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Miniaturized Matrixed Enthalpy Metter - Portable, affordable, easy to operate, diagnostic device enabling a rapid & accurate diagnosis of a patient infected by antibiotic-resistant bacteria

Periodic Reporting for period 1 - MMEM (Miniaturized Matrixed Enthalpy Metter - Portable, affordable, easy to operate, diagnostic device enabling a rapid & accurate diagnosis of a patient infected by antibiotic-resistant bacteria)

Reporting period: 2019-07-01 to 2020-06-30

The European Food and Safety Authority and the ECDC report that antibiotic-resistant bacteria cause 33,000 death/year in the EU alone. This alarming number continuously grows and is forecasted to reach 10 million death/year by 2050. The main threat arises from Carbapenemase Producing Enterobacteriaceae (CPE), which have developed resistance to all kinds of known antibiotics. Infections occur across the continent, and no effective antibiotics are within reach. GenoSmart develops a novel bio-electronic molecular detection system, for detecting the presence of pathogenic DNA obtained from patients. In contrast to all currently available molecular detection techniques, GenoSmart MMEM device fulfills the critical need for rapid, accurate, self-contained diagnosis tool, providing cost-effective test, with no need for any external facility. The sample-to-result diagnostic process will be seamless with no human contact, and will yield clear and simple results in less than 30 minutes.
GenoSmart's ultimate goal is to render the MMEM ready for market launch in Europe. This entails a number of technical and strategic objectives, including the completion of the product’s CPE detection capability, the clinical validation through a European clinical study, and exploitation of the results.
During the first year of this project GenoSmart developed an automatic machine and process for isolating DNA from a sample, termed Automatic Nucleic Acid Extractor (ANAE). The process begins by inserting a sample into a perishable, contamination free cartridge. Next, the cartridge is introduced into the ANAE machine and the DNA is isolated from the sample automatically with no human contact. The produced DNA is injected into the MEM for detection of CPE genes. The system will perform all the functions necessary for detecting the presence of CPE species automatically and will report simple and clear results. A comprehensive bioinformatics survey for optimizing relevant oligonucleotides sequences for detecting the most CPE genes prevalent in Europe was performed. Regulation and validating steps are in process.
During the second year of the project, the extracting unit (ANAE) and the diagnostic machine (MEM) will be combined to produce a rapid, cost-effective, easy-to-use diagnostic sample-to-result MMEM machine. The efficacy of the sample-to-result process will be validated and tested in-house with a model-bacteria and at a clinical test site using clinical samples.
Being cost-effective, rapid, accurate and easier to use in on-site scenarios – one-by-one and all together – will lead to significant impact on the market and bring important benefit to humankind, starting in Europe and expanding world-wide. These parameters are critical factors in controlling the devastating effects of the antibiotic resistant bacteria pandemic, which may jeopardize treatment of patients’ who need procedures such as surgery, cancer treatment, child birth and more.
We plan to disseminate GenoSmart’s MMEM sample-to-result device in clinical laboratories, emergency rooms, doctor offices and other point-of-care locations. The most important parameters in the fight against rapidly spreading pandemics such as CPE, COVID-19 and others, are accurate, efficient, affordable, and timely diagnosis. The business potential stems from the urgent need for a prompt screening technology that would combine swiftness, accuracy, and a cost-effective detection method. GenoSmart’s solution will result in significant increase of diagnostic tests and will enable better management of the disease prevalence and spread in the population, in a cost-effective manner. The recent COVID-19 pandemic demonstrates the urgent need for GenoSmart’s rapid and affordable diagnostic solution, which can be readily adapted to any new and emerging pathological threat.
GenoSmart's Miniature Enthalpy Meter (MEM)