DNA NanoSensTB: Diagnostic kit for Mycobacterium tuberculosis markers associated with antibiotic resistance (ABR)
Our product addresses the challenge of diagnosing genetic markers associated with Antibiotic Resistance (ABR) in tuberculosis bacteria, even in low quantities of pathogen cells found in patient sputum samples. Our solution requires only equipment typically found in molecular genetic laboratories. While existing solutions may only confirm the presence of bacteria, they often fail to determine the ABR status. In fact, up to 40% of samples yield inconclusive results, necessitating additional tests, often involving invasive procedures like bronchoscopy. These additional tests not only increase costs but also impose a significant burden on patients. Our test system comprises specially designed tubes containing reaction components, amplification primers, imaging sensors, and multiple internal controls for each step.
Biotechnology And National Health
Technologies for human health
The MVP, medical clearance, and market release - late 2024-early 2025.
During the 2025 the solution will be released to the Russian market. In 2026, after receiving the feedback from clinicians and settling down the production, we will move to India, South Africa, and UAE, and later to China and Philippines.
The test system is developed to be used in diagnostic laboratories instead of existing market options for determining ABR. To perform the analysis, no changes to the instrumentation will be required; the set is available for use with the most commonly presented real-time amplifiers. At the same time, the selectivity of the DNA-sensors used for identifying ABR are superior in comparison to commonly used sensors for real-time. The kit is capable of detecting the presence of the pathogen at a minimum quantity of 10 copies and amplifying fragments carrying genome substitutions linked to ABR against rifampicin and isoniazid. The identification of the pathogen relies on the IS6110 and IprM genes, while ABR to rifampicin is determined using six markers in rpoB (codons 511, 513, 516, 526, 531, and 533). ABR to isoniazid is detected through two markers in katG (codons 315 and 463). Our solution boasts an expected analytical selectivity rate of at least 90%. The key competitive advantage of our test system lies in its robust performance with material present in low concentrations, which is characteristic of M. tuberculosis. Importantly, it eliminates the need for additional devices and does not significantly escalate costs. This achievement is made possible by our utilization of DNA-nanosensors - advanced hybridization probes with heightened selectivity and sensitivity compared to conventional methods.
Acceleration program “Big Intelligence Accelerator” based on Perm National Research Polytechnic University and won the ‘Student startup’ grant of Innovation Promotion Foundation (Fasie)
Gorbenko et al DNA nanomachine for visual detection of structured RNA and double stranded DNA Chem. Commun., 2022,58, 5395-5398; Ateiah et al DNA Nanomachine (DNM) Biplex Assay for Differentiating Bacillus cereus Species IJMS, 2023, 24(5):4473; Rubel et al Detection of Multiplex NASBA RNA Products Using Colorimetric Split G Quadruplex Probes, Methods in molecular biology (Springer), 2023, 2709:287-298
