New Pivotal Data Demonstrates Clinical Feasibility of GeneFluidics’ Direct-from-Specimen AST in Clinical Settings

Duarte, CA, November 04, 2022 --(PR.com)-- GeneFluidics, Inc. is pleased to announce a joint publication with the Medical College of Wisconsin (MCW) that introduces rapid antimicrobial susceptibility testing (AST), which would represent a paradigm shift in the clinical management of microbial infections. The data from the MCW study have been published in the Nature Scientific Reports. (https://www.nature.com/articles/s41598-022-21970-2)

AST traditionally requires a 48- to 72-h turn-around; this window of time can be critical for some antimicrobial therapeutic interventions. In this joint publication, GeneFluidics’ clinical partners demonstrate the clinical validation of the GeneFluidics’ direct-from-specimen PCR-less AST platform that reduces the time between patient sampling and lab results. Currently, there is no FDA-cleared direct-from-specimen AST testing and the biggest challenge of performing AST directly from unprocessed clinical specimens with an unknown microbial load is aligning the categorical susceptibility report with CLSI reference methods required by the FDA, which start from a fixed bacterial concentration (inoculum of 0.5 McFarland units) prepared using pure colonies from an overnight sub-culture. In this pilot clinical feasibility study using de-identified remnant specimens collected from MCW, we received and tested the high and low ends of microbial loads as expected in clinical settings, demonstrating a final categorical agreement of 100% for ciprofloxacin and 100% for sulfamethoxazole-trimethoprim.

Research reported in this publication was supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Number RO1AI117059 and the Eunice Kennedy Shriver National Institute of Child Health & Human Development of the National Institutes of Health under Award Number R44HD084033. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

The complete publication is available for free on The Nature Scientific Reports’ website (https://www.nature.com/articles/s41598-022-21970-2).

About GeneFluidics
GeneFluidics was incorporated in 2000 to develop a fast, accurate, and simple testing system for improving worldwide healthcare. By integrating novel molecular analysis and lab automation technologies, the company’s revolutionary platform enables complex tests that are normally performed only by skilled technicians in a laboratory to be performed by anyone, anywhere. GeneFluidics is committed to improving the quality of human life with advanced engineering and molecular analysis technologies.

For more information on GeneFluidics, contact:
Vincent Gau
Email: info@genefluidics.com