In recent years, multiplex PCR has emerged as a key technology for advanced molecular diagnostics. Unlike traditional (monoplex) PCR, which detects a single target per reaction, multiplex PCR allows multiple pathogens or genetic biomarkers to be detected with a single test. This represents a huge advantage for clinical laboratories and patients, especially in contexts such as respiratory and gastrointestinal infections or syndromic diagnostics, where it is crucial to test panels of different pathogens simultaneously. Studies and industry reports confirm that molecular multiplex panels are being increasingly adopted in clinical laboratories to replace traditional methods of microbial identification. This transition not only simplifies diagnostic workflows, but also significantly increases diagnostic capacity: for example, multiplex panels increase diagnostic yield by identifying pathogens that would escape traditional culture methods, generally resulting in greater sensitivity than cultures or antigen tests. The downside is technical and managerial complexity: to reach the patient's bedside or the laboratory bench, a new multiplex test must undergo a long development process. As noted in a recent review, multiplex PCR was developed in the late 1980s and has been used to identify deletions in the DMD gene responsible for Duchenne muscular dystrophy in a single reaction (Zhu et al., 2020).

In fact, bringing innovative technology from the laboratory to the market requires much more than a good idea or a working prototype. As the R&D team at Helyx Industries points out, "the real challenge in diagnostics is not just inventing a better test, but transforming it into a reliable, scientifically validated and regulatory-compliant product that is ready for large-scale production and everyday use." This process involves multidisciplinary research, rigorous testing, investment in industrialisation and careful management of quality and regulatory compliance. It is therefore not surprising that relatively few scientific innovations make it all the way to full commercialisation.

In this article, aimed at an audience of OEM partners, industrial laboratories, investors and R&D collaborators, we will explore step by step how a technology such as multiplex PCR can evolve from initial applied research to become a mature commercial diagnostic product. To guide us on this journey, we will use the concept of Technology Readiness Levels (TRL), a scale from 1 to 9 introduced by NASA and also adopted in the biotech field to measure the level of readiness of a technology[1]. We will therefore start from the lowest TRLs (basic research and laboratory prototypes) and work our way up to the highest TRLs (validated, certified and mass-produced system). Along the way, we will highlight: how the scientific validation of a new multiplex test takes place; how reagents are industrialised (e.g. freeze-dried preparations stable at room temperature); the importance of standardised and compliant software (from automated data analysis to cybersecurity requirements); the main regulatory challenges (from the new European IVDR to FDA registrations, including quality certifications such as ISO 13485); and finally, how to organise production and the supply chain to distribute the product on a global scale.

The Hyris Division has developed an integrated ecosystem (Hyris System™) consisting of a portable real-time PCR device (bCUBE™), an intelligent cloud application (bAPP™) and proprietary reagents. This patented technology stack – combined with certifications such as ISO 13485 and ISO 27001 and a path to IVDR compliance – illustrates a possible approach to accompanying multiplex PCR through all stages of technological growth to market.

Before delving into the individual stages, it is important to emphasise why this process is so crucial. Diagnostics is often referred to as the 'weak link' in global healthcare systems, despite having a huge impact on patients and the efficiency of care[2]. Having excellent diagnostic tools in the laboratory is of little use if these tools are not made widely available and accessible to clinicians and patients. The industrial development and commercialisation of new tests (such as multiplex tests) bridge this gap, translating scientific discoveries into concrete solutions that can be used in the real world. In the following sections, we will see how each step – from initial research to production – contributes to this ultimate goal.

Every technological innovation starts with a basic idea or discovery (TRL 1), often in academia or R&D laboratories. In the context of multiplex PCR, this could mean identifying a new combination of genetic targets to amplify together, or developing primers and probes that can work synergistically without interfering with each other. In this initial applied research phase, scientists conduct experiments to demonstrate the principle of operation: for example, that it is possible to amplify five different genes simultaneously in a test tube while maintaining acceptable sensitivity and specificity. This is essentially experimental and iterative work, in which PCR conditions (annealing temperatures, primer/probe concentrations, buffers, enzymes) are optimised to allow multiple reactions to coexist in parallel.

