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BD Expands BD MAX™ System Menu with New IVDR-Certified VIASURE Assays in Partnership with Certest Biotec

Key Takeaway: BD has announced the expansion of its BD MAX™ System with two new IVDR-certified VIASURE assays developed in partnership with Certest Biotec. This addition enhances the system's diagnostic capabilities for respiratory and sexually transmitted infections in Europe. The BD MAX™ System offers a fully automated molecular platform that processes up to 24 samples per run, providing timely results to support clinical decision-making.
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POSITIVE FACTORS

  • Expansion of BD MAX™ System with new assays enhances diagnostic capabilities.
  • Partnership with Certest Biotec strengthens BD's product offerings.
  • New assays support faster and more accurate detection of infections.

Full Press Release Details

FRANKLIN LAKES, N.J.,Dec. 15, 2025/PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE:BDX), a leading global medical technology company, today announced the expansion of its respiratory and sexually transmitted infection (STI) diagnostics offerings in Europe following In Vitro Diagnostic Medical Device Regulation (IVDR) certification of two VIASURE assays developed by Certest Biotec for use on the BD MAX™ System. The addition of these new assays to the BD MAX™ System portfolio enables clinical laboratories to detect a broad range of pathogens quickly and accurately using a fully automated molecular platform.
The newly certified assays include:
The newly certified assays include:
"With these two assays, we are adding clinically relevant, targeted molecular panels to our already broad respiratory and STI menu," said Philippe Villiard, vice president, BD Diagnostic Solutions in Europe. "Our partnership with Certest Biotec has been instrumental in expanding the BD MAX™ System menu and supports our commitment to delivering innovative diagnostic solutions that enable faster, more comprehensive detection of infectious diseases on the BD MAX™ System."
The BD MAX™ System can process up to 24 samples per run and offers a comprehensive assay menu spanning HAI, respiratory, enteric, STI and women's health panels, as well as offering open system capabilities. Designed for clinical laboratories and hospitals, the BD MAX™ System combines real-time PCR technology with automated nucleic acid extraction, amplification and detection in a single streamlined workflow. It delivers results in approximately three hours with less than one minute of hands-on time per sample, providing clinicians with timely, reliable information to support accurate treatment decisions and helping improve patient care.
"Our partnership with BD, which began in 2017, continues to grow and we are excited to strengthen our collaboration once again. We are confident that our joint efforts will result in exceptional projects in the future," affirmed Certest's CEO Nelson Fernandes.

About BD

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its more than 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visitbd.comor connect with us on LinkedIn atwww.linkedin.com/company/bd1/, X (formerly Twitter)@BDandCoor Instagram@becton_dickinson

About Certest

Certest Biotec is a European company established in 2002 for the development, manufacturing and commercialization of in vitro diagnostic medical devices. Today, Certest is a global company structured around four business areas:Raw Materialsunder theAlasetbrand,Immunodiagnostics(Rapid Tests, Turbidimetry, and CLIA), and Molecular Biology(PCR and NGS) under theVIASUREbrand as well as Pharma. Offering one of the widest portfolios in human in vitro diagnostics and pharma, the company builds its future on strong technical knowledge and deep expertise in the detection of human diseases. Certest's next generation laboratories, state-of-the-art equipment and highly skilled professionals are the foundation for delivering reliable, high-quality solutions  to medical diagnostic professionals.

Contacts:
Media Investors
Fallon McLoughlinDirector, Public Relations201.258.0361[email protected] Adam ReiffeVice President, Investor Relations201.847.6927[email protected]

Frequently Asked Questions

What is the BD MAX™ System?

The BD MAX™ System is a fully automated molecular platform for detecting various pathogens.

What new assays were added to the BD MAX™ System?

Two new IVDR-certified VIASURE assays for respiratory and STI diagnostics were added.

Who is Certest Biotec?

Certest Biotec is a European company specializing in in vitro diagnostic medical devices.

How many samples can the BD MAX™ System process?

The BD MAX™ System can process up to 24 samples per run.

What is the significance of IVDR certification?

IVDR certification ensures that the assays meet European regulatory standards for medical devices.

Last updated: Dec 15, 2025