BioMerieux, the factory producing hi-tech devices to combat antibiotic resistance

Responding to supermicrobes with increasingly targeted and appropriate weapons. In the silence of the laboratories - but amidst the din of the headlines about the "silent pandemic" from antibiotic-resistant and care-related infections - the challenge is to counter a big killer emergency that causes 5 million deaths a year worldwide, between direct and indirect causes. And which in the European Union alone claims 33 thousand victims a year among the 670 thousand patients affected. With a sad contribution from Italy, the 'black jersey' in the EU: 11 thousand deaths from infections recorded in a single year and the prospect of totalling up to 450 thousand in 2050, if a drastic change of course is not implemented. And yet, in Italy alone, experts estimate that 3,300 lives could be saved, i.e. 30% less than today's deaths, thanks to the use of new diagnostic tools capable of identifying within a few hours both the pathogens responsible for an infection and the drugs to which they are most sensitive and which must therefore be administered to the patient. They call it 'antimicrobial stewardship' and it is that complex of interventions aimed at optimising the use of antibiotics while reducing the spread of resistance.

Not least because prevention is no longer enough: even in Italy, with 8% of hospitalised patients becoming infected, good practices such as the sacrosanct hand washing - still partly disregarded - must be flanked by a proactive approach. Under the slogan: 'to each patient the right antibiotic and only if and how much is needed'. The benefits of rapid diagnostic tests make it possible to aim straight for the most appropriate treatment: the priorities are to understand whether a patient has a viral or bacterial infection, to identify which bacterium is causing the infection - and consequently whether it is sensitive or resistant to antibiotics - and finally to choose the most appropriate antibiotic. "We are at the point where, in order to combat the advance of 'super-microbes' - bacteria and fungi that have learnt to resist many of the treatments available today - we need to resort to innovative, cutting-edge diagnostic strategies that enable us to quickly identify drugs capable of defeating them," explains Pierangelo Clerici, president of the Italian Clinical Microbiologists Association Amcli. "According to our estimates, with these new diagnostic tests we could reduce deaths by more than 30%. To the saving of human lives would be added, a fact of no small importance, lower outlays amounting to billions. If only one thinks, as Gian Maria Rossolini, Professor of Microbiology and Clinical Microbiology in Florence and Director of Microbiology and Virology at Careggi, reports, that 'in Italy direct costs amount to about 2.4 billion per year, against an estimated 2.7 million admissions for antibiotic resistance'.

In the face of the emergency, both institutions and companies are trying to run for cover. The Ministry of Health's National Plan to Combat Antibiotic Resistance 2022-2025 aims to strengthen prevention and surveillance of ICAs (care-associated infections), strengthen the OneHealth approach, promote the appropriate use of antibiotics and educate the population on the risks of overuse. But also to promote innovation and research on prevention, diagnosis and treatment, and this is where the national strategy is joined by business. "Our world is highly technological with a very rapid rate of innovation of about three years," explains Nicola Barni, president of Confindustria medical devices. "This is why research is the lifeblood for the development of the sector and for the emergence of increasingly cutting-edge technologies. In order to protect people's health, we must support all the companies in Italy that want to do research, generate GDP and create a skilled workforce. We must encourage and promote an industrial policy that is as dynamic and attractive as possible for companies operating in our country. But beware,' Barni warns, expanding on his reasoning, 'the SSN is now at a crossroads, and without new governance, including in the medical device sector, that overcomes the logic of silos and considers the patient's entire pathway from prevention to diagnosis to therapy and follow-up, sustainability will remain a pipe dream.

Teaming up and activating partnerships is one of the possible recipes: such as the one put in place by the Policlinico Gemelli Irccs with the diagnostics multinational bioMerieux, which has led to the birth of the Antimicrobial Stewardship Centre of Excellence (Ams Coe) at the Roman Polyclinic. The tenth, among those realised by bioMerieux with as many partners in the world and the second in Europe, which in this case envisages a three-year project to accelerate the impact of diagnostics in the fight against antibiotic resistance. bioMerieux - which originated way back in 1897 when, as a student of Louis Pasteur, Marcel Mérieux decided to set up the first laboratory - has 14 research and development centres worldwide, in which it invests 12.5% of its turnover, 80% of which focus on the fight against antimicrobial resistance. And today it sharpens its weapons against super microbes right here in Italy, where it landed in 1987, in Bagno a Ripoli near Florence. "We have chosen to invest 9 million euros in a new hub called Innovation Power House, dedicated to the research and development of solutions against infectious diseases and antibiotic resistance," explains Stathis Chorianopoulos, vice president & general manager, Adriatic bioMérieux Italia, in presenting the three-storey building where research and innovation of excellence is carried out. With space freed up to make room for cutting-edge diagnostic equipment and, in the future, new employees. "Today we employ 310 people, and thanks to this investment we expect to increase the number of employees by around 10%, thanks to an internal reorganisation of the production lines and research and development spaces, which will be able to make use of the most advanced instrumentation," Chorianopoulos continues.

In detail, the Innovation Power House includes a semi-anechoic chamber for carrying out electromagnetic compatibility tests on instruments in the prototyping and development phase, a climatic chamber used to simulate the environmental conditions to which electronic systems may be subjected during normal use, and a biological laboratory. "This laboratory," continues Chorianopoulos, "is crucial in order to optimise the development of in vitro diagnostic instruments by integrating biological samples as early as possible in the design phase, with the aim of reducing the risk of problems during the final validation phase. All the state-of-the-art equipment in the R&D department of the Innovation Power House is now essential for the R&D department to speed up the creation of prototypes and make development more agile. Being able to do most of the testing directly in the new in-house laboratories will speed up development and make it more autonomous. To the new facility in Bagno a Ripoli, bioMerieux has also brought production - which is only here in Italy and in the US - of Vitek MS Prime, a latest-generation diagnostic system based on mass spectrometry that allows rapid detection of microbial species present in a biological sample.