6th September 2013 Content supplied by:
Pathogenica Achieves CE Marking for HAI BioDetection Kit
Pathogenica, Inc. has achieved CE marking for its HAI BioDetection kit that runs on the Ion PGMâ„˘ benchtop sequencer. This milestone marks the HAI BioDetection CE-IVD kit as the first sequence-based infectious disease diagnostic kit on the market.
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.
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.
â€śCulture independent sequencing is a great step forward for clinical applications,â€ť said Pathogenica co-founder George Church, Prof. of Genetics at Harvard Medical School. â€śPathogenica has delivered a next-generation sequencing diagnostic tool that provides identification and antibiotic resistance information for improved infection control and therapeutic decision making.â€ť
â€śThought leaders in infection control departments have been enthusiastic about our rapid high resolution test,â€ť said Adesokan. â€śPathogenica 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.â€ť
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.
Date Published: 6th September 2013