This is a novel molecular platform that enables point-of-care visual and modular detection of nucleic acids. It has been clinically validated and shown to perform well against a clinical gold standard test (Cobas® HPV) with a high detection accuracy of area under the curve = 0.965 for HPV16 and area under the curve = 0.944 for HPV18. Furthermore, by expanding the intra-subtype coverage, it is able to detect infections in samples that were missed by the commercial test.
The system consists of an integrated and configurable circuit of enzyme-DNA nanostructures, which function as independent recognition and signaling elements, for direct and expandable detection of diverse pathogen nucleic acids from infected cells.The built-in enzymatic cascades produce a rapid and enhanced colour readout for the naked eye. The enhanced visual detection not only improved the clinical inter-subtype differentiation, but also expanded the intra-subtype coverage to identify previously undetectable infections.
Initially targeting the markets for diagnosis and screening of infectious diseases.
Additional markets can be pursued wherever detection of specific nucleic acids is required:
The nucleic acid market is expected to grow beyond US$4,900 million by end of 2027 with a compound annual growth of 7.5% from 2017-2027. Current detection of pathogen nucleic acids is performed in the centralized clinical laboratories. This is costly, time-consuming and requires trained personnel. Therefore, there is a need for easy-to-use point-of-care diagnostics.