We believe our technology will provide a novel approach to molecular diagnostics free of limitations found in current systems.
Our technology simplifies the complexities of assay development:
- No polymerases or primers
- No NTPs or dNTPs
- No processing steps (inclusive of purification, washes and reagent additions)
- No microfluidics, pumps or mechanized valves
- No target amplicon containment challenges
Our solution is built around a simple but very powerful proprietary chemistry and an innovative low-cost reader. In recent studies, reaction product has been generated in just a few minutes and detected within seconds. Our proprietary DNS enzyme has roots in genomics while our reader system is powered by a robust waveguide technology that uses low-cost optical components borrowed from the smartphone industry. We believe that this technology could revolutionize how, when and where molecular diagnostics can be used.
The Validex System utilizes a novel Coupled Hairpin Amplification System (CHASE) enabled by a novel thermophilic nuclease (DSN enzyme) that works directly in crude clinical specimens and digests DNA and DNA:RNA hybrid duplexes with SNP level specificity. Nucleic acid targets from the sample hybridize to complementary synthetic hairpin molecules that are subsequently digested by the nuclease and release fluorescently labeled, single-stranded oligonucleotides (Fluorescent Reporters) in an extremely rapid exponential amplification.
Labeled oligonucleotides (fluorescent reporter stems) released from the CHASE exponential amplification reaction flow across a plastic waveguide array in a simple passive flow channel where they are captured and imaged on its surface after excitation by an evanescent wave applied to the system through a proprietary lens. Detection of captured oligonucleotide reporter molecules on the waveguide surface is almost instantaneous with a positive real time signal emerging in less than 30 seconds.