• BSI test under evaluation for European Market

News & Views

BSI test under evaluation for European Market

Apr 26 2022

Following positive domestic pilot study results for its flagship bloodstream infection (BSI) test, Australian company Microbio has appointed US clinical research consultants the Landrich Group to manage clinical evaluation trials across four sites in the USA, India, South America and Australia, with plans to submit the data generated to secure marketing clearance in Europe, India, USA and Australia.

A capital raise to fund clinical evaluation and operational costs preceded the mid-year launch of the Brisbane company’s invitro diagnostic test into the European market; its availability to India, USA, Australia and a number of Asian markets was expected to follow, said the company.

Microbio CEO Paul Carboon said the introduction of the test was keenly anticipated: “It has been 16 years in development and thanks to the support of key investors and tireless work by our scientific and administrative team we are within weeks of going to market which is a major milestone for the company. We are also delighted to have appointed WG Partners as our corporate advisors for what will be our last capital raise before we are in the market and generating income.”

WG Partners will provide Microbio with a range of advisory services to help the company deliver on its ambitions over the next few years. “The track record of London based healthcare specialist investment bank WG Partners speaks for itself having completed transactions with a total value of £8.2 billion (A$144 billion) in the past 10 years,” he added.

InfectID-BSI is said to provide the potential for early BSI/sepsis diagnosis within 3 hours rather than the current standard two-step blood culturing and identification process that can take longer than 12 hours. It 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. “We are excited that commercialisation is now imminent and that we are a step closer to providing this powerful diagnostic tool to clinicians across the globe.” Mr Carboon said.

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