The TRL scale provides a useful framework: at TRL 1, only basic principles have been observed; at TRL 2, a hypothesis for application is developed (e.g., 'we can create a multiplex panel for X pathogens'); at TRL 3, an experimental proof-of-concept is realised. In biotechnology, reaching TRL 3 often means having preliminary in vitro data: perhaps the multiplex works on control samples (plasmids or cultured strains) in a laboratory setting. At this stage, the focus is on scientific feasibility: demonstrating that multiplex PCR can detect all desired targets and that the signal for each target is distinguishable (e.g., using probes with different fluorophores for each target in real-time PCR).

As we move towards TRL 3 and 4, the focus is on experimental demonstration of the working principle. In TRL 4, we talk about laboratory validation: the prototype system (which may simply be a mix of reagents and a PCR protocol) is tested more rigorously. For example, replicates are performed, detection limits are tested for each target, and the absence of cross-reactivity is verified. At this stage, simulated samples or inactivated clinical samples are often used to verify performance under more realistic conditions than pure controls.

It should be noted that many technical challenges typical of multiplex PCR already emerge at this initial stage: competition between primers (one target could amplify more efficiently and 'steal' reagents from others), formation of primer dimers, differences in amplification efficiency. Overcoming these challenges requires expertise in molecular biology and biochemistry (optimal primer design, concentration balancing) and often the use of dedicated primer design software. This is also where key elements of the test are defined: for example, the choice of fluorophores to avoid spectral overlap, and the definition of internal controls (e.g. housekeeping gene or extraction control) to ensure that the test works correctly.

A key indicator of success at this stage is reproducibility in the laboratory and the collection of initial data on sensitivity and specificity. For example, for a multiplex panel of respiratory pathogens, the goal might be to detect each pathogen down to a few copies of RNA (after RT) and without false positives in negative samples. If the data are promising, the next step is to move on to a more defined prototype: perhaps no longer just a protocol, but a standardised reagent kit in test tubes, or the integration of the test into a device. The transition from TRL 4 to TRL 5 involves moving out of the purely controlled laboratory setting and starting to test the system in a relevant environment: for example, on real clinical samples or in an external diagnostic laboratory.

Reaching TRL 4 means having demonstrated the concept in a controlled laboratory environment with a multiplex assay prototype. It is a scientific success, but still far from being a product. Many inventions remain at this stage: they work 'in theory' and in the hands of researchers, but further progress requires structured development work. From this point onwards, aspects such as validation with clinical standards, reproducible production, and compliance come into play. We then move on to the next phase: scientific validation and TRL 5-6.

Once it has passed the proof of concept stage in the laboratory, a new multiplex PCR must undergo a rigorous scientific validation process. This phase typically corresponds to TRLs 5 and 6, in which the prototype is tested in a relevant environment and then in a real operational context. In diagnostics, this means verifying the test on real clinical samples, comparing it with reference methods, and demonstrating its performance and robustness. Validation is divided into two main areas: analytical validation and clinical validation.

Analytical validation: this consists of examining the technical performance of the assay in detail. Parameters such as the limit of detection (LoD) for each target, linearity, precision (repeatability and reproducibility), specificity (absence of cross-reactivity with similar organisms), and robustness to variations (different operators, different PCR machines) are evaluated. In the case of multiplexing, it is also essential to evaluate the interaction between the different targets: for example, verifying that the presence of a high-concentration target does not inhibit the detection of a low-concentration target (competition effect). Panels of artificial samples with combinations of targets are tested to simulate co-infections.

Clinical validation: in parallel with or following the analysis, the multiplex is tested on clinical samples from patients at one or more clinical sites. The aim is to demonstrate that the test correctly identifies positive and negative patients against a gold standard (e.g. culture, sequencing, or validated single PCR tests). This is where measures such as clinical sensitivity (percentage of true positives detected) and clinical specificity (percentage of true negatives correctly identified) come into play. For a multiplex diagnostic test, hundreds or thousands of samples are often collected to ensure statistical robustness. In addition, any clinical impacts are evaluated: for example, whether the multiplex allows for faster or more accurate diagnosis of mixed infections.

