The case for the format.
The chemistry in a rapid test already works. What fails is everything built around it: the plastic cassette, the temperature limits, 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. That changes what a test weighs, what it costs to move, and how many tests one strip can carry.
The business model is reader plus roll: a customer buys one durable reader, then keeps buying sealed rolls.
Dianovo has closed its pre-seed round and is now raising a seed round.
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
Test kits for HIV, hepatitis B, and hepatitis C (2025)
The closest published figure to our first panel.
USD 10 billion+
Wider lateral-flow market (2025)
Projected to reach more than USD 17 billion by 2033.
Those tests ship with about 64,000 metric tons of material a year, going by published kit weights, and most of it does nothing for the result.
Many rapid tests are rated for storage up to 30°C. In the countries that need testing most, that limit is regularly exceeded, and the tests are used anyway, with no way to know whether the result still holds. CENTiV is designed to fix both.
The saving is in the logistics, not the price.
In our own cost model, the total cost of buying, shipping, using, and disposing of the tests comes out up to 45 percent lower. That figure is for the buyer CENTiV is designed for: a testing program in a low- or middle-income country, flying tests in at the higher end of typical freight rates, with one reader running about ten tests a day.
The saving comes from what the buyer stops paying for. The same number of tests takes far less space and weight to move, so freight is the largest part. Less staff time per test and less waste to handle add a few percentage points.
We assume CENTiV's planned price per test is the same as a cassette's. None of the saving depends on a lower price.
Total cost of ownership
Up to 45% lower
One reader, every panel.
Every CENTiV test runs on the same reader, and only the chemistry changes. That makes combined panels practical, testing for several infections at once without a separate device for each. Adding a test means new chemistry on the roll, not a new device, so a panel can be built for a program's needs rather than for a production run.
Example: the WHO triple panel
The World Health Organization's triple elimination initiative calls for every pregnant woman to be tested for HIV, syphilis, and hepatitis B. The first test to cover all three was prequalified in July 2025.
That product is one test card carrying three separate strips. The health worker draws blood into a tube, drops it onto each strip, adds buffer from a separate bottle to each, and runs a twenty-minute timer.
CENTiV puts the same three tests on one strip, read from a single fingerstick sample. Buffer built in; it releases only when the sample is applied. There is no vial to uncap, no timer to run, and no separate reagent to handle.
The timing works in our favor.
The buyer exists
By January 2025, 95 countries had adopted the dual HIV and syphilis rapid test in national policy, up from 78 in July 2024.
Policy is moving toward combined antenatal testing. The prequalified option runs the three tests on separate strips.
Heat is entering the specification
WHO's target product profile for point-of-care syphilis tests, published in 2021, sets the minimum at 12 months stable between 2 and 35°C, and the optimal level at 18 months between 0 and 50°C.
In 27 health facility medicine stores in southern Malawi, monitored from September 2021 to May 2022, temperatures ranged from 13.8 to 42°C. Twenty-four of the 27 recorded a peak above 30°C.
The CENTiV target is storage up to 50°C, freezing included.
Manufacturing is mature
Roll-to-roll is an established industrial process, so producing at volume can use existing factories instead of a custom process.
EU-origin advantage
Commission Implementing Regulation (EU) 2025/1197 excludes Chinese suppliers from EU public medical-device tenders valued at EUR 5 million or above, in force from June 30, 2025, for five years. It also caps Chinese-origin content at 50 percent of contract value.
CENTiV is developed in the EU and designed to be made there, with a supply chain that can be checked against that limit.
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. The EU Single-Use Plastics Directive does not cover medical devices, so the pressure comes from purchasing and carbon rules, not from a plastic ban.
The buyer we design for
The Global Fund bought 53 million HIV tests in 2023. In its rapid-test tender that year it took into account each supplier's plans to cut freight and to reduce plastic and packaging.
Its 2026 guidance points countries to lower-cost test kits and to self-testing as ways to save money. It names the goal of ending mother-to-child transmission of HIV, syphilis, and hepatitis B, and it calls data systems that can share information with each other essential.
