SelectScience
Join Free
NewsClinical Diagnostics

bioMérieux receives IVDR CE marking for two BIOFIRE SPOTFIRE Panels

bioMérieux

The certification includes conformity assessment for near-patient testing, enabling its use outside traditional laboratories, directly at the point of care

20 Mar 2026

Product news

bioMérieux has announced that its BIOFIRE® SPOTFIRE® Respiratory/Sore Throat plus (R/STplus) Panel and BIOFIRE® SPOTFIRE® Respiratory/Sore Throat plus (R/STplus) Panel Mini have been CE-marked under the In Vitro Diagnostic Regulation.

The certification includes conformity assessment for near-patient testing, enabling its use outside traditional laboratories, directly at the point of care. These multiplex PCR tests can simultaneously detect the most common pathogens responsible for respiratory and sore throat infections, within a timeframe aligned with a typical patient visit.

Compatible with the compact innovative BIOFIRE® SPOTFIRE® System, the BIOFIRE® SPOTFIRE® R/STplus Panel and the BIOFIRE® SPOTFIRE® R/STplus Panel Mini are unique multiplex PCR tests capable of identifying nucleic acids for the most common bacteria, viruses, and viral subtypes responsible for respiratory or sore throat infections, in about 15 minutes.

The BIOFIRE® SPOTFIRE® R/STplus Panel detects 15 pathogens and the BIOFIRE® SPOTFIRE® R/STplus Panel Mini detects up to 6 pathogens, including human Rhinovirus/Enterovirus, Strep A, Flu A/B, RSV and SARS-CoV-2. Together, these assays deliver a flexible and tailored solution that empowers clinicians to choose the right test on a single streamlined platform that combines clinical flexibility with operational simplicity.

The BIOFIRE® SPOTFIRE® R/STplus Panel is intended to replace the previously commercialized BIOFIRE® SPOTFIRE® R/ST Panel, which was CE-marked under the In Vitro Diagnostic Directive, as the product transitions to its new registration under IVDR. In addition, bioMérieux is introducing the BIOFIRE® SPOTFIRE® R/STplus Panel Mini, further strengthening its dynamic and contextual respiratory testing approach in Europe.

Samples may be collected using either a nasopharyngeal or a throat swab, depending on the suspected infection. The BIOFIRE® SPOTFIRE® R/STplus Panel Mini also offers a third sampling method with anterior nasal swab specifically for use with the respiratory menu. Flexibility in sample types facilitates testing in non-traditional locations.

“The IVDR CE-marking certification of these two R/ST panels is an important milestone for bioMérieux ― strengthening our ability to support healthcare professionals with flexible, cost-effective point-of-care testing solutions across Europe. With proven commercial performance and a rapidly expanding menu, BIOFIRE® SPOTFIRE® is a testament of bioMérieux’s leadership and commitment to diagnostic innovation for improved patient outcomes,” said Jennifer Zinn, Executive Vice President, Clinical Operations, bioMérieux.

Want the latest science news straight to your inbox? Become a SelectScience member for free today>>

Links

bioMérieuxCompany website

Tags

Clinical MicrobiologyMicrobiology is the study of microorganisms including protists, prokaryotes, fungi, and, often, viruses. Microorganisms are a useful research tool as genetic vectors and, in immunology, for antibiotic susceptibility testing, cellular biology and genetics. Microorganisms commonly grow readily in incubators with microbial culture media; this can contain chromogenic supplements to differentiate between cell lines. Estimate your culture’s density of microorganisms with colony counters, or screen and select colonies for desirable clones with automated colony pickers. Additionally, equipment is available to monitor environments for the presence of microbes and identify with microbial identification instruments. Find the best microbiology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Respiratory InfectionsRespiratory infections are caused by pathogens such as bacteria, viruses, and fungi, leading to diseases like pneumonia, tuberculosis, and COVID-19. It is important to identify respiratory infections quickly in patients to ensure appropriate treatment and care, and to prevent sepsis. Browse our peer-reviewed product directory to find the best tools for respiratory infection detection, compare products, check reviews, and get pricing directly from manufacturers.Covid-19COVID-19, caused by the SARS-CoV-2 virus, has led to a global health crisis with profound impacts on societies and economies. Research into diagnostics, vaccines, treatments, and understanding viral mechanisms continues to evolve. The pandemic has accelerated innovations in healthcare and biopharmaceuticals, including novel vaccine platforms and rapid testing technologies. Browse our peer-reviewed product directory to find top COVID-19 testing kits, research tools, vaccines, and treatments, compare products, read reviews, and receive direct pricing from manufacturers.StreptococcusPoint of Care SolutionsPoint of care solutions provide medical diagnostics and treatments at or near the site of patient care. These technologies offer rapid results, helping healthcare providers make quick decisions. From glucose monitors to molecular diagnostics, point of care solutions are transforming healthcare delivery by reducing wait times and improving patient outcomes. Explore the best point of care products in our peer-reviewed product directory, compare options, check reviews, and get pricing directly from manufacturers.

Related articles