Jack Englund Madsen, CEO of Diagonal Bio AB tells us about the companies progress and about an external testing of Diagonal's patented technology made by an accredited laboratory. Jack also answers questions about Diagonal's two technologies - LAMPlify™ and PANVIRAL™.
What is the most exciting news from Diagonal Bio AB
We just received the first results from external testing of our patented technology by an accredited laboratory, Centre of Diagnostic, at DTU Health Tech, Denmark. The Centre was involved in testing up to 12.000 covid samples per day during the covid pandemic in Denmark.
b. Quote “Diagonal’s instrument is easy to use, gives results at the same level as the usual PCR-based techniques and I see great potential in different market segments with a commercial version of the technology," says Helene Larsen, Director of Centre, Centre for Diagnostics, DTU Health Tech, Denmark1.
You came to the stock market in the midst of a pandemic. There are many who still see Diagonal as a "corona case". What do you say about that claim?
We used covid as proof of concept for our platform technology as everybody had tried both the PCR based tests, the gold standard of diagnostic testing, being accurate, but slow, complicated and expensive; and the QUICK test, delivering quick and easy handling, but highly unreliable diagnosis (in most cases below 50% accuracy). Diagonal´s patented technology delivers results within 10-15 minutes directly near the site of sampling, for example a patient if used as a tool for diagnostic, with the same accuracy as todays PCR based technologies, with extreme ease of use and a fraction of the costs of the PCR based technologies.
What is the biggest difference between you and your competitors?
Diagonals technology enables quick and accurate identification of genetic markers in essentially any type of genetic material (human, plant, virus, bacteria, animal etc) and can be used as a platform technology in the same way PCR is used today, in both the less regulated markets, for example, testing for harmful bacteria in water, food, feed, or for identification of genetic markers related to antimicrobial resistance in animals or pests or pathogens in the agricultural sector (animal and crop production) - LAMPlify. The patented technology can also be used for identification of genetic markers for quick and accurate diagnosis in the in-vitro diagnostic market segment – PANVIRAL.’
What does the market potential look like globally and how big a market share could a player like Diagonal take in the future?
Regardless if we are looking into the less regulated market segments, which is estimated to be valued ca. 37 BUSD or the diagnostic market segments, which is valued at 126 BUSD, there huge opportunities for Diagonals patented platform technology. Starting with the less regulated market segments will ensure faster commercialization and less dependency of the financial markets, which is why Diagonal have chosen to split their technology into two product lines: LAMPlify for the less regulated market segments; and PANVIRAL for the diagnostic market segments.
Can you tell us a little more about the company's plans for research and development, and how this will contribute to the company's growth and success?
Everything we are doing internal and external is with the focus on commercialization and to bring the company into a position where it can be financial sustainable, grow and capture market shares in the different market segments.
How can PANVIRAL be used to diagnose different types of infectious diseases, and how does the technology differ from other diagnostic products on the market?
The patented technology enables quick, accurate and cost effective identification of multiple genetic markers in parallel within 10-15 minutes directly where the sampling is taken, regardless if that, for example, is on a field during crop/animal production, or at the hospital for quick and accurate identification of genetic markers, for example, for infectious disease can reduce complications for the patients, reduce spread of infection and essentially safe lives. To our knowledge there are no other systems on the market offering the same benefits as Diagonals technology being: ultra fast (10-15min), accuracy in line with todays PCR based systems, ability to test up to 8 genetic markers or samples (for example patients) in parallel, highly flexible (new genetic markers can be added within a week under the best conditions), ease of use (3 clicks on the touch screen on the device to get the results) and cost efficient opening up for competing in both the high and low cost testing market segments.
How will LAMPlify and PANVIRAL contribute to improving the diagnosis of infectious diseases and improving patient care?
LAMPlify is intended for the less regulated market segments, for example, identification of genetic markers for bacteria in water, food, feed, or pests and pathogens during crop/animal production.
b. PANVIRAL is intended for use as a diagnostic tool for diagnosing patients for example infectious diseases.
What steps has Diagonal Bio taken to ensure that the products are reliable and provide accurate results when diagnosing diseases?
We have naturally refined the patented technology to ensure it performs according to expectations, but the real “measurement” comes from external validation via partner and collaborators – moving the evaluation to a third party for unbiased evaluation is the real strength. Results from the external study performed at Centre of Diagnostic, DTU Health Tech was of one of the most valuable milestones for Diagonal and shows that our idea is no longer just a fairytale but the real-deal with major commercial potential globally.
2023 has arrived. What are Diagonal Bio's main priorities and milestones to achieve during the year?
MEETING CHALLENGES IN IN-VITRO DIAGNOSTICS AND LESS REGULATED MARKET SEGMENTS
Identification of genetic markers for infectious disease is still dependent on analysis in centralized laboratories, which entails costly analyses. The logistics are complex and require the transport of samples from the sampling points to these laboratories. This also applies to the identification of genetic markers in less regulated market segments.
The ambition for LAMPlify during the year is to obtain a CE marking according to the Low Voltage Directive (LVD), which makes it possible to commercialize the test system in less regulated market segments.
The ambition for PANVIRAL remains to develop a universal in vitro diagnostic system for infectious diseases, which will create good conditions for future applications for regulatory approvals of PANVIRAL for use in in vitro diagnostics (CE marking according to EU-IVDR and/or US-FDA) at a later stage.
MARKETING AND SALES STRATEGY
Diagonal Bio has adapted the organization for the development of LAMPlify, as a first step, but also opens up for collaborations with partners and distributors. The company will focus on establishing potential partnerships and license agreements in new market segments and has established cooperation with OIM Sweden AB for commercial production.
Furthermore, the Company's platform technology will have an exclusivity protection until 2041 after validation of the patent approval in Europe, and the Company's sales strategy will be conducted according to the "Razor-Blade model" with consumables as the primary driver for revenue and profit growth.
A STRONG COMPANY ON ITS WAY TO VALUE-ENHANCING MILESTONES
By focusing on commercial activities and external research grants, the Board believes that the need for external financing will decrease in the long term.
In the coming year, Diagonal Bio is expected to achieve several important and value-adding milestones, including:
CE marking of LAMPlify in accordance with LVD
- External validation of the technology platform through collaboration with partners
- Create the first sales revenue from LAMPlify
Last autumn you concluded a royalty agreement with OIM. Can you tell us more about the royalty agreement and how it fits into Diagonal Bio's overall business strategy? Do you plan to continue creating similar agreements in the future?
During develop of our instrument we developed a minor component for which we signed a royalty agreement with OIM. The main purpose is to ensure our supply chain and tight control with our production costs, but there is naturally also a possibility for potential revenue in the future, although I will stress again this is not the main purpose.