During validation, it is common for the prototype to undergo adjustments. For example, it may emerge that a particular multiplex primer has lower efficiency and needs to be redesigned, or that the interpretation of a weak signal requires thresholds (Ct cutoff) to be optimised. This is part of the process: TRL 5-6 includes iterations and improvements. What matters is that each change is tested and validated again. Another important aspect of scientific validation is peer review: the publication of results in academic journals or presentation at conferences. Even if a company could develop a test internally, scrutiny by the scientific community increases credibility. For example, reviews such as Babady et al. (2018) in Clinical Microbiology Reviews discuss the growing adoption of multiplex panels and emphasise the importance of comparative and controlled studies. Publishing or at least collecting solid data is also critical to convincing investors and OEM partners that the technology has a robust scientific basis.

During TRL 5-6, partners often come into play: the developer company may collaborate with external laboratories or hospitals to conduct independent studies. In the case of Helyx Industries, the internal R&D team can conduct most of the validations within its own network of laboratories, thanks to its multidisciplinary expertise; but it can also form partnerships with pilot diagnostic centres to field test its Hyris System™. This allows early feedback to be gathered from end users (e.g. clinical biologists) on practical aspects: usability of the bCUBE™ device, bAPP™ software interface, management of multiplex results (e.g. how to present a comprehensible report if multiple pathogens test positive).

With the successful completion of scientific validation, the multiplex PCR technology under development can be considered proven from a technical and clinical point of view. We are now at TRL 6: the system has been demonstrated to work in a relevant environment, i.e. in conditions similar to those found in real-world operations (e.g. a clinical reference laboratory). This is a crucial milestone, but there are still equally important steps to take before the product can actually be brought to market. The next stage is to translate this validated prototype into a stable industrial process – in particular, to understand how to mass-produce reagents and kits while ensuring their stability, quality and compliance. This brings us to the industrialisation phase of reagents and components, corresponding to TRL 7-8.

Once the effectiveness of the multiplex test has been demonstrated, it must be made producible on an industrial scale while maintaining its performance. This is where many innovations encounter obstacles: performing a test in 10 test tubes in a laboratory is different from producing 10,000 identical marketable kits. The industrialisation of reagents involves standardising and optimising the chemical formulation, ensuring stability over time (shelf life), and making production repeatable and compliant with quality standards (e.g. ISO 9001 and 13485). At this stage, the company moves from the role of research laboratory to that of industrial manufacturer.

Stable formulation and shelf life

A crucial objective is to ensure that the multiplex kit has an adequate shelf life (ideally 12–24 months) and can withstand variable transport conditions. Many laboratory PCRs require storage at -20°C, which is impractical for global distribution. The industrial solution often adopted is freeze-drying or other techniques to create ambient-stable reagents. For example, Helyx Industries has developed proprietary reagents that remain effective at room temperature (ambient-stable), eliminating the need for a cold chain. This feature is a huge logistical advantage: as highlighted by studies in the field of field diagnostics, "freeze-dried PCR reagents maintain accuracy and reproducibility for at least 49 days at 37°C, indicating that they can be easily transported at room temperature for field applications". In other words, a multiplex test with stable, non-refrigerated reagents can reach remote laboratories or emergency settings without breaking the cold chain, making it immediately usable. Conversely, 'the need for refrigerated shipping and storage has so far been an obstacle to the on-site use of real-time PCR', as highlighted in a study on pathogen diagnostics at the local level. Industrialisation therefore aims to remove these obstacles: reagents are formulated with protective matrices (sugars, polymers) and lyophilised into dosed beads or pellets, which the end operator only needs to resuspend at the time of testing. The European JRC's ENGL guidelines on the design and implementation of multiplex real-time PCR methods are particularly useful at this stage, providing practical guidance on fluorophore selection, reaction controls and instruments (JRC ENGL, 2021).

GMP production and quality control

On an industrial scale, reagents must be produced in accordance with pharmaceutical or diagnostic quality standards (often referred to as GMP, Good Manufacturing Practices). Each batch of primers, probes or mastermixes must be synthesised and purified using validated processes, and then subjected to thorough quality control. This includes testing each production batch of the multiplex kit to verify its performance (sensitivity, specificity) before release onto the market. Companies implement certified quality systems (such as ISO 13485, which Helyx Industries possesses) precisely to ensure that each kit sold is equivalent to the validated prototype. For example, if the multiplex test is sold in kit form, each batch will have a Certificate of Analysis with performance results on internal control panels. In addition, traceability becomes essential: thanks to modern management systems (ERP/LIMS), every component of every kit can be traced (primer batch, enzyme batch, etc.), allowing any problems to be traced and targeted recalls to be made if necessary.

