Investigational point-of-care platform from Detect generates rapid laboratory-quality molecular results, company says
Detect Inc. announced promising pre-clinical results for its molecular vaginitis assay, demonstrating over 95% agreement with an existing FDA-approved test and delivering results within 20 minutes on a user-friendly platform.
Detect Inc. has shared results of a pre-clinical study testing the performance of its investigational molecular vaginitis assay.
The study evaluated 171 clinical specimens, comparing Detect's molecular vaginitis assay with an FDA-cleared molecular vaginitis test. Detect’s assay demonstrated greater than 95% overall agreement with the comparator. The company’s proprietary point-of-care platform also achieved a 99% valid test rate while delivering results within 20 minutes.
Detect's prototype molecular testing platform is being developed for use in physician offices and other point-of-care settings. The platform combines automated sample processing with a minimal hands-on workflow to deliver high-performance molecular testing and rapid, accurate diagnosis. The investigational vaginitis assay is the first to be developed for Detect's portfolio of rapid diagnostics that will run on its platform.
Detect’s proprietary TruLAMP isothermal amplification technology powers the company’s platform by incorporating a novel enzyme designed to enhance the sensitivity, specificity and speed of conventional LAMP chemistry. By delivering high-performance molecular detection without complex thermal cycling, TruLAMP enables simplified instrumentation and streamlined workflows while maintaining the accuracy required for molecular diagnostic testing. This flexible chemistry will enable menu expansion for a broad set of future assays on a single platform.
