a local outpatient clinic with a clear demand. The third is controlled scaling: adding nodes only when operational data justify the expansion, with centralised training and supervision.

This approach avoids two opposing pitfalls: centralising everything out of habit, or decentralising everything out of enthusiasm for technology. The effective model is selective: it distributes the tests that gain value from proximity and leaves at the centre those that require high complexity, high volumes or specialist confirmation.

Within the One Group – Three Divisions model, this article focuses primarily on Hyris.

The focus is on the distributed qPCR network: portable instruments, software management, standardisation of workflows and the ability to extend molecular diagnostics beyond the central laboratory, within controlled and traceable frameworks. Hyris therefore represents the infrastructure layer of the model.[13][14]

Vytro comes into play when the distributed network is applied to clinical and IVD contexts: hospitals, laboratories, diagnostic panels, deep multiplexing and regulated pathways. From this perspective, the network is not merely a collection of instruments, but an operational channel through which clinically relevant molecular tests can be integrated into decision-making pathways, where the specific intended use and performance evidence permit.[15] [16]

Mytho falls outside the scope of this article, as the focus here is not on NGS but on distributed qPCR. However, from a broader perspective, the separation between PCR infrastructure, IVD applications and NGS services allows Helyx Industries S.p.A. to be viewed as an integrated industrial group: each division has a distinct role, and the strategic value stems from the ability to orchestrate different areas of expertise across the molecular biology value chain without blurring their respective boundaries.

A regional network of distributed diagnostics can only be replicated if it is designed as an infrastructure, rather than simply as a distribution of instruments. The central laboratory remains the hub; the peripheral nodes become operational extensions; the digital layer links data, quality and decision-making.

The most obvious benefit may be a reduction in turnaround time. The deeper value, however, is organisational: the network can bring molecular diagnostics closer to the patient, make data more interpretable and the system more resilient. In small hospitals, care homes, remote areas and consortium networks, this can transform testing from a logistical exercise into a more immediate component of the clinical pathway, provided the network is designed around clear guidelines, responsibilities and KPIs.

The key is not to trivialise the model. Governance, interoperability, training, KPIs, quality and a clear distinction between what to decentralise and what to keep centralised are all required. The available evidence confirms that molecular POCT can improve turnaround times and access in selected settings, but the outcome depends on the design of the network and its integration into real-world workflows.[1][12]

For Helyx Industries S.p.A., this issue reinforces the role of the Hyris Division as an enabler of distributed molecular diagnostics and of the Vytro Division as the clinical framework when the network hosts IVD tests and panels. The regional network is therefore not a futuristic concept: it is a concrete industrial model where technology, organisation, data and accountability are designed together to bring the laboratory closer to the point of care without compromising on quality or control.