Molecular diagnostics is increasingly a system rather than a collection of isolated technologies. Samples, reagents, instruments, software, quality and data must work together as a coherent chain. This is the premise of ‘Building the future of molecular diagnostics’, a White Paper developed by Helyx Industries to explain its transition from individual technology lines to an integrated industrial architecture.

The document is neither a scientific paper nor a simple corporate presentation. It is an institutional resource for investors, industrial and technology partners, stakeholders and decision-makers who need to understand not only what Helyx does, but also how the Group organises execution, risk, quality and growth capabilities across a value chain spanning distributed qPCR and next-generation sequencing.

The White Paper’s first theme is the ‘One Group – Three Divisions’ architecture. The aim is not to place different technologies under a single brand without distinction. It is to define separate operating scopes while sharing capabilities that have value across the Group: quality, industrialisation, production, software, intellectual property and data governance.

Hyris focuses on distributed qPCR and workflows that bring molecular capabilities into decentralised settings. Vytro operates in clinical PCR and IVD solutions for laboratories and hospitals, with an emphasis on standardisation, deep multiplexing and lifecycle management. Mytho covers NGS, including custom panels and advanced bioinformatics. Clear roles make roadmaps, metrics and risks easier to assess; Group integration reduces friction as technologies, processes and data connect.

The White Paper presents this structure as an execution choice: managing complexity while preserving accountability. In this context, vertical integration does not mean controlling the entire supply chain. It means coordinating the technology stack needed to make a workflow usable and repeatable.

The second theme is the industrial opportunity. Growth in molecular diagnostics is not treated as an automatic consequence of innovation or simply as market expansion. The central question is whether a clinical or operational need can be turned into a repeatable pathway: sample, test, result and decision.

The White Paper therefore connects structural drivers — decentralised testing, regulatory consolidation, growth in clinical genomics, screening and surveillance — with the constraints that determine actual scalability: continuity of supply, quality, deployment, channel access, support and the ability to integrate data into processes.

This framework also includes TAM/SAM/SOM market sizing. The estimates are presented as orders of magnitude, not guidance. The document distinguishes the total market, the market that can realistically be served and the share that could be obtained under prudent, transparent assumptions. Its purpose is not to turn market figures into a forecast, but to show how geographies, regulation, channels, production capacity and recurrence change the size of the opportunity that can actually be addressed.

The third theme is the medium-term direction. The White Paper’s vision for 2030 is not a linear forecast. It is an operational hypothesis about which capabilities will have lasting value if current trends continue to develop.

The first is the growth of hybrid diagnostic networks, in which distributed nodes and specialist hubs perform different but coordinated functions. The second is increasing information density through multiplexing and genomics, with tests selected according to the decision they must inform. The third is the maturation of the data value chain: traceability, interoperability, cybersecurity, auditability and responsible use of artificial intelligence become part of the industrial architecture rather than an optional layer.

The R&D roadmap is summarised in five principles: workflow first, modularity, quality by design, data governance and industrial scalability. The shared objective of the three Divisions is to turn scientific and technological innovation into processes that are repeatable, documented and sustainable over time.

Chapter 1 — Ecosystem overview. Industrial architecture, the scope of Hyris, Vytro and Mytho, Group synergies, milestones and reference cases.

Chapter 2 — Opportunity, growth and investment. Sector trends, demand drivers, scalability, business model and TAM/SAM/SOM market sizing.

Chapter 3 — Vision and future outlook. R&D roadmap, hybrid diagnostic networks, data governance, standardisation and an operational vision for 2030.

Appendices. A Q&A section for quick reference, further detail on market sizing and a glossary of key operational terms.