BD Expands BD MAX™ System Menu with New IVDR-Certified VIASURE Assays in Partnership with Certest Biotec
Rhea-AI Summary
BD (NYSE: BDX) on Dec 15, 2025 announced IVDR certification in Europe for two VIASURE assays developed by Certest Biotec for the BD MAX™ System. The certified assays are the VIASURE Respiratory Virus Extended Mix (detects SARS-CoV-2, flu A/B, RSV, parainfluenza, human coronavirus, metapneumovirus, adenovirus from one nasopharyngeal swab) and the VIASURE HSV-1, HSV-2 & Treponema pallidum assay (detects HSV-1, HSV-2 and Treponema pallidum from anogenital and oral lesion swabs).
The announcement expands BD MAX molecular respiratory and STI testing options in Europe; the BD MAX System runs up to 24 samples per run, automates extraction/amplification/detection, and delivers results in ~three hours with <1 minute hands-on time per sample.
Positive
- IVDR certification obtained for two VIASURE assays in Europe
- Adds a multi-pathogen respiratory panel covering SARS-CoV-2, flu A/B, RSV and more
- Adds an STI panel detecting HSV-1, HSV-2 and Treponema pallidum
- BD MAX throughput: processes up to 24 samples per run; results in ~3 hours
Negative
- None.
Key Figures
Market Reality Check
Peers on Argus
BDX gained 0.23% while key peers were mixed: ALC down 0.04%, RMD down 0.76%, WST and BAX up 1.45% each, HOLX up 0.21%, suggesting a stock-specific move rather than a broad sector shift.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 04 | Safety testing partnership | Positive | +0.1% | Collaboration with ChemoGLO to expand hazardous drug contamination testing. |
| Dec 03 | Product launch | Positive | +1.6% | New BD FACSDiscover A8 analyzer configurations for broader lab access. |
| Nov 24 | Product launch Europe | Positive | -0.9% | European rollout of BD Surgiphor surgical wound irrigation system. |
| Nov 18 | Automation partnership | Positive | +0.7% | Pharmacy automation collaboration using BD Rowa Vmax with Henry Ford Health. |
| Nov 17 | Board appointments | Positive | +0.7% | Addition of two directors bringing health care and digital expertise. |
BD news has mostly seen modest positive price alignment, with one notable divergence on a European product launch.
Over the past months, BD has focused on partnerships and product innovation, including hazardous drug contamination testing with ChemoGLO, new BD FACSDiscover A8 cell analyzer configurations, and the European launch of the BD Surgiphor™ wound irrigation system. It also advanced automation via a pharmacy partnership with Henry Ford Health and refreshed its board on Dec. 1, 2025. The new BD MAX™ and Certest Biotec assay expansion fits this pattern of broadening clinical solutions, especially in diagnostics.
Market Pulse Summary
This announcement expands the BD MAX™ System menu with IVDR-certified VIASURE assays for respiratory viruses and STI pathogens, reinforcing BD’s strategy of broadening its automated diagnostics platform. Recent history shows similar moves in automation, safety testing, and European product launches. Investors may track adoption of the new assays, ongoing partnership activity, and how these menu additions support utilization of BD MAX™ across European clinical laboratories.
Key Terms
in vitro diagnostic medical device regulation regulatory
ivdr regulatory
AI-generated analysis. Not financial advice.
The newly certified assays include:
- VIASURE Respiratory Virus Extended Mix Real Time PCR Detection Kit for BD MAX™ System:
Detects multiple respiratory viruses, including SARS-CoV-2, flu (A and B), RSV, parainfluenza, human coronavirus, metapneumovirus, and adenovirus, from a single nasopharyngeal swab. - VIASURE HSV-1, HSV-2 & Treponema pallidum Assay for BD MAX™ System:
Identifies the presence of herpes simplex viruses (HSV-1 and HSV-2) and the bacteria that causes syphilis (Treponema pallidum) using anogenital and oral skin lesion swabs.
"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
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 visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/, X (formerly Twitter) @BDandCo or 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 Materials under the Alaset brand, Immunodiagnostics (Rapid Tests, Turbidimetry, and CLIA), and Molecular Biology (PCR and NGS) under the VIASURE brand 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 McLoughlin | Adam Reiffe Vice President, Investor Relations 201.847.6927 |
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SOURCE BD (Becton, Dickinson and Company)
FAQ
What did BD (BDX) announce on December 15, 2025 about the BD MAX System?
Which pathogens does the VIASURE Respiratory Virus Extended Mix for BD MAX detect?
What sample types does the VIASURE HSV-1, HSV-2 & Treponema pallidum assay for BD MAX accept?
How long does the BD MAX System take to deliver results and how many samples per run?
How does the Certest Biotec partnership affect BD MAX assay availability in Europe?
