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Ultra-fast Antimicrobial Susceptibility Test for diagnosing antimicrobial resistance to provide personalized antibiotic treatments

Periodic Reporting for period 1 - Nanosynex (Ultra-fast Antimicrobial Susceptibility Test for diagnosing antimicrobial resistance to provide personalized antibiotic treatments)

Reporting period: 2020-10-01 to 2021-09-30

The devastating consequences of excessive use of antibiotics have been recognized by the World Health Organization as one of the greatest threats to global health.
Antimicrobial Resistance (AMR) is the ability of microorganisms to resist to antibiotics treatment. This contributes to 700,000 deaths a year and is expected to cause 10 million deaths by 2050.
One of the main causes of AMR is the actual antibiotics prescription practice, which is inaccurate, since it is made by doctors using empirical antibiotic therapy based on a “clinical educated guess” (using their expertise, intuition and professional judgement) before the confirmation of a definitive medical diagnosis, since current AST (Antimicrobial Susceptibility Testing) diagnostic methods take too long (a few days) to lead to clinically actionable results.
As a consequence, the following pain points are present: untimely results, impersonalized treatment, growing bacterial resistance allowing for the emergence of “superbugs” in the environment and increased hospitalization costs.
In particular, the financial implications of AMR proliferation are devastating for the global healthcare system and the economy. Treating AMR-related infections requires prolonged and costlier treatments, extended hospital stays, additional doctor visits and healthcare infrastructures such as isolated hospital wards. In addition, sick people don’t go to work and/or can spread the infection, leading to a chain reaction of reduced economic activity: Research shows that a continued rise in resistance by 2050 would lead to a reduction of 2% to 3.5% in GDP and cost the world up to 100 trillion USD.
By addressing this unmet for fast, efficient and reliable AST , Nanosynex will enable laboratories to optimize their AST workflow and accelerate the process of providing guidance for prescription of targeted antibiotics to patients, which in turn will help achieve the following overall objectives: (i) Help patients recover in a shorter time lapse, since they get the appropriate antibiotic therapy; (ii) Prevent the spread of resistant bacteria in the environment and future pandemics by detecting them at an earlier time; (iii) Limit LOS (length of stay) and prolonged hospitalization due to failed treatment options, hence reducing the healthcare system costs.
Nanosynex’s approach is to develop a first rapid AST product that will first focus on clinical isolates from urinary tract samples, mainly responsible of urinary tract infections (UTIs), but can be applied to any other sample and impact all related clinical indications. It is composed of three main components:
1) Nanosynex disposable panel test cards: each card is composed of multiple microfluidic arrays composed of 50+ nanowells each, called Stationary Nanoliter Droplet Arrays (SNDA). The multiple SNDAs of the card are interconnected and loaded in a single step. The final target card product should test a panel at least 10 antibiotics at several different concentrations and positive/negative controls. The cards are to be vacuum-sealed, single-use and disposable. The first MVP developed during the first year of the project consists in a fully functionalized, injection molded card meeting the minimum viable product target panel of 10 antibiotics at several different concentrations plus on-board controls. It is now in validation process. A second generation with an increased number of test conditions has been designed but not yet produced.
2) Nanosynex benchtop reader: the reader is an automatic computer controlled system that will be able to hold multiple cards (corresponding to multiple patients’ samples), which will be loaded in on a rolling basis. The user inserts the cards into the reader, where consequently, each card is time laps imaged, analysed, and finally results will be retrieved and reported when ready.
The first MVP reader achieved during the first year of the project is capable of reading 6 First MVP cards per run. This First MVP configuration is what will be taken to the clinic for clinical testing during the next months.
3) Nanosynex real time AST algorithm software: it is integrated to the Nanosynex Benchtop Reader and analyses the fluorescent signals from time lapse images allowing to model bacterial growth in real time, and is used to determine the MICs (Minimum Inhibitory Concentration) and make S/I/R (Susceptible/Intermediate/Resistant) determinations. For each patient’s sample, the software generates a report, called an antibiogram, listing the all the antibiotics tested along with their corresponding determinations. Based on the antibiogram, the doctor will be able to make an accurate and fast treatment decision for the patient.The first version of this data analysis software has demonstrated the ability of generating MIC and S/I/R determinations in line with the gold standard.

Nanosynex is in parallel dedicating efforts to the development of a disruptive second product module for sample preparation and direct urine testing. It will allow to bypass culturing for urine sample processing, and save an additional diagnostic day, hence enabling AST results in the same day as the urine sample is collected from the patients, as opposed to at least 2-3 days time-to-results using conventional methods. During the first year of the project, significant R&D efforts including consulting key opinion leaders allowed to source relevant components and define an execution plan for development of a prototype alpha

Negotiation with target clinical sites are in place and waiting to be finalized when the system will be ready to be placed in the site. During the first 12 months of the project the team put in-place the core of the quality and regualtory system in order the meet the requirements regarding the formal structuring and documentation of the product development process.

Nanosynex is continuing to develop its relationship with potential commercial partners, to evaluate the competitive landscape, to work to raise the necessary capital for continued platform development and commercialization, and to strengthen its IP position via the filing of additional patents during the first 12 months of the project.

Physical infrastructure, human resources and management capabilities have been expanded over the past 12 months to be in line with the advancement of the company and the tasks that are to be performed in the near future.
The Nanosynex’s game-changing product is based on a unique rapid AST patented technology that delivers AST results in less than 5 hours - or as little as 2 hours for certain bacteria type - which will transforms the market by providing doctors with a tool to receive same-day AST results from clinical isolates (i.e. post-culture), or direct from urine samples for its next generation, guiding them to prescribe accurate, personalised and cost-effective antibiotic treatment, while saving at least one day of hospitalization per patient, hence solving the inconvenience and limitations of current state-of-the art AST solutions and support the fight against AMR.
By the end of the project, Nanosynex will position itself as the leading rapid AST solution for performance improvement in clinical laboratories, andpoint-of-care settings for its next generation.
Consequently, Nanosynex will strongly contribute to significantly reduce the spread of resistant bacteria and the large economic burden associated with AMR.
#4 - Next generation MVP Reader which will handle multiple cards on a fully automated rolling basis
#5 - Summary of NanoSynex Dissemination Efforts through Media Exposure
#3 - NanoSynex first MVP System developed during the first-year program
#1 - Injection Molded NanoSynex first MVP Card with multiple arrays
#2 - NanoSynex first MVP reader