Molecular diagnostics
A set of technologies that detect DNA, RNA or other molecular markers to identify pathogens, variants, mutations, biomarkers and biological signals relevant to diagnosis, prognosis or treatment decisions.

Distributed qPCR
A model in which real-time PCR tests are performed close to the point of need, using portable or compact instruments, whilst maintaining standardised protocols and data governance.

Deep multiplexing
The ability to detect multiple molecular targets in a single test or panel, particularly valuable in clinical applications where speed, differentiation between pathogens and sample management are critical.

NGS
Next-Generation Sequencing, a mass parallel sequencing technology useful when the clinical question requires extensive genomic exploration, customisation or advanced bioinformatic analysis.

AI in diagnostics
A set of software models that can support signal reading, quality control, assisted interpretation, operational monitoring and data management, without replacing clinical and regulatory responsibility.

FAIR data
Principles of scientific data management aimed at making data findable, accessible, interoperable and reusable, particularly relevant when diagnostics become connected and multi-site.[11]

To discuss the future of molecular diagnostics is to discuss the very future of medicine. In recent years, the sector has demonstrated just how much a test can influence the timing of clinical decisions, the management of hospital workflows, epidemiological surveillance and access to care. The Lancet Commission on Diagnostics has described diagnostics as an essential component of healthcare systems, noting that a very large proportion of the world’s population continues to have limited or no access to adequate diagnostic tools.[1]

This perspective shifts the focus beyond technology. The point is not merely to have faster platforms, broader panels or more sophisticated algorithms. The point is to understand how these capabilities can be integrated into real-world systems: hospitals, clinical laboratories, regional networks, screening programmes, pharmaceutical companies and OEM partners. The molecular diagnostics of the future will be defined as much by its analytical precision as by its ability to be implemented, governed and made accessible.

For Helyx Industries S.p.A., this perspective is particularly important because it aligns with the group’s new industrial structure. Helyx no longer presents itself as a single technological entity, but as a comprehensive ecosystem: Hyris for distributed qPCR and the Hyris System™ platform; Vytro for PCR/IVD medical products and services and deep multiplexing; Mytho for custom NGS, bioinformatics and highly specialised services. This architecture allows us to view the future of diagnostics not as a race between technologies, but as a convergence of tools, data, quality and applications.

The aim of this article is to outline a credible strategic vision: fewer slogans, more concrete pathways. Decentralisation, AI, personalised medicine, the diagnostic cloud and global accessibility are not separate chapters. They are stages of the same transformation: the shift from diagnostics as a single test to diagnostics as a distributed and intelligent infrastructure.

Molecular diagnostics has often been portrayed as a matter of analytical performance: sensitivity, specificity, limit of detection, number of targets. These parameters remain fundamental, but they do not fully capture the value of the test. In a healthcare system under pressure, value also stems from what happens after the result: how quickly it is communicated, whether it is understandable, whether it is included in the patient’s record, and whether it enables a case to be isolated, a treatment chosen, a hospital admission avoided, or surveillance initiated.

The Lancet Commission has emphasised that improving access to diagnostics requires national strategy, funding, workforce, regulation, quality and integration with healthcare services.[1] This is also a key message for the industry: a diagnostic technology does not become relevant because it performs well in the laboratory, but because it can be integrated into a broader operational pathway. This leads to a strategic consequence: the future will not be dominated by a single platform. It will be dominated by architectures capable of connecting multiple levels. qPCR remains central when speed, repeatability and targeted measurement are required. Deep multiplexing becomes crucial when multiple targets need to be read in parallel in a clinical setting. NGS comes into play when the demand requires breadth, discovery, customisation or genomic stratification. Software brings together data, quality control and traceability.

This vision explains why Helyx’s One Group – Three Divisions model is strategically coherent: Hyris, Vytro and Mytho are not three commercial brands, but three complementary industrial approaches. Their convergence allows us to meet different needs without forcing a technology into contexts where it is not the best solution.

Decentralisation is one of the strongest trends in molecular diagnostics. It does not simply mean ‘carrying out tests outside the laboratory’; it means designing workflows in which the sample, the instrument, the software, quality control and reporting remain under control even when testing takes place close to the patient or at the point of decision-making.

