Beckman Coulter secures CE mark for bacterial-viral differentiator test

Beckman Coulter has received a CE mark to run MeMed's Access MeMed BV (MMBV) test on its DxI 9000 and Access 2 analysers, with results available in about 20 minutes; clinical trials reported the test can help optimise antibiotic prescribing without increasing emergency visits or hospitalisations.

Beckman Coulter Diagnostics has obtained a European CE mark for the use of MeMed's Access MeMed BV (MMBV) test on its DxI 9000 and Access 2 immunoassay analysers. The approval was granted under the EU's in vitro diagnostics regulation (IVDR). The MMBV test translates levels of three host proteins into a score that indicates the likelihood of bacterial or viral infection and can produce results in about 20 minutes. Clinical trials and real-world studies cited in the announcement reported effects on antibiotic prescribing and potential cost savings. Key facts: - The CE mark validates MMBV for use on Beckman Coulter's DxI 9000 and Access 2 analysers under the EU IVDR. - MMBV measures three host proteins (TRAIL, IP-10, CRP) and converts them into a bacterial-versus-viral likelihood score, with results processed in about 20 minutes on routine immunoassay systems. - The JUNO trial (NCT05762302) reported that MMBV optimised antibiotic prescriptions for adults with lower respiratory tract infection without increasing emergency visits or hospitalisations. - MeMed's real-world studies across about 6,000 patients reported clinician uncertainty about antibiotic prescribing in roughly 16–29% of cases, and that test results supported or changed clinical decisions in 82–87% of cases. - Economic analyses cited include NHS modelling that found reduced total costs per 1,000 patients with suspected community-acquired pneumonia, and MeMed's estimate that wider availability on Beckman's installed base could reduce avoidable costs across Europe by up to €80 million annually. - The CE mark follows a partnership expansion between Beckman and MeMed; MMBV previously received US FDA approval in 2021 and Beckman became an authorised distributor in the US and Europe in 2024. Summary: The CE marking allows Beckman Coulter to offer MeMed's MMBV test on its analysers across Europe, potentially expanding laboratory access to a rapid bacterial-versus-viral differentiator that has been associated with changes in prescribing and possible cost reductions. Undetermined at this time.