BD has broadened the menu of its BD MAX™ System, a fully automated molecular diagnostic platform that processes up to 24 samples per run in roughly three hours, by adding two new VIASURE assays that carry In‑Vitro Diagnostic Medical Device Regulation (IVDR) certification. The first assay, VIASURE Respiratory Virus Extended Mix, expands the platform’s respiratory panel to include a wider array of viral targets, while the second, VIASURE HSV‑1, HSV‑2 & Treponema pallidum Assay, adds rapid detection of two common sexually transmitted infections. Both assays are supplied by Certest Biotec, a partner that has worked with BD since 2017 and has steadily increased its IVDR‑certified portfolio.
The IVDR certification is a significant regulatory milestone, as the EU’s new framework imposes stricter safety, performance, and traceability requirements than the previous directive. By securing IVDR approval for these assays, BD removes a major barrier to market entry in the European Union, where compliance is mandatory for all in‑vitro diagnostics. The partnership with Certest Biotec, which has a long history of developing PCR‑based tests, demonstrates BD’s strategy of leveraging external expertise to accelerate product development and regulatory clearance.
The respiratory and STI markets represent substantial opportunities. In 2024, global demand for rapid respiratory testing was estimated at $3.5 billion, with a projected CAGR of 6% through 2030, while the STI testing market was valued at $1.2 billion and is expected to grow at 5% annually. By adding these assays, BD positions the BD MAX™ System to capture a larger share of these high‑growth segments, especially in laboratories that require a single, fully automated solution for both respiratory and STI testing. Competitors such as Thermo Fisher Scientific, Abbott Laboratories, and Hologic offer similar platforms, but BD’s expanded panel gives it a broader diagnostic footprint and a potential competitive edge in multi‑test laboratories.
BD’s Q3 FY2025 results provide context for the strategic value of this expansion. The company reported revenue of $5.5 billion and an adjusted diluted EPS of $3.68, a 4% increase from the prior quarter and a 12% rise year‑over‑year. Management highlighted that incremental sales from new assay introductions are expected to contribute to future revenue growth, aligning with BD’s focus on high‑margin, recurring‑revenue products. While the announcement does not disclose specific projections for the new assays, the incremental sales are anticipated to reinforce the platform’s market appeal and support BD’s broader strategy of expanding its automated diagnostics portfolio.
In the competitive landscape, BD’s expanded BD MAX™ System now competes more directly with Thermo Fisher’s QuantStudio and Abbott’s Alinity m platforms, both of which offer extensive respiratory and STI panels. By adding IVDR‑certified assays, BD can offer a more comprehensive solution that may reduce the need for laboratories to purchase multiple instruments, potentially increasing customer lock‑in and cross‑sell opportunities. The move also signals BD’s commitment to maintaining a differentiated product line in a market where regulatory compliance and assay breadth are key differentiators.
BD’s senior vice president of diagnostics, Dr. Maria Sanchez, emphasized the company’s dedication to regulatory excellence and market expansion. “Securing IVDR certification for these assays confirms our commitment to delivering reliable, high‑quality diagnostics across the EU,” she said. “By expanding the BD MAX™ System’s capabilities, we are better positioned to meet the evolving needs of laboratories and ultimately improve patient outcomes.”
The announcement underscores BD’s strategy of leveraging strategic partnerships and regulatory achievements to drive growth in its core diagnostics business.
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