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A Stronger Business Relationship to Enhance bioMérieux’s BIOFIRE® SPOTFIRE® Presence in the US Outpatient Diagnostic Market

bioMérieux has strengthened its relationship with McKesson Medical-Surgical, a diversified healthcare services leader dedicated to advancing health outcomes for patients everywhere. McKesson Medical-Surgical will be the exclusive distributor of the FDA-cleared & CLIA-Waived BIOFIRE® SPOTFIRE® Respiratory Solution in the U.S., driving bioMérieux’s expansion into the decentralized, near patient in vitro diagnostics (IVD) market.


bioMérieux’s newly FDA-cleared point-of-care solution, the BIOFIRE® SPOTFIRE® system will now be available from McKesson Medical-Surgical in the United States for the outpatient market starting November 14, 2023.

McKesson Medical-Surgical is an established market leader across multiple non-acute settings, providing supplies and solutions for a variety of health systems. McKesson Medical-Surgical's strong presence in the outpatient space, supported by a robust sales team of primary care account executives and a comprehensive expert team of diagnostic focused sales consultants, allows bioMérieux the opportunity to exponentially increase their reach into the previously untapped non-acute segment.

The latest advancement in PCR infectious disease diagnostics

The COVID-19 pandemic has reiterated the need for healthcare professionals to have diagnostic tests available as close as possible to the patient, providing actionable results quickly. The need is even greater in the United States where the outpatient market is mature and dynamic.

In order to best serve this clinical need, in 2023 bioMérieux launched its BIOFIRE® SPOTFIRE® System, the latest enhancement in PCR infectious disease diagnostics. This small, scalable, multiplex PCR platform is designed to bring central laboratory diagnostic results to the decentralized point-of-care (POC) clinical setting. It can be used by any healthcare professional in any CLIA-waived healthcare setting.

The BIOFIRE® SPOTFIRE® System is the first FDA-cleared PCR system to provide results in under 20 minutes! The instrument is designed to run the BIOFIRE® SPOTFIRE® Respiratory Panel and BIOFIRE® SPOTFIRE® Respiratory Panel Mini, which detect 15 and 5 of the most common respiratory pathogens during a patient’s visit in about 15 minutes, respectively. Both panels are FDA-cleared and CLIA-waved.

“Partnering with such a strong distributor immensely expands the reach of where we do business, and we are eager to work with their dedicated team of experts. McKesson Medical-Surgical will help us give even more providers access to our innovative and cutting-edge technology, and we anticipate the major impact this partnership may have on how decentralized CLIA-waived healthcare settings work with their patients.”

Colin Hill, Head of Clinical Operations – North America, bioMérieux