Our Technology
Rapid AST: Find the right treatment
Once the pathogen is known, the next step is to identify the treatment. Currently, physicians are often limited to starting patients on the most likely antibiotic before complete laboratory tests can confirm which treatment will work. This process requires full laboratory equipment and 3-4 days.
GeneCapture’s automated phenotypic process detects pathogen growth in the presence of various antibiotic drugs and concentrations to provide a quick actionable susceptibility test, identifying which drug is effective in 90 minutes. The FDA pre-submission is complete for a Urinary Tract Infection indication.
Rapid ID: Identify the pathogen(s)
Starting with urine, swab, or blood samples, GeneCapture can identify pathogen(s) in 60 minutes. This portable platform requires no refrigeration, no laboratory, and no special medical training.
The cartridge, which is the heart of the platform, has a large library of pathogen probes. We have the capability to test up to 200 pathogens, including for unknown ‘Pathogen X’ threats. The microarray houses custom probes from our library designed to report the presence of single or mixed pathogens from a variety of sample types. The platform can identify bacteria, viruses, fungus and parasites. New probes can be added in just a few days.
The probes are based on the sequence of the pathogen, so they are highly specific and sensitive. The FDA pre-submission for Urinary Tract Infection is complete, which included a review of the on-site and on-cartridge built-in QC for ease of operations. Future submissions will follow for other disease states.
How does the CAPTURE Rapid ID Platform work?
Confirming Active Pathogens Through Unamplified RNA Expression, (CAPTURE™) is a technology that we invented to automate an affordable and quick solution for Point of Care Pathogen detection. The platform is built to function independent of a lab, accept various samples matrices, test for hundreds of pathogens and provide on-cartridge sample prep - a universal solution for Point of Care applications.
Over 5000 tests have been run in our lab to develop this technique which is designed to deliver 98% specificity and 98% sensitivity. After identification, an Antibiotic Susceptibility Test can be accomplished with a second cartridge using growth media and pathogen counts in control or antibiotic wells.
See the short video for a simplified animation of the direct RNA hybridization method.
Rapid ID: The magic is in the cartridge
We decided from the very beginning that the disposable cartridge needed to accept a variety of samples, detect a variety of pathogens, and be quick and very affordable. It’s a marvel - this cartridge does all the heavy lifting; the sample prep, the molecular prep the biochemistry and the result, all in under an hour. It’s 95% less time than the current standard.
A microarray of pathogen-matching probes identify the pathogen(s). The inset of green spots is an actual image taken from a test. The pattern instantly reveals which pathogen is present, and reports the answer to the user.
Process overview for our two platforms
Current Product Status
Operating Rapid Pathogen ID prototypes.
Operating manufacturable-quality cartridge.
Probes designed and tested for over 30 pathogens.
FDA pre-submission complete for Urinary Tract Infection indication; preparing for clinical tests I 2027.
Multiple performance validations completed and published.
Quality System established.
Critical vendors and supply chain established.
Lab bench Rapid Antibiotic Susceptibility Test platform validated with multiple antibiotics
AST cartridge design underway.
8 patents awarded and or filed and multiple trade secrets.