Diagnostics rebuilt from the format up.
The chemistry in a rapid test already works. What fails is everything built around it: the plastic cassette, the cold chain, and a supply line that rarely reaches where testing is needed most. Dianovo changes the format. CENTiV makes diagnostics on a continuous cellulose roll instead of one molded cassette at a time, so a single reader runs the whole menu and each new test is new chemistry on the same hardware. The model is reader-plus-roll: one durable reader, recurring sealed rolls.
A large, recurring market carrying decades of built-in overhead.
2 billion+
Tests produced every year
More than two billion lateral-flow tests are produced annually.
USD 7.35 billion
Lead-indication market (2025)
The HIV, HBV, and HCV test-kit market, the first CENTiV indication.
USD 10 billion+
Wider lateral-flow market (2025)
Projected near USD 17 billion by 2033.
That volume ships with tens of thousands of tonnes of plastic and packaging that do nothing for the test, alongside a cold chain that dominates logistics in the markets that need testing most. The overhead is the opportunity: a reader-plus-roll platform built to remove it.
A lower all-in cost per test.
Counting the price of the test plus transport and waste handling, CENTiV can lower the cost of testing by roughly a third in typical procurement, and by up to 68 percent in the most favorable settings, where it ships with no cold chain and far less clinical waste. Modeled across EU, LMIC, and South African procurement scenarios.
One reader for the whole menu.
Every CENTiV test is new chemistry on the same reader. That makes multiplex panels practical without a separate device for each one, including combinations the single-cassette format leaves undone because a dedicated cassette is not worth tooling.
Example: the WHO triple panel
In 2025 the World Health Organization prequalified the first triple rapid test for HIV, hepatitis B, and syphilis, the combination its initiative on eliminating mother-to-child transmission calls for. Congenital syphilis alone causes about 661,000 cases each year. Panels like this are what a roll-based platform is built to deliver.
The timing is structural, not incidental.
The last unsolved part
The format is the last part of the rapid test that has not been re-engineered in about forty years. The chemistry works. The cassette around it does not.
Manufacturing is mature
Roll-to-roll is an established industrial process, so reaching volume draws on existing capability rather than a custom scale-up.
EU-origin advantage
EU Regulation 2025/1197 restricts Chinese suppliers from EU public medical-device tenders above EUR 5 million, in force from 30 June 2025. CENTiV is EU-origin, with component supply auditable for the cap.
The pressure is moving to the buyers.
Public buyers are being told to weigh waste and carbon, not only price. That shift favors a lower-waste device. Note that the EU Single-Use Plastics Directive exempts medical devices, so the leverage here is procurement and carbon rules, not a plastic ban.
NHS carbon procurement
The NHS scores suppliers on carbon. Per-product carbon footprinting is required from 2028, and contracting becomes progress-gated from 2030, so lower-footprint diagnostics gain an advantage.
NHS single-use phase-out
The NHS Design for Life roadmap, published in 2025, commits the health system to move away from avoidable single-use medtech toward a circular model by 2045.
Nordic and French tenders
Norway has required environmental criteria to carry at least 30 percent of the award weighting on above-threshold public tenders since 2024. France requires sustainable-procurement schemes for large public buyers, including hospitals.
EU lifecycle-cost tenders
EU public procurement rules let buyers weigh lifecycle cost and environmental impact in tender scoring, across roughly EUR 1.8 trillion of annual public spend.
The packaging clock
The EU Packaging and Packaging Waste Regulation took effect in 2025. In-vitro diagnostics are exempt until 2035 and then under review, which puts the incumbent cassette on a regulatory timeline.
Funders are diversifying supply
The Global Fund, PEPFAR, and Unitaid opened a supply-diversification pathway in 2023 that named HIV rapid tests as its first category, the exact segment of the CENTiV lead indication.
The bigger challenge is calibration, not the underlying science.
CENTiV is at an early technology-readiness stage and has not yet completed laboratory validation. That stage carries less scientific risk than it may appear to. The detection chemistry is established lateral-flow immunoassay, and the innovation is the format and the manufacturing, not the underlying assay. The open question is not whether lateral-flow detection works. It is whether it performs as intended on a continuous roll.
Established chemistry
Lateral-flow immunoassay is a mature detection method, documented across decades of literature and regulated products. CENTiV applies it. It does not reinvent it.
Known materials and methods
The substrate, reagents, and optical readout rely on well-characterized materials and documented methods, not unproven science.
Calibration, not invention
The work ahead is engineering, not discovery: calibrating the assay to specification on the roll format and integrating it with the reader.
What is already in place.
Intellectual property
Two patents pending under Swedish priority filings, covering the platform and a result-privacy mechanism.
Named collaborators
A network of research, clinical, regulatory, and commercial partners across Europe and South Africa.
Non-dilutive funding
Grant funding pursued in parallel with the current equity round.
Ideon Science Park
Hosted in the Medicon Valley life-science cluster, adjacent to Lund University.
Quality management
Under implementation in alignment with ISO 13485 and IVDR requirements. Not a certification claim.
A staged path
The system is defined today, with a staged path to prototype, clinical feasibility, and certification.
Healthcare is the entry point. The same line runs adjacent verticals.
These are expansion markets, not current targets. Healthcare is the sole near-term focus. Food safety, veterinary, biodefense, and environmental testing run on the same manufacturing platform, each a separate market the same reader-plus-roll model can address later.
Food safety
USD 19.66 to 31.22 billion
Rapid food safety testing, 2025 to 2030.
Veterinary
USD 10.71 to 19.00 billion
Veterinary diagnostics, 2024 to 2030.
Biodefense
USD 16.03 to 25.06 billion
Global biodefense, 2023 to 2032.
Environmental
USD 10.90 to 17.00 billion
Environmental testing, 2025 to 2032.
Let's talk.
We are raising to take CENTiV from system definition to an integrated prototype and analytical validation. Tell us about your fund and the stages you invest at, and we will send the current deck and set up a call.