Packaging optimisation and ease of use

Industrialisation also means designing optimal packaging. For example, preparing strips of pre-filled tubes containing lyophilised reagents for each test, in a format compatible with the device (in the case of bCUBE™, for example, these could be specific test tubes that fit into the portable thermal cycler). The commercial packaging must include ready-to-use positive and negative controls, multilingual instructions for use, and labels with the information required by regulations (UDI code, expiry date, storage conditions, batches, etc.). All this is defined at this stage. Usability is an important competitive factor: for OEM partners or user laboratories, having easy-to-use kits (minimal handling, e.g. 'just add water and sample') makes all the difference. That is why many companies, including Helyx Industries, invest in ready-to-use, stable reagents, which reduce the possibility of human error (incorrect pipetting, contamination) and speed up the workflow.

Scaling up and automation

Moving from laboratory scale (where reagents may have been produced for a few hundred tests) to industrial scale often requires automation. Machinery for dispensing reagents accurately, batch freeze-drying lines, robots for assembling kits and packaging, environmental control systems (clean rooms) – all of this is part of the process. Automation reduces errors and increases production capacity. In a multiplex kit, where the composition of each reaction must be identical, precision is essential: even small variations could alter Ct values or sensitivity. The company must therefore invest in machinery and training.

In the specific case of Helyx Industries, the industrialisation of multiplex reagents has led to one of the company's strengths: proprietary ambient-stable reagents, the result of patented formulations. This patented know-how is part of Helyx Industries' IP assets and also represents a barrier to entry for potential competitors. Integrating a multiplex test into a portable device such as bCUBE™ would not be possible if the reagents had to be kept in a freezer at all times; thanks to its stabilised formulation, the Hyris System™ can be shipped and used even in unconventional settings (mobile clinics, remote sites) without advanced laboratory infrastructure. 

In summary, the industrialisation phase of reagents transforms the 'recipe' developed in the R&D laboratory into a replicable and stable 'product'. It is a costly and demanding phase, but essential for scalability. Once reagents and kits are industrialised (TRL 7), it is necessary to ensure that the digital and software components of the diagnostic system are equally robust and standardised. Let us now move on to software standardisation and digital integration.

In parallel with the industrialisation of physical components, the development of a modern diagnostic test requires the maturation of the software component. Multiplex PCR, especially when performed in real time and with many targets, produces large amounts of data: multiple amplification curves, threshold interpretations, algorithms to discriminate between positive and negative results, and control management. In addition, the diagnostic solution often includes software to guide the user and manage the results. In a TRL 7-8 context, the company must standardise and validate this software, making it compliant with regulations and integrable into clinical or industrial workflows.

Validation and certification of diagnostic software

A crucial element is that software, if an integral part of the medical device, is itself subject to quality requirements. Regulations such as IVDR and FDA guidelines require that software be developed according to Software Lifecycle Management principles (e.g., IEC 62304), with testing, documentation, and change management. Software that interprets multiplex results must be accurate: a bug could generate false negatives or false positives. Therefore, standardisation includes writing specifications, unit and integration testing, validation with datasets, and audit trails.

Interoperability and standard formats

During the standardisation phase, the output formats for results and any integration with other systems are defined. Clinical laboratories often require that the device software be able to communicate with internal LIS (Laboratory Information Systems), exporting results in standard formats. For OEM partners, the availability of an API or compatible interfaces can be a decisive factor. Helyx Industries, for example, has focused on bAPP™ as a cloud platform that centralises data from distributed bCUBE™ devices, enabling remote access to results and aggregate analyses. To ensure user confidence, the platform had to obtain certifications such as ISO 27001/27017/27018 on information and cloud security: this certifies that sensitive test data (e.g. patient information or diagnostic results) is protected in terms of confidentiality, integrity and availability. In diagnostic contexts, cyber security is as much a part of product quality as analytical accuracy – just think of the risks if clinical data were altered or stolen. Compliance with these standards and adherence to privacy-by-design practices therefore become essential standardisation points.