Its budget for 2026 to 2028 is 17.9 percent smaller than for the three years before. CENTiV is designed for the antenatal tests it funds.
Nordic and French tenders
Norway has required climate and environmental criteria to carry at least 30 percent of the weighting in larger public tenders since 2024.
Since August 2026, every French public tender must score bids on at least one environmental criterion. Large French public buyers, hospitals included, must also run a responsible-purchasing scheme.
EU lifecycle-cost tenders
EU public purchasing rules let buyers score tenders on lifetime cost and environmental impact as well as price.
Those rules cover about EUR 1.8 trillion of public spending a year.
NHS carbon procurement
The NHS scores its suppliers on carbon. From April 2027, suppliers must publicly report their emissions, including those from their own supply chains.
The NHS says it intends to require a carbon footprint for each product from April 2028 and, from 2030, to award contracts only to suppliers that can show progress on cutting them.
Lower-carbon diagnostics gain at each of those steps.
UK single-use medtech roadmap
The UK Design for Life roadmap, published in 2024, commits the health system to move away from avoidable single-use medtech toward a circular model by 2045.
The packaging clock
The EU's new packaging rules apply from August 2026. From 2030, all packaging must be reduced to the least needed to do its job, and most packaging must be designed to be recycled.
Packaging around a diagnostic test is exempt from the recycling-design rule, and that exemption comes up for review in 2035. It is not exempt from the minimum-packaging rule.
A cassette sealed in a foil pouch has far more packaging to answer for than a roll.
The work ahead is engineering, not new science.
What is new is the format and how it is made. The open question is whether the chemistry that detects an infection performs as intended on a continuous roll.
Established chemistry
This kind of rapid-test chemistry has been studied for decades and is used in approved products. CENTiV builds on it.
Known materials and methods
The strip material, the reagents, and the reader optics all use well-understood materials and documented methods.
What is still to prove
What remains is getting the test to perform to specification on the roll, and making the roll and the reader work together.
Where the company stands.
Intellectual property
Two patent applications pending, filed in Sweden. Both filings have been examined by the Swedish Patent Office, and novel and inventive claims were found in both.
Who we work with
Dianovo works with research, clinical, regulatory, and commercial collaborators across Europe and South Africa.
Grant applications
Grant applications run in parallel with the seed round.
Ideon Science Park
Dianovo is based in the Medicon Valley life-science cluster, next to Lund University.
Regulatory path
The antenatal panel falls in Class D under the EU diagnostics regulation (IVDR), the highest risk class, because it includes HIV and hepatitis B. WHO prequalification does not wait for CE marking. We are putting a quality management system in place in line with ISO 13485 and the IVDR.
A staged path
The system is defined today. Next come a working integrated system, first clinical studies, and certification.
Healthcare is the entry point. The same production line can serve other markets.
These are expansion markets. Healthcare is the only near-term focus. Food safety, veterinary, drugs-of-abuse screening, and environmental testing run on the same manufacturing platform, each a separate market the same reader-plus-roll model can address later.
Food safety
Over USD 1 billion
Rapid strip tests for food safety, 2023. The whole food-safety testing market is about USD 19.7 billion.
Veterinary
USD 0.82 to 1.85 billion
Rapid tests for animals, from 2023 to a 2030 projection.
Drugs of abuse
USD 1.15 to 2.1 billion
Rapid strip tests for drug screening, from 2023 to a 2032 projection.
Environmental
Under USD 1 billion
Rapid strip tests for water and environmental monitoring, 2024. Environmental testing as a whole was USD 10.9 billion in 2025.
These figures count only rapid strip tests in each sector. The full sectors, across every testing technology, are larger.
Let's talk.
We closed our pre-seed round and are now raising our seed round to take CENTiV from a defined design to a working system, with the dispenser and reader built together and validated in the lab. Tell us about your fund and the stages you invest at, and we will send the current deck and set up a call.