Diagonal Bio

The Covid-19 pandemic made it clear that there is a global need for a quick, accurate, more reliable, holistic tool for diagnosis. Today's market is dominated by either accurate but slow, complicated and expensive PCR-based technologies or rapid antigen tests offering fast but unreliable (less than 50 % accuracy) diagnosis, typically for only one infectious disease at a time.

During the pandemic, the MedTech company Diagonal Bio was established in Lund with the vision to limit the spread of infectious diseases worldwide by creating a universal diagnostic platform, PANVIRAL. The platform should have the same accuracy as today's PCR-based technologies but deliver diagnosis within 10-15 minutes for multiple infectious diseases and/or patients in parallel. The idea was that this diagnostic platform could eventually be used at Point-of-Care, i.e., directly near the patients, at low cost and with extreme ease of use.

New platform technology in only two years

In just two years, Diagonal Bio has developed an entirely new and patented platform technology, where electrochemical sensors, in combination with LAMP (Loop Mediated Isothermal Amplification), can detect genetic markers in essentially any genetic material (DNA or RNA) for any organism (humans, animal, plant, bacteria, viruses etc.). The technology, which has the potential to cut costs compared to traditional PCR-based technologies by up to 70 %, is already patented, and the company is listed on the Nasdaq stock exchange in Stockholm.

The platform technology is based on three components: an instrument plus two types of consumables (cartridge and reaction mixes). The cartridge, which is currently prototype-manufactured in collaboration with Protolabs, is designed to run eight samples in parallel. This enables the detection of up to eight genetic markers in parallel within 10-15 minutes. In comparison, standard PCR-based methods where a sample has to be sent to a centralised lab for purification by expensive and complicated machinery before being analysed often mean that the result takes from several hours (at best) to several days (in general).

One of the applications for the new technology developed by Diagonal Bio is for fast, accurate, cost-efficient, Point-of-Care diagnosis, for example, at private clinics, hospitals, workplaces, airports, during surgery etc., where quick and accurate diagnosis would enable fast and correct treatment early on for patients, hence enabling speedier recovery, fewer complications and save lives and limit the spread of infectious disease.

Fast development

High quality is never an accident but requires informed decisions, hard work and experience. This is why Diagonal Bio has chosen to work with the fast-growing Swedish product development company OIM, and Protolabs, the world's fastest digital supplier of prototypes and components in small volumes.

Diagonal Bio uploaded its first CAD drawings of the prototype into Protolabs' automated solution and immediately received an initial analysis of how easy and cost-effective it would be to manufacture the first cartridge design. Unique to Protolabs are the technical consultants with expertise in manufacturing who then, together with Diagonal Bio, fine-tuned and optimised the design – a process that continues to develop.

 Diagonal Bio's CEO, Jack Egelund Madsen, explained:

"The process worked very smoothly and was very easy. The cartridge is produced by injection moulding. Making the mould took a total of four weeks from the first upload of our CAD drawings. From there, it only took a couple of days before we received the first prototypes:"

The patented platform technology has a wide range of possible uses, as many sectors can benefit from quick, accurate and cost-effective detection of multiple genetic markers in parallel in essentially any genetic material within 10-15 minutes, directly at the place of sampling.