Usability and user interface

The software standardisation phase also includes the development of the UI/UX – the user experience. A multiplex test often produces complex outputs (e.g., amplification curves for 10 different targets in a single test). The software must present these results in a clear and interpretable way: for example, by using colours or indicators to show which pathogens have tested positive, providing threshold values (Ct values) and interpretative suggestions. In some cases, especially for decentralised instruments such as the bCUBE™, the user may not be an expert molecular biologist; therefore, the software (or linked app) must guide the operator step by step (guided workflow, on-screen instructions, process quality control such as verifying that the sample has been loaded correctly, etc.). Standardising the software also means creating these consistent user flows, testing them with real users (usability testing) and gathering feedback to improve their simplicity and accuracy of use. A sober and professional tone in messages, no excessive jargon, and multilingual localisation of the interface are part of these refinements.

Artificial intelligence and data analytics

A modern trend – and one that Helyx Industries is following – is to integrate AI algorithms into diagnostic software. For example, to analyse amplification curves in a more sophisticated way (detecting anomalies early, calculating quality indices), or to correlate multiplex data with epidemiological databases. Helyx Industries has patented its AI-driven cloud platform which, by learning from thousands of tests performed in the network, can continuously improve interpretation through constant feedback in the so-called post-market surveillance phase, i.e. the phase of monitoring the performance of the test after it has been placed on the market. Standardisation in this context requires the validation of artificial intelligence algorithms, demonstrating that they provide consistent and clinically valid outputs. Not only that: for regulatory purposes, if the algorithm evolves (machine learning), strict version control is required and often falls under an approval change control regime.

In summary, during the journey towards TRL 7-8, the developer consolidates the system software so that it is as robust as the hardware and reagents. Upon completion of this phase, the multiplex test is no longer just a chemical kit, but an integrated diagnostic system: hardware + reagents + software working harmoniously together. Helyx Industries, for example, offers a complete package with Hyris System™, in which bCUBE™, lyophilised multiplex reagents and bAPP™ cloud work together. Standardisation ensures that users anywhere in the world can use the system and obtain consistent, reliable results, with data that is protected and can be integrated into the local workflow. 

With such a ready and validated system (TRL 8, complete prototype tested in a real operating environment), the last mile before market launch concerns regulatory compliance. Even the best multiplex test cannot be sold and used clinically unless it is certified according to regulations. We are therefore tackling the regulation and certification phase.

In the field of diagnostics, compliance with regulatory requirements is as essential as technical performance. No laboratory or hospital will be able to routinely use a new multiplex test unless it has obtained the necessary authorisations from the competent authorities (e.g. CE-IVD marking in Europe, FDA authorisation in the US, etc.). Therefore, once the product is technically mature, it must be placed within the current regulatory framework and meet all the conditions. This phase is around TRL 8-9: it is, in fact, the prelude to commercial launch.

Classification and regulatory pathway

The first step is to determine how the product is classified according to regulations. Under the new European IVDR, most multiplex tests fall into class C or D (high risk, especially if they involve serious pathogens or use on critical samples), which requires the intervention of a Notified Body and rigorous clinical evidence. In practice, the company must prepare comprehensive Technical Documentation containing all information about the device: description and intended use, demonstrated analytical and clinical performance, risk management, software validation, production quality control, etc. This documentation is subject to external audit and review. The process culminates in CE marking and obtaining the CE certificate for the product, which allows it to be sold freely in the EU.

Helyx Industries, for example, through its Vytro Division, is following this very process to align its portfolio with the IVDR: as these are innovative multiplex products intended for the diagnosis of infections or other biomarkers, the company is preparing technical files and collaborating with a Notified Body for reviews, with the aim of obtaining CE IVDR certification (a strategic objective currently in progress).

In the United States, the process involves the FDA (Food and Drug Administration). Depending on the type of test, a 510(k) (premarket notification) or a De Novo/PMA (for devices without similar predicate devices already approved, often the more complex multiplex panels follow PMA) may be required. There are cases where certain hardware components may be 510(k) exempt – for example, a generic laboratory thermocycler is often exempt from 510(k) because it is considered a low-risk Class I device. Helyx Industries reports that its bCUBE™ device is among those exempt from 510(k) (being a generic PCR thermocycler, usable in research or as a platform, it does not require specific 510(k) clearance to be marketed in the US). This simplifies the entry of the hardware device into the American market. However, each specific diagnostic application (the multiplex test for a certain disease) will typically need to obtain authorisation – for example, in the form of an FDA-approved specific-use diagnostic kit, or via Emergency Use Authorisation in situations such as pandemics. Therefore, the regulatory strategy may be to enter the system as an open platform and then plan for clearance for individual multiplex panels.

