Validex System: The First 5-Minute Molecular Diagnostic Testing Solution
The Validex System is a transformative molecular diagnostic testing solution for POC settings.
|Rapid||Sample-to-result in less than 5 minutes, regardless of target concentration in sample.|
|Accurate||PCR levels of sensitivity with the accuracy of central laboratory-based MDx testing.|
|Easy to Use||Single-step workflow on crude clinical samples, designed for CLIA-waived settings.|
|Syndromic Panels||High multiplexing capacity (10’s of targets) provides clinically relevant information.|
|Scalable Throughput||Enables molecular testing from point-of-care to high volume laboratory settings.|
|Affordability||Low-cost disposable assay cartridge and instrument, minimal maintenance cost.|
The Validex System is a completely novel approach to molecular testing which eliminates the limitations of current PCR-based molecular testing systems. The robust molecular amplification chemistry and waveguide detection technology that is incorporated into our Validex System:
- Requires no polymerases, primers, NTPs or dNTPs
- Works in crude clinical samples (no sample processing)
- Eliminates the need for thermal cycling
- Requires no microfluidics, pumps or mechanized valves
The Validex System utilizes a novel Coupled Hairpin Amplification System (CHASE) enabled by a novel thermophilic nuclease 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 in an extremely rapid exponential amplification.
Labeled oligonucleotides 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.
Clinical Samples Performance
Validex System Advantages
The Validex System will enable a broad spectrum of molecular diagnostic testing from simple screening assays to more complex syndromic panel testing and quantitative viral load assays. Product development is rapid and predictable due to our ability to employ programmatic and algorithm-based bioinformatics into the design of the synthetic hairpin molecules used in our CHASE amplification chemistry. The Validex System facilitates the development of rapid, easy to use and affordable assays that can be deployed in point-of-care settings.