Respiratory Diagnostic Panels Received New EU Certification
New regulatory status for these respiratory infection tests will soon expand their availability in European hospitals.
Updated on Sept. 22, 2026 in Diseases — General
Live Poll
Do you believe faster diagnostic testing for high-risk pathogens improves your own access to healthcare?
bioMérieux has secured Class D certification under the European Union's In Vitro Diagnostic Regulation for its BIOFIRE respiratory panels. These tools, which identify common respiratory pathogens, are scheduled for release across the European market by early 2027.
Why it matters
The Class D designation is the highest risk classification for diagnostic devices, highlighting the critical role these tests play in managing pathogens that pose significant public health threats. By standardizing these tools, officials aim to improve the accuracy and speed of identifying respiratory infections.
bioMérieux received Class D certification for its BIOFIRE Respiratory 2.1 plus and BIOFIRE FILMARRAY Pneumonia plus panels, a designation reserved for devices that detect high-risk pathogens. This certification recognizes the utility of these panels in managing public health.
The players
bioMérieux
A global diagnostic company that develops in vitro diagnostic solutions to improve patient outcomes and public health.
The details
The BIOFIRE panels utilize syndromic testing to detect a range of viral and bacterial pathogens, as well as markers for antimicrobial resistance, from a single patient sample. The Respiratory 2.1 plus panel provides results for upper respiratory infections in approximately 45 minutes, while the FILMARRAY Pneumonia plus panel analyzes lower respiratory tract infections in about one hour. No