Quality system certifications

We mentioned ISO 13485 – a practically mandatory requirement for presenting oneself to the authorities with credibility. A notified body or the FDA will inspect the company's production processes: Helyx Industries' ISO 13485 certification (already obtained) indicates that the company has a quality management system that complies with international requirements for medical devices. This covers design control, risk management (ISO 14971), supply control, traceability, non-compliance management and corrective actions, etc. Certifications such as ISO 27001 may also be relevant (especially if the product has cloud components – some regulations require IT security to be guaranteed, and having ISO 27001 is a strong signal in this regard).

Furthermore, regulations such as the IVDR emphasise concepts of post-market surveillance: the company must prepare plans to monitor the performance of the test after marketing (collection of feedback, incident reporting, updates if new strains or variants emerge, etc.). This must be planned in the pre-market phase and integrated into the regulatory documentation.

Testing in accredited centres and comparison with international standards: In some cases, in order to obtain approvals, the company's internal data must be supplemented or confirmed by independent assessments. For example, in the IVD sector, kits may be submitted to bodies such as reference laboratories, or participate in multicentre trials. The Notified Body may also request to see additional studies. All these steps lengthen the process but ensure third-party control over the reliability of the product.

Global regulatory framework

In addition to the EU and the US, if the product is to be sold globally, other registrations must be considered (e.g. UKCA for the UK, Health Canada, regulations in Asia-Pacific, etc.). Often, however, CE marking and FDA clearance are the main pillars and can facilitate other registrations by equivalence.

In general, the intent of the new regulations is clear: "to create a robust, transparent and sustainable regulatory framework that improves clinical safety and ensures fair market conditions"[2]. For companies such as Helyx Industries, this means greater commitment and documentation burdens, but also an opportunity to demonstrate the intrinsic quality of their multiplex solutions. Those who manage to obtain certifications and approvals for a multiplex test will have a significant competitive advantage, as they will join a relatively small group of players that comply with the new regulations (especially in Europe, where the IVDR transition is proving difficult for many smaller companies).

Upon completion of this regulatory phase, the multiplex PCR technology developed can boast of being an officially authorised diagnostic device. This is equivalent to reaching TRL 9: the product is ready for use in a real environment with all the necessary credentials. All that remains is to produce and distribute it effectively, topics we will address in the next section.

Once certifications have been obtained and the industrial process has been fine-tuned, the final phase begins: producing and distributing the product on a large scale. This phase includes aspects of supply chain, logistics, supplier management and demand planning. In terms of TRL, we are now at TRL 9 (operating system and on the market). Here too, the complexity is considerable, especially for diagnostic products that must guarantee consistent quality and availability.

Mass production and batch management

Large-scale production involves planning the manufacture of batches of multiplex kits. Each batch must follow standard procedures, with quality controls and documentation. The company must manage suppliers for raw materials (primers, probes, enzymes), packaging and consumables. Unlike generic products, a multiplex diagnostic kit is highly regulated: any change in supplier or raw material may require revalidation or document updates. Therefore, the supply chain must be robust and traceable.

Scaling the global supply chain

Distributing a diagnostic product also means managing international logistics, warehouses, local retailers or distributors, and technical support in the field. Multiplex reagents, if stable at room temperature, greatly simplify logistics as they do not require refrigerated transport (reducing costs and complexity). This can open up otherwise difficult markets: think of delivering test kits to hot countries with limited infrastructure – only possible if the reagents can tolerate the journey. "Over 40,000 IVD diagnostic products are available today, from centralised laboratory tests to point-of-care tests, and near-patient tests help reduce costs and improve the efficiency of care, especially in resource-limited settings"[4]. . A portable multiplex system such as Helyx Industries' fits perfectly into this scenario: with its small size (the bCUBE™ is a compact cube) and robust reagents, it can be shipped and implemented even in peripheral clinics or in the field. The supply chain must take into account how to constantly replenish consumables (cartridges, kits) to customers, perhaps by setting up regional distribution centres. Furthermore, supporting end users is part of the delivery: this means having a technical support and training service. For example, Helyx Industries could offer online training through bAPP™, or have application specialists who help new customers implement multiplex testing in their laboratories.

