Beckman Coulter Diagnostics has obtained a European CE mark for the use of its laboratory test designed to distinguish between bacterial and viral infections within 20 minutes.
The Danaher company’s regulatory approval, granted under the European Union’s (EU) in vitro diagnostics regulation (IVDR), validates MeMed’s Access MeMed BV (MMBV) test for use with Beckman’s DxI 9000 and Access 2 immunoassay analysers.
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The EU designation is the latest development in a partnership between Beckman and MeMed, the test’s original developer, which was expanded in May 2024 for Beckman to become the authorised distributor of Access MeMed in the US and Europe. MMBV received US Food and Drug Administration (FDA) approval in 2021.
Bacterial and viral infections commonly present with overlapping symptoms such as fever, cough, fatigue, and sore throat. Early distinction between bacterial and viral can mitigate inappropriate patient management or unnecessary antibiotic use.
Various clinical trials of MMBV have demonstrated the test’s ability to improve clinical decision-making and ensure that appropriate care pathways are taken. MeMed’s test translates the levels of three host proteins – TRAIL, IP-10, and CRP – into a score that indicates the likelihood of bacterial or viral infection. Processed with Beckman’s immunoassay analysers, results can be available within 20 minutes.
The JUNO trial (NCT05762302) demonstrated that MMBV optimised antibiotic prescriptions without increasing emergency care centre visits or hospitalisations in adult patients exhibiting symptoms of lower respiratory tract infection (LRTI).
Melissa Naiman, medical and scientific affairs at Beckman Coulter, commented: “By delivering rapid, highly reliable bacterial and viral differentiation on routine immunoassay systems, we’re empowering care teams with the timely insights they need to guide appropriate treatment decisions, while optimising laboratory efficiency using existing workflows.”
According to real-world studies conducted by MeMed across 6,000 patients, clinicians face uncertainty about antibiotic prescribing in approximately 16–29% of cases. Meanwhile, following receipt of MMBV results, physicians report that the test supported or changed clinical decision-making in 82–87% of cases.
Various analyses of MMBV also highlight the test’s ability to bring cost savings to healthcare institutions. Research on MMBV’s integration in the UK’s National Health Service (NHS) found that the test reduced total NHS costs by £134,018 ($180,000) for adults, and £105,750 for children per 1,000 patients with suspected community-acquired pneumonia (CAP).
According to broader economic data from MeMed, with MMBV now available on Beckman’s install base across Europe, healthcare systems could potentially realise cost savings of up to €80m ($93.5m) in avoidable costs annually due to reductions in unnecessary admissions and diagnostic testing.
