Beckman Coulter Diagnostics, a Danaher Corporation subsidiary, secured the CE 2797 mark for its Access MeMed BV assay on April 13 2026. The host‑response test measures the proteins TRAIL, IP‑10 and CRP to distinguish bacterial from viral infections in about 20 minutes on existing Beckman Coulter DxI 9000 and Access 2 immunoassay analyzers.
The approval extends Beckman Coulter’s diagnostic portfolio into core laboratory settings across Europe, allowing laboratories to use their current equipment for rapid infection differentiation. By providing a quick, reliable test, the assay supports antimicrobial stewardship initiatives and could generate up to €80 million in cost savings for European health systems, according to modeling estimates.
Danaher’s Q1 2026 earnings, released on January 28 2026, showed revenue of $6.838 billion—up 4.6% year‑over‑year—and earnings per share of $2.23, beating the consensus estimate of $2.19. The diagnostics segment, which includes Beckman Coulter, contributed significantly to the company’s high‑margin recurring‑revenue profile. The acquisition of Masimo Corporation in February 2026 is expected to further strengthen Danaher’s diagnostics franchise.
"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 optimizing laboratory efficiency using existing workflows," said Melissa Naiman, Medical & Scientific Affairs, Beckman Coulter Diagnostics. "This collaboration with Beckman Coulter significantly accelerates our mission to make host‑response testing available at scale," added Eran Eden, CEO and co‑founder of MeMed.
The Access MeMed BV assay builds on a technology that received FDA approval in 2021 and now meets the In‑Vitro Diagnostic Regulation (IVDR) requirements for the European market. Its host‑response approach offers a distinct advantage over traditional pathogen‑based tests, and the ability to run on high‑throughput analyzers positions it competitively within the infectious disease diagnostics landscape.
The CE mark signals a key milestone for Beckman Coulter and Danaher, expanding their reach in European core laboratories and reinforcing the company’s focus on high‑margin, recurring‑revenue diagnostics solutions. The product’s rapid turnaround and integration into existing workflows are expected to drive adoption and support broader antimicrobial stewardship efforts across the region.
The content on EveryTicker is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.