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Fast and reliable molecular analysis device and method which guarantee affordable costs in comparison with current genetic tests

Country of Origin: Spain
Reference Number: TOES20190904002
Publication Date: 9 September 2019

Summary

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 neither electrophoresis nor sequencing assays, reducing both analysis duration and economic cost. The SME is looking for strategic partners interested in licensing or acquiring their technology along with technical support.

Description

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 and has a broad range of application fields:

• Basic research: Qualitative and/or quantitative analysis of genetic sequences
• Plant and animal health: Pathogen, soil and toxicity analysis, livestock management, genotyping.
• Human health: Forensic analysis, diagnosis and monitoring of diseases, epidemics control, genetic screening.
• Environmental sector: Microbiological and toxicological analysis in different matrices
• Agri-food sector: Microbiological food testing, genetically modified organism (GMO) identification.

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 patented technology can be used to perform all kinds of 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 molecular analysis device is a 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 strategic partners interested in a licensing agreement or a commercial agreement with technical support. As a result of the intended collaboration, the SME expects to associate with a partner capable of gradually achieving a broad implementation of their technology in an international market. Accomplishing this will allow for a progressive development of new analytical applications based on said platform.
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Advantages and Innovations

•	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.

Stage Of Development

Prototype available for demonstration

Stage Of Development Comment

Working prototype ready for demonstration (see pictures)

Requested partner

Commercial agreement with technical assistance: 
The SME is seeking strategic partners such as pharmaceutical / biotech companies or big distributors that operate on a large scale in sectors in which the technology can be used. These partners should be able to efficiently supply a wide range of end users: veterinary clinics, health centers, clinical, forensic and analysis laboratories, etc. The company can offer these kind of partners a production deal (by which they would be entirely responsible for manufacturing and selling the technology). The SME would sustain a close collaboration with the partners, providing permanent assistance with starting up installations and staff training, as well as complete consulting services regarding technical and scientific matters, quality control and customer relations.

License agreements:
The SME also contemplates a different kind of partnership, by which a large company with sufficient resources would acquire the property rights over the technology in order to further develop and commercialize it on its own. In addition to this, the company is willing to reach particular licensing agreements involving specific locations and trade sectors.

Cooperation offer ist closed for requests