The ECDC mapping of point-of-care devices for infectious diseases shows that POCT is now an integral part of surveillance, prevention and control strategies in Europe, albeit with significant differences between countries, settings and levels of implementation. [3] The literature on point-of-care laboratories in microbiology also highlights that reducing the distance between the sample and the analysis can shorten turnaround times and improve operational management, provided that the model is underpinned by governance and quality. [5]

The COV-19POC study brought this principle to life: the introduction of point-of-care molecular tests in hospitals reduced the average turnaround time from 21.3 hours to 1.7 hours, with implications for isolation management and patient flows. [4] This data emerged in a pandemic context, but the principle remains relevant: when the result arrives within the timeframe in which the clinical decision is made, the test ceases to be merely a technical output and becomes an organisational lever.

For Helyx, this trajectory is primarily embodied by Hyris. The Hyris System™ integrates bCUBE™, bAPP™ and reagents within a distributed qPCR framework. Peer-reviewed literature on bCUBE™ has demonstrated the potential of portable devices for performing rapid molecular tests in non-fully centralised settings.[14] A clinical evaluation using saliva samples also described bCUBE™ as a POCT innovation capable of reducing analysis time compared to traditional workflows. [15]

The key point is to avoid a misunderstanding: decentralisation does not mean fragmentation. A distributed network must not produce isolated local results, but rather data that is readable and comparable. The real challenge, therefore, is to bring testing closer to where it is needed whilst maintaining standards, supervision and traceability.

Artificial intelligence has become a permanent fixture in the discourse on diagnostics. However, in the molecular field, its value does not lie in its narrative impact. It lies in its ability to make certain processes more consistent, more traceable and less dependent on human variability: curve interpretation, anomaly flagging, quality control, instrument log management, reporting support and network monitoring.

The WHO guidance on ethics and governance of AI in health sets out six principles, including human autonomy, safety, transparency, accountability, equity and sustainability.[6] This is a crucial point: in the diagnostics sector, AI cannot be treated as a mere commercial accelerator. It must be validated, monitored and integrated into clear accountability systems. Regulation is moving in the same direction. In 2025, the IMDRF published the principles of Good Machine Learning Practice for medical devices incorporating AI/ML, adopting an approach focused on the entire product lifecycle.[7]

In Europe, the AI Act introduces a horizontal regulatory framework that intersects with medical regulations when AI is incorporated into high-impact devices and software. [8] For Helyx, AI should be viewed as a system-level component. In Hyris, it can support the operational quality of the distributed qPCR network; in Vytro, it can contribute to the standardisation of clinical workflows and the interpretation of multiplex panels; in Mytho, it naturally integrates into bioinformatics, NGS data analysis and the management of custom pipelines. In all three cases, however, the rule remains the same: useful AI means AI that can be validated, explained in the context of use and consistent with a quality system.

This is also the message for partners and investors. The value is not simply ‘having AI’ on a slide. The value lies in demonstrating where AI reduces variability, increases traceability, shortens a critical step or makes a process more scalable.

Personalised medicine is one of the fields in which molecular diagnostics most clearly demonstrates its value. Identifying mutations, response profiles, biomarkers or genomic signals enables the stratification of patients and treatment pathways. But caution is needed here too: personalisation does not simply mean collecting ‘more data’ indiscriminately. It means useful, validated data linked to clinical decisions. Ashley described precision medicine as a model in which genomic, phenotypic, environmental and clinical data converge to make prevention and treatment more targeted.[9] Meanwhile, the integration of genomics into healthcare systems has become a matter of global responsibility, requiring shared standards, evidence generation, data infrastructure and sustainable implementation pathways. [10]

From this perspective, Vytro and Mytho have different roles. Vytro is the division where clinical PCR, IVD kits and deep multiplexing can translate defined diagnostic questions into solutions usable by hospitals and laboratories. Mytho, on the other hand, operates at the NGS level: custom services, panel design, bioinformatics analysis and support for laboratories requiring broader or personalised genomic insights. The distinction is important: not everything that is personalised requires NGS, and not everything that is rapid can be reduced to PCR. The choice of technology depends on the demand.

The future of personalised medicine will therefore be hybrid. There will be scenarios where qPCR or clinical multiplexing is the most efficient solution; others where NGS is necessary to explore a complex genetic signature; and still others where the two technologies coexist, with NGS in the discovery or characterisation phase and PCR in the routine, control or monitoring phase.

