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A Spanish SME has developed and patented a device for the analysis of genetic sequences that allows fast, reliable and selective identification of nucleic acids without performing either electrophoresis or sequencing assays, reducing both analysis duration and economic cost. The SME is looking for manufacturers capable of producing the device on a larger scale.
At present, both nucleic acid detection and quantification play an essential role in medicine, veterinary science, microbiology, pharmacology or toxicology, being decisive in the diagnosis, control, monitoring and treatment of numerous pathologies. Current biochemical and culture-based techniques have low sensitivity, reliability and accuracy and take too long to provide conclusive results. That is the reason why today molecular techniques are widely used, even though most of them require additional verification by sequencing analysis for definitive confirmation of presumptive positive results (presence of a polymerase chain reaction - PCR- product that matches the expected size after an electrophoresis assay). In any case, these techniques entail a high expenditure on equipment, reagents, consumables, service outsourcing, sample storage and transportation and the time needed to obtain and interpret analytical results, all of which greatly increases the cost of testing.
A Spanish SME dedicated to developing cutting-edge products in the field of molecular diagnostics and with broad expertise in biotechnology and molecular biology has developed a proprietary state-of-the-art device, which allows specific capture and detection of genetic sequences.
The technology of the device is based on scientifically-proven molecular principles and on the use of super fluorescent and metastable molecules for robust detection of specific DNA sequences and genetic diagnosis. This allows for fast, reliable and selective identification of nucleic acids without performing neither electrophoresis nor sequencing assays, which reduces both analysis duration and its economic cost. Moreover, it is possible to accurately quantifying the DNA concentration of a sample in a few minutes, verifying the purity and integrity of said sample, and maintaining high sensitivity and affordable costs in comparison to current alternatives. In summary, the technology can be used to perform several nucleic-acid-based tests:
• Analytical and diagnostic PCR reading
• Analysis of genetic markers associated to clinically-relevant microorganisms and specific phenotypic traits
• Genotyping tests (detection of synthetic molecular barcodes, genetic profiling and characterization…)
• Quantitative and expression analysis
The analysis device is a portable multimodular gadget with different functional units integrated in an innovative design that allows for the optimization of the entire analytical process. Each of these modules focuses on specific activities of the experimental procedure and can be programmed to perform different functions both together and separately through a general control interface.
The SME is looking for manufacturing agreement for producing the device on a larger scale. As a result of the intended collaboration, the SME expects to associate with a partner capable of gradually achieving a broad implementation of the technology in an international market. Accomplishing this will allow for a progressive development of new analytical applications based on said platform, thus diversifying the product portfolio and maximizing market value.
• Significant reduction in costs per test due to the use of a faster and more efficient technology that allows for multiple samples to be analyzed simultaneously without performing electrophoresis assays or purifying and sequencing amplified fragments.
• Major reduction in equipment costs in comparison with current alternatives for performing electrophoresis and sequencing assays.
• Reduction of analysis duration (going from days to hours) and indirect saving due to the optimization of sample storage and transportation and to the execution of the analysis without service outsourcing.
• Additional reduction in analysis duration due to the supply of ready-to-use reaction mixtures, the high degree of automation of the analytical process and the provision of test results which can be easily interpreted.
• Increase in the reliability of the test, since it is a sequence-based assay whose molecular design makes it possible to maintain a high sensitivity while improving the remarkable specificity of PCR-based tests.
• Integration of the technology in all kinds of processes and in reverse-transcription PCR analysis, distinction between dead and infection-causing pathogens, multiplex PCR, simultaneous detection of various pathogens, real-time PCR or quantitative determination of the stage of an infectious process.
• Adaptation to the user’s specific needs for the customized design of analytical tests and their scientific validation and experimental optimization, as well as for quality assurance through full-time technical assistance.
Manufacturers with experience in producing diagnostic devices and/or medical devices.
In order to reach collaboration agreements, the SME is seeking strategic partners such as pharmaceutical/biotech companies or companies with medical devices in their product portfolio that operate on a large scale in sectors in which the technology can be used.
The SME expects a partner capable of producing the device on a larger scale and thus gradually achieving a broad implementation of the technology in an international market.