Microbio expects said it expects clinical evaluation trials of its InfectID-BSI tests to be completed next month, prior to launching in the European market.
US-based Landrich Group is managing the trials at four locations in the US, South America, India and Australia, undertaking a performance evaluation of Microbio InfectID assays.
Landrich Group CEO Tina Landess said the company was delighted to be involved at this critical stage of Microbio’s Design and Development Plan.
“We are excited to participate in the innovative approach of Microbio to upgrade the blood culture methodology when treating patients suspected of blood infection,” said Ms Landess.
The study is designed to determine the efficacy of the Microbio InfectID-BSI bacterial and yeast detection assay in a clinical laboratory environment using remnant samples as well as contrived samples for pathogen detection and identification versus the gold standard assay of blood culture.
One of the clinicians selected by the Landrich Group to conduct the trials is Professor Alan Wu from the University of California San Francisco (UCSF), who is chief of the clinical chemistry and toxicology laboratories at San Francisco General Hospital.
Ms Landess said the UCSF is an experienced investigational site that has conducted nearly a dozen studies with the Landrich Group. Professor Wu’s team is expected to complete its work to meet the May deadline.
Microbio CEO Dr Flavia Huygens said the company was confident to submit its InfectID-BSI tests to such rigorous assessment by scientists of the calibre of Professor Wu and was delighted that the Landrich Group had agreed to manage the clinical evaluation.
“We are excited by the results our own trials have provided and we are looking forward to receiving independent validation from the experts assembled by Landrich Group,” said Dr Huygens.
The current ‘gold standard’ method to identify the causative pathogen is a slow, two-step blood culturing and identification process that takes between 12 hours and several days and has limited sensitivity.
Microbio said its InfectID-BSI provides the potential for early BSI/sepsis diagnosis and therefore earlier use of optimal antimicrobials, which is likely to reduce the length of hospital stays and healthcare costs. The diagnostic test identifies 26 common BSI/sepsis-causing pathogens, using Real-Time Polymerase Chain Reaction (RT-PCR) instruments, which are open hardware platforms used in pathology labs around the world.