Economic and market considerations

The final step in completing the transition from research to product is to ensure that the product is economically viable and attractive to the market. After significant investment in R&D, validation and compliance, the company must define an appropriate price and business model: direct sale of kits? Rental or sale of instruments with periodic purchase of reagents (razor-and-blades model)? OEM collaboration with other companies that integrate the panel into their systems? These are strategic choices. The market for multiplex solutions is growing strongly – according to MarketsandMarkets analysis, the global multiplex assay market (which includes multiplex PCR and other technologies) is estimated at £3.5 billion in 2022 and projected to reach £5.3 billion by 2027, with a CAGR of ~8.8%[5]. This indicates strong interest and space for those bringing innovative products to market. However, it is a competitive sector dominated by a few large players. As a new entrant, Helyx Industries aims to differentiate itself in high-value niches (e.g., portability, unmatched speed, customised OEM panels, etc.) and intellectual property (patents on reagents, AI, and hardware) to carve out its share. In conclusion, when a multiplex PCR product reaches the market, it represents the convergence of research, industrial development, regulation and logistics. Every piece of the puzzle must work. An excellent laboratory test that cannot be mass-produced or reliably distributed will fail. Instead, a well-engineered system with a solid supply chain can reach laboratories around the world.

The journey of multiplex PCR from research to production is a prime example of how biomedical technology can be transformed into concrete innovation. We have seen how the process goes through different levels of technological maturity: from initial discovery and proof-of-concept (TRL 1-3), to laboratory and clinical validation (TRL 4-6), to industrialisation and standardisation (TRL 7-8), to certification and commercial scalability (TRL 9). Each phase presents specific challenges: from multiplex biochemistry and primer design, to reagent stabilisation, software compliance and cybersecurity, IVDR/FDA regulation, to production and logistics.

From a strategic point of view, it is essential for players such as OEMs, industrial laboratories, investors and R&D partners to fully understand these dynamics. A company that successfully completes this process demonstrates not only scientific innovation, but also industrial execution and compliance capabilities, which reduce risk and increase value. For an OEM partner, knowing that a multiplex test has been industrialised and certified means that it can be integrated into its systems with confidence. For an investor, it means that the technology has passed the 'valley of death' of development and has the potential to generate scalable revenue.

In just a few years, Helyx Industries has integrated an entire diagnostic value chain – hardware, reagents and software – focusing on differentiators such as portability and cloud AI. Within the Hyris Division, this translates into the Hyris System™ distributed qPCR platform, while for clinical applications and IVD kits, the Vytro Division oversees the certification process. The certifications obtained (ISO 13485 for quality, ISO 27001 and similar for IT security) and those in progress (CE-IVDR marking) testify to the company's commitment to meeting the highest international standards, a necessary condition for playing a leading role in the global market. At the same time, the company has secured its innovation with patents on key aspects (multiplex chemistry, software platform, instrument design), guaranteeing valuable intangible assets.

Equally important, Helyx Industries has invested in its interdisciplinary R&D team, capable of tackling challenges ranging from enzymology to cloud programming: this holistic approach is probably one of the reasons why it has managed to bring its Hyris System™ technology close to market readiness in a relatively short time.

Looking ahead, the ability to rapidly translate research into practical solutions will be a key competitive factor. Demand for multiplex testing continues to grow, driven by the need for faster and more comprehensive diagnoses, and trends such as personalised medicine and epidemiological surveillance. Furthermore, innovations such as ambient-stable reagents, portable devices and integrated AI can further expand the use of multiplex PCR beyond centralised laboratories, bringing it to decentralised settings and resource-limited countries. As the WHO points out, improving access to reliable diagnostics is crucial to strengthening global health systems.

In conclusion, the journey of multiplex PCR from research to production shows us how "scientific innovation comes to fruition when it becomes a usable product." Each stage involves different skills and responsibilities, but they all contribute to the same goal: putting better diagnostic tools in the hands of doctors and patients. In the case of Helyx Industries and other similar companies, this means contributing to a future in which complex tests such as multiplex tests can be performed wherever they are needed, from high-tech hospitals to small rural clinics, quickly, reliably and safely. It is an ambitious goal, but one that is achievable if scientific research and industrial vision go hand in hand.