Australian company Microbio says it has received clearance from UK authorities for the sale of its InfectID-BSI bloodstream infection test in the country.
The clearance is in the form of a United Kingdom Conformity Assessed) marking.
InfectID-BSI is an in vitro diagnostic test that aims to improve patient outcomes by alerting clinicians within three hours of taking a blood sample for which infection to treat.
“The high sensitivity and ability to use a diagnostic test to rule out infections has a considerable clinical impact, one that differentiates it greatly from other tests that have previously entered the market,” said Christopher Brain, the managing partner of UK-based medical technology company YouMed.
“Not only is InfectID-BSI unique to the market, it also outperforms the current gold standard diagnostic test that is the standard of care in most every hospital for sepsis and bloodstream infection management.”
Microbio’s chief scientific officer and co-founder Dr Flavia Huygens said InfectID-BSI test has the potential to advance the detection of bloodstream infections and sepsis.
“We are excited to receive the UKCA marking for our InfectID-BSI test, moving us another step closer to providing this powerful diagnostic tool to clinicians across the globe,” said Dr Huygens.
“With the test already cleared for sale and use in Europe and now the UK, we are working towards approvals of InfectID-BSI across South America and in the Caribbean.”