Pathogenica has received the CE mark for its HAI BioDetection kit that runs on the Ion PGM benchtop sequencer.
HAI BioDetection CE-IVD kit is a qualitative in vitro test designed for the rapid identification of bacterial organisms and resistance genes for improved infection control and therapeutic decision making.
It is reportedly the first sequence-based infectious disease diagnostic kit available in the market.
Pathogenica CEO Yemi Adesokan noted the kit and interpretation software system provides clinicians with a new diagnostic tool for the identification of disease-causing bacteria and accompanying antibiotic resistance markers in a clinically actionable timeframe.
"Our team is proud to be supporting the evolving way healthcare providers will routinely manage patient care and treatment options," Adesokan added.
The comprehensive single assay enables identification of the causative agents of 95% of nosocomial infections and a broad panel of 10 resistance genes, allowing clinicians to rapidly take appropriate precautions for specific patients.
The HAI BioDetection CE-IVD assay can be performed on DNA samples extracted from isolates, colonies, positive blood culture, urine, rectal swabs, and stool.
The streamlined lab workflow made possible by culture independent sequencing and a clinically actionable turnaround time of 12 hours makes the new assay a valuable diagnostic tool for improving infection control and therapeutic decision making.
Also, the HAI BioDetection CE-IVD kit demonstrated a 100% correct identification rate for 771 bacterial samples in validation testing.