BOSTON, Aug. 14, 2013 /PRNewswire/ -- Pathogenica, Inc. (www.pathogenica.com) announced today that the company has achieved the CE mark under the European Directive on In Vitro Diagnostic Medical Devices for its HAI BioDetection kit that runs on the Ion PGM™ benchtop sequencer. This milestone marks the HAI BioDetection CE-IVD kit as the first sequence-based infectious disease diagnostic kit on the market.
"The kit and interpretation software system provides clinicians with a revolutionary diagnostic tool for the identification of disease-causing bacteria and accompanying antibiotic resistance markers in a clinically actionable timeframe," said Yemi Adesokan, Pathogenica's CEO. "Our team is proud to be supporting the evolving way healthcare providers will routinely manage patient care and treatment options."
Healthcare associated infections (HAIs) are recognized as a severe health threat associated with increases in cost, morbidity, and mortality. Although screening has enabled reductions in some facilities' MRSA infection rates, recent lethal outbreaks of antibiotic resistant Acinetobacter, Enterococcus, Klebsiella, and Pseudomonas emphasize the diversity of organisms that threaten patient health. Intensive care units (ICUs) and other hospital wards with patients particularly susceptible to infection may benefit from advanced screening measures.
The HAI BioDetection CE-IVD kit enables identification of the causative agents of 95% of nosocomial infections in a single assay, enabling clinicians t
|SOURCE Pathogenica, Inc.|
Copyright©2012 PR Newswire.
All rights reserved