BioFilm Control announces the publication of the results of its pilot study demonstrating the clinical relevance of its Antibiofilmogram® test

Friday, February 4th, 2022

Biofilm Control announces the publication of the results of its pilot study demonstrating the clinical relevance of its Antibiofilmogram® test, the first test providing the clinician with essential information on the effectiveness of antibiotics against biofilm.

Antibiotic resistance is one of the leading causes of death worldwide. The article published in The Lancet recently assesses the impact in terms of mortality at 1.27 million deaths directly linked to the loss of effectiveness of certain antibiotics, confirming a trend that could generate more than 10 million deaths by 2050 according to the WHO.

Antibiotic resistance is a natural phenomenon that is difficult to measure and diagnose due to the numerous and complex strategies implemented by bacteria.

Biofilm Control, French biotechnology company has opened up an unexplored avenue of research by attacking an enemy that makes antibiotics ineffective: biofilm. It is a viscous film produced by bacteria and protecting them from the action of antibiotics, thus causing an increasing number of therapeutic failures. Against this threat, BioFilm Control has developed the Antibiofilmogram®, the first test providing the clinician with essential information on the effectiveness of antibiotics against biofilm.

The pilot study, carried out in collaboration with clinicians from the CHU of Nîmes, the International Center for Research in Infectiology (CIRI), the Hospices Civils de Lyon and the CHU of Nantes, focused on a major public health problem, the foot ulcer in diabetic patients, one of the most frequently encountered complications (40 to 80% of patients). The infection of these ulcers is frequent and costly, and the lack of efficacy of treatments, in particular because of biofilms, leads to an increase in hospital admissions and a reduction in life expectancy. This major public health problem causes more than 8,000 amputations each year in France and 50,000 in Germany, with additional costs estimated at several hundred million euros for Health Insurance.

This prospective comparative multicenter and observational study aimed to analyze the performance of the Antibiofilmogram® test compared to the state of the art based on conventional antibiogram methods. Detecting the effectiveness of antibiotics on the biofilm behavior of bacteria rather than on their growth in liquid medium is a paradigm shift that reduces the time to results while also providing clinical benefit.

The results of the study showed that a favorable evolution of the wound was observed for 80% of the patients when the Antibiofilmogram® was consistent with the antibiotic therapy administered against 38% in the discordant group.

« This new technology is very promising to consider an antibiotic treatment strategy that takes into account information on the effectiveness of these antibiotics on biofilms, to improve wound healing. », according to the principal investigator Pr Albert Sotto, PU-PH at the University Hospital of Nîmes.

Thanks to these results, the Antibiofilmogram® BST Staph® test (for Biofilm Susceptibility Testing Staphylococcus) was developed in the ISO13485 environment of the company BioFilm Control and was CE marked in 2021. A complementary protocol is planned as part of a process that should lead to its registration with the Health Insurance in France and at the same time in Germany. Until then, the test being CE marked, BioFilm Control can meet the demands of clinicians and their patients facing recurrent infections where bacterial biofilm may be suspected (contact@biofilmcontrol.com).

The next planned indications are respiratory infections, in particular following Covid-19, and urinary tract infections.

The Single Interministerial Fund (FUI), the European Regional Development Fund (ERDF) and the Auvergne-Rhône Alpes Regional Council supported this study, the initial promoter of which was the Clinical Research and Innovation Department of the University Hospital of Nîmes.

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