Diagante: improving the preservation of solid samples
Diagante, a young start-up based in the Paris region, aims to reduce the number of false positives in the analysis of solid microbiological samples. To achieve this, its three co-founders have developed a patented kit that can be used to store samples for up to 72 hours.
Founded in 2020, the start-up Diagante promises to improve the analysis of solid samples. Its story begins with professor Martin Rottman from the Laboratory for Infection and Chronic Inflammation (2I - Univ. Paris-Saclay/French National Institute of Health and Medical Research, INSERM/UVSQ) and Raymond Poincaré University Hospital (Garches/AP-HP), who in 2020, had a patent on the preservation of solid samples, filed in France in 2013, granted in Europe and the USA. He subsequently co-founded Diagante with Cécile Chevalier, a HEC graduate specialising in finance and business and co-chair of French Tech Paris-Saclay and Virginie Lebidois, who has a background in pharmaceuticals. Cécile Chevalier became CEO, while Virginie Lebidois assumed the role of COO, in charge of industrial and regulatory operations. Prof. Rottman took over responsibility for scientific and medical aspects (CSO).
A patented kit
"We started with the question, as microbiologists: how can we respond to the difficulty of providing a good diagnosis regardless of the sample collection method? Currently, for bone and joint infections, 30% of samples are false positives. In most cases, the pathogen is present, but we can't detect it," explains Cécile Chevalier. Solid samples must be processed within two hours to avoid information loss related to the death of bacteria and microorganisms. The CEO continues: "The very organisation of laboratories into technical platforms, which are increasingly centralised, sometimes with subcontractors, leads to delays." In order to reduce the number of false negatives, Diagante has developed a device that enables solid samples and their microorganisms to be stored for up to 72 hours at room temperature. With the kit sold by Diagante, false negative rates will drop to 5%.
The start-up's solution consists of a double-packaged vial containing a liquid transport medium and a patented bead system called TISSUtainer®. "When a solid sample is taken, once it has been transported, the laboratories have to prepare it for analysis. Previously, pestle and mortar techniques were used. We opted for a grinding system with a set of beads, so we can extract organic mass without destroying the bacteria. At the end of the process, the sample is liquid and the technician can analyse it through the usual procedures. This simplifies the diagnosis and ensures its accuracy," adds Cécile Chevalier.
TISSUtainer® was originally developed for bone and joint infections. "Right from the design phase, we quickly realised, through discussions with surgeons, that solid samples also included soft tissues (heart, blood vessels, etc.). These are valuable samples which are difficult to handle, but contain a lot of information," says the CEO. Diagante has therefore adapted its solution so that it can be used on any type of solid samples.
Evaluation phases
Diagante paid close attention to the quality of its raw materials in order to prevent any factors that could compromise the performance of its device. The co-founders also considered the environmental impact of their product. But, like all infectious healthcare waste, the vials are collected and treated, and often incinerated, by specialists. "We did a lot of work on the beads, to find the optimum balance between performance and the quantity of material used," adds the CEO.
Although TISSUtainer® obtained CE marking in June 2024, numerous studies are still underway, because although clinical evaluations are not mandatory for this type of device, hospitals still need to compare this new solution with those they use on a daily basis. Similarly, analytical laboratories must document the evolution of their processes. "Professor Rottman is in contact with reference centres in Strasbourg. He is currently working on a two-year clinical study protocol involving 80 patients with joint infections. The aim is to test four sample processing methods, including our own," explains Cécile Chevalier.
Market launch in 2025
After being incubated at Paris & Co Santé for two and a half years and accelerated at Wilco, Diagante is now based at the Simone Veil - Health Faculty at the Université de Versailles - Saint-Quentin-en-Yvelines (UVSQ), in Montigny-le-Bretonneux (Yvelines). "For us, the support of the UVSQ and Université Paris-Saclay is very important. It's essential to be connected to this ecosystem because it's a showcase which promotes excellence. The local roots are key for us," explains Cécile Chevalier.
The start-up, which now employs six people, is in the early stages of its commercialisation phase. The design and development of the TISSUtainer® are now complete. Diagante subcontracts the final kit assembly and sterilisation to an industrial partner in Normandy. After a first audit in June 2024, Diagante obtained ISO 13485 certification, an international standard specifying the requirements of quality management systems for medical devices and related services. During this audit, it also received CE marking for TISSUtainer® based on the new European Regulation 2017/746 on In Vitro Diagnostic Medical Devices, which opens the doors to the European market. "We also have marketing authorisation in the UK. We are in talks with distributors for distribution in Italy and the Nordic countries, as well as in Germany, Spain and Belgium. In the longer term, we're seeking marketing authorisation in the United States," says Cécile Chevalier.
Staying ahead of the curve, the start-up is already working on a new project, again on the issue of solid samples. The objective is to develop a kit for diagnosing infection that takes a more targeted approach to all types of microorganisms, and not just bacteria. This topic is the subject of an Industrial Research Training Agreement (CIFRE) thesis.
Labelled French Tech Seed, Deeptech by BPI and winner of the Île-de-France region's Innov'up Leader PIA call for projects in 2023, Diagante has no shortage of support. Two years ago, the company secured 1.1 million euros in a funding round. It is not yet financially self-sufficient, but the co-founders retain a majority stake. "We are in the process of launching a new funding round, with the aim of raising around 1.5 million euros. This will be used for our marketing and growth in Europe, as well as our new developments. Depending on our requirements, we will hire new employees during the year. Our mission is to continue developing reliable and rapid diagnostics by unlocking the full potential of solid samples. We are convinced that having the right diagnosis is the easiest and most cost-effective way of improving medical care for patients," concludes Diagante's CEO.