Pathogenica, Inc. 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 to rapidly take appropriate precautions for specific patients. The assay not only identifies the pathogen but also includes a broad panel of 10 resistance genes (including mecA, vanA, KPC and TEM), enhancing a clinician's ability to choose the appropriate antimicrobial therapy and practice proper antibiotic stewardship. Studies have shown active surveillance to be a valuable component of a quality infection control program that enhances treatment decisions, improves patient care, and reduces costs due to extended length of stay, unnecessary isolation, and nursing time.
The HAI BioDetection CE-IVD kit prepares samples for sequencing from DNA extracted from isolates, colonies, positive blood culture, urine, rectal swabs, and stool. This broad array of sample types makes Pathogenica's assay a strong fit for identifying pathogens associated with enteric diseases, bloodstream infections and respiratory disorders – the key profile for HAIs in the US and EU. Furthermore, the assay requires no pre-culturing for urine, rectal swabs, and stool, enabling a streamlined lab workflow and clinically actionable turnaround (12 hours from DNA extraction to results) for patients affected by urinary tract infections or enteric disorders.
"Culture independent sequencing is a great step forward for clinical applications," said Pathogenica co-founder George Church, Prof. of Genetics at Harvard Medical School. "Pathogenica has delivered a next-generation sequencing diagnostic tool that provides identification and antibiotic resistance information for improved infection control and therapeutic decision making."
"Thought leaders in infection control departments have been enthusiastic about our rapid high resolution test," said Adesokan. "Pathogenica produces clinically superior and actionable results more rapidly after sample collection than other technologies such as MALDI-TOF and PFGE, which require pre-cultured samples."
In validation testing, the HAI BioDetection CE-IVD kit demonstrated a 100% correct identification rate for 771 bacterial samples. From specific clinical specimens, the kit identified 100% of Enterococcus positive rectal swabs, with an 89% detection rate of vanA, and achieved 92% concordance with microbial culture from stool for a broad set of bacterial targets.