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bioMérieux Unveils its BIOFIRE® SPOTFIRE® Molecular Testing Solution for the Pharmaceutical Industry, Redefining Rapid Mycoplasma Testing

Marcy-l’Étoile (France), April 9th, 2026 – bioMérieux, a world leader in the field of in vitro diagnostics, announces the launch of BIOFIRE® SPOTFIRE® for pharmaceutical industries, where this innovative molecular testing system is designed to transform quality control. Building on the proven success of the BIOFIRE® FILMARRAY® platform, already adopted by leading global pharmaceutical companies, BIOFIRE® SPOTFIRE® introduces a simple, small and smart approach to mycoplasma detection, helping biopharmaceutical manufacturers strengthen quality control, accelerate decision-making, and protect patients.

Mycoplasma contamination in pharmaceutical production processes can compromise batch quality, cause significant delays and costs, and ultimately impact patient access to life‑saving therapies. Mycoplasmas represent a major and often underestimated threat, capable of inducing profound cellular alterations. Rapid, reliable, and compliant detection of mycoplasmas is therefore essential to help secure bioprocess integrity, prevent cross‑contamination risks, and meet regulatory requirements for cell and gene therapies, vaccines, and biologics.

By delivering robust results in less than 1 hour, BIOFIRE® SPOTFIRE® improves operational efficiency and safeguards manufacturing processes. Its automated workflows, intuitive touchscreen interface and integrated barcode scanning minimize manual steps, reduce human error, and help ensure secure, traceable data - enabling faster decisions and shorter production timelines. Stackable modules save benchtop space and provide scalable capacity to meet evolving manufacturing needs.

Compatible with the existing BIOFIRE® Mycoplasma panel, BIOFIRE® SPOTFIRE® ensures continuity for existing users while elevating solution performance and regulatory compliance. Its design reflects bioMérieux’s commitment to innovation, reliability, and data integrity, helping manufacturers anticipate emerging risks, comply with regulatory requirements, and improve operational indicators.

“BIOFIRE® SPOTFIRE® is more than an instrument: it’s a strategic solution for pharmaceutical manufacturers seeking efficiency, compliance, and peace of mind. By combining speed, simplicity, and robust data integrity, we empower our customers to make faster decisions, minimize downtime, and maintain the highest standards of quality - ultimately benefiting patients worldwide.” stated Yasha Mitrotti, Executive Vice President, Industrial Applications, bioMérieux.

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