Molecular diagnostics of the future will generate more data, in more locations and for a wider range of purposes: clinical, surveillance, quality assurance, logistics, applied research and product development. Without a coherent data architecture, this wealth of data risks becoming fragmented. The FAIR principles point the way forward: scientific data must be more easily discoverable, accessible, interoperable and reusable. [11] Applied to diagnostics, these principles do not mean the indiscriminate opening up of clinical data, but rather the design of systems capable of making data governable, auditable and reusable within the limits of privacy, security and intended use. The diagnostic cloud, therefore, should not be understood as a simple repository. It is the layer that allows a network of tools to be viewed as a system, not as a sum of devices. It enables the distribution of protocols, performance monitoring, log collection, result traceability, update management and multi-site quality support. In a decentralised network, this layer is as essential as the device itself.

In the Helyx model, this logic is particularly evident in Hyris: bCUBE™ is the instrumental node, bAPP™ is the software and organisational layer, whilst reagents and protocols represent the standardisation of the process. For Vytro, the same logic can support more robust clinical workflows; for Mytho, NGS data requires structured bioinformatics pipelines, annotation, interpretation and management. Data thus becomes the point of continuity between the three divisions.

One of the key messages in modern diagnostics concerns access. The WHO Essential Diagnostics List was created to help countries draw up national lists of essential tests and improve access to reliable diagnostic tools. [2] This issue is particularly important because diagnostic innovation risks widening the gap if it remains confined to a few highly specialised centres. The REASSURED framework for decentralised diagnostics sets out very specific requirements: tests that are real-time connected, easy to collect, affordable, sensitive, specific, user-friendly, rapid and robust, equipment-free or requiring simplified equipment, and deliverable to end-users.[13]

Not all these requirements are always fully achievable, but the framework helps assess whether a technology is truly usable in real-world settings, not just convincing in the laboratory. The strategic vision must therefore balance two imperatives: on the one hand, increasing analytical complexity, multiplexing, AI and genomic capabilities; on the other, making the system simpler to implement, maintain and control. This is where the industrial dimension becomes decisive. Accessibility is not built solely by lowering the price of the test; it is built through supply chains, training, reagent stability, intuitive software, technical support and documentable quality.

For Helyx, this means avoiding a one-size-fits-all approach. Hyris can bring distributed qPCR to operational settings where proximity is the critical factor. Vytro can serve clinical laboratories and IVD pathways where panels and validation are required. Mytho can support laboratories and specialist centres when the demand is for genomics, custom solutions and bioinformatics. Accessibility does not mean doing everything everywhere: it means putting the right technology in the right place.

Molecular diagnostics are becoming more powerful, but also more heavily regulated. In Europe, the IVDR has redefined the requirements, classification, evidence standards and responsibilities for in vitro diagnostic devices.[12]

This is particularly relevant for clinical multiplexing and for software that supports interpretation, reporting or data management. Regulation should not be viewed merely as a cost. It is a prerequisite for trust. In a sector where a result can guide isolation, treatment, screening or the choice of oncological pathway, documented quality becomes an integral part of industrial value. A competitive diagnostic product is not just one that performs well in development; it is one that maintains performance, traceability and governance as it scales up.

This reinforces the rationale behind the Helyx structure. Hyris oversees the platform and distribution side; Vytro oversees the clinical/IVD side; Mytho oversees the custom NGS and bioinformatics area. The separation between divisions also helps to better communicate responsibilities: not every technology has the same regulatory scope, not every product has the same user, and not every dataset requires the same form of interpretation.

The future of molecular diagnostics will not follow a linear path. Some segments will grow through proximity and decentralisation; others through the breadth of their testing panels; others through genomic depth and bioinformatics; and still others through software integration and quality control. Any group seeking to navigate this landscape must avoid two pitfalls: remaining overly focused on a single technology or, conversely, diluting its identity by spreading itself too thinly across too many messages.

The Helyx model seeks to strike this balance. Hyris is the distributed qPCR division: decentralised platform, hardware, software, reagents and workflows. Vytro is the division for clinical molecular biology, PCR/IVD medical products and services, and deep multiplexing for hospitals and laboratories. Mytho is the NGS and bioinformatics division, focused on custom services, bespoke panels and specialist support. Together, the three divisions enable a ‘beyond PCR’ narrative without denying the centrality of PCR in contexts where it remains the most suitable technology.

This structure is also beneficial for partners. A clinical laboratory seeking IVD solutions thinks differently from an OEM partner interested in distributed workflows; a genomics centre requiring custom NGS panels has different needs from a regional network that needs to reduce TAT. Helyx’s strength lies in its ability to respond with distinct scopes, yet within a shared industrial vision.

Q: When we talk about the future of molecular diagnostics, what is the most significant change to take on board?
Stefano Lo Priore: The most significant change is that diagnostics can no longer be viewed as an isolated step. It is not simply a case of ‘I take a test and get a result’. It is an infrastructure that must be integrated into the clinical pathway, the local healthcare system, the data, and the healthcare system’s capacity to respond. Technology matters immensely, but it is not enough on its own. Value is created when the test reaches the right place, at the right time, with controlled quality and a result that can actually be used.

Q: Decentralisation is often described as moving the test out of the laboratory. Is that definition sufficient?
Stefano Lo Priore: No. Moving a test does not automatically create value. Decentralisation only works if it remains governed. You need protocols, traceability, software, training and quality control. Otherwise, you risk multiplying testing sites without creating a network. Our approach is different: bringing diagnostics closer to where they are needed, but within a shared system. This is where a platform like Hyris becomes strategic: it is not just the tool, but the way the tool fits into a workflow.

Q: How do Hyris, Vytro and Mytho fit into this vision?
Stefano Lo Priore: The three divisions are precisely designed to avoid confusion. Hyris is the distributed platform: qPCR, software, reagents and decentralised workflows. Vytro is the clinical front, where PCR becomes a medical product and service for hospitals and laboratories, with an IVD approach and deep multiplexing. Mytho is the NGS and bioinformatics area, so a different level: more customised, more specialised, closer to the needs of geneticists and advanced laboratories. We don’t want to say that one technology solves everything. We want to build the right answer for every question.

Q: AI is a much-used term. Where do you see its real value in diagnostics?
Stefano Lo Priore: The real value isn’t in replacing the professional. It’s in helping them work better. In diagnostics, AI must reduce noise, not create it. It can help interpret signals, identify anomalies, standardise controls, monitor instruments, and speed up a process. But it must be validated and governed. I don’t believe in AI as a gimmick. I believe in AI as part of a quality system.

Q: What role will NGS play in the future strategy?
Stefano Lo Priore: NGS is an extraordinary technology when the situation calls for depth. But precisely for this reason, it must not be trivialised. With Mytho, we want to approach it seriously: custom panels, bioinformatics, dialogue with the laboratory and the geneticist. It is not a generic catalogue. It is a specialist approach. The interesting thing is that NGS and PCR are not enemies. They can be complementary: one can open up the field, the other can translate certain signals into a faster, more repeatable routine.

Q: What is the message for investors, partners and institutions?
Stefano Lo Priore: The message is that molecular diagnostics is a strategic lever, not just a technology market. Anyone investing in this sector must look beyond the individual product: they must look at the platform, quality, data, regulation, scalability and the ability to build partnerships. Helyx was founded for this very reason: to be an industrial group capable of linking scientific innovation with practical application. The vision is ambitious, but very practical: to make diagnostics more accessible, smarter and more reliable.

The future of molecular diagnostics will be shaped by a combination of proximity, automation, precision, data and access. Decentralisation will reduce the distance between testing and decision-making; AI will help standardise certain steps; personalised medicine will increase the need for biomarkers and genomic information; the cloud will transform isolated tools into networks; and regulation will ensure that only truly scalable models are adopted.

The trajectory is clear: diagnostics will no longer be merely a technical function behind the scenes, but an active component of predictive, preventive and personalised medicine. However, this evolution will require restraint. Not all tests need to be decentralised; not all data requires AI; not every clinical question requires NGS. The future will be strong where it is appropriate.

Within this framework, Helyx Industries S.p.A. can be seen as a group built to cover three complementary levels. Hyris makes qPCR distributed, connected and operational. Vytro takes clinical PCR towards deep multiplexing and IVD pathways. Mytho opens up the NGS and custom bioinformatics front. The vision is not to replace one technology with another, but to build an ecosystem capable of selecting the right tool for every problem. For healthcare and industry stakeholders, the decisive question will not be ‘which is the most innovative technology?’, but ‘which diagnostic infrastructure makes the decision more timely, reliable and sustainable?’. Much of the future value of molecular diagnostics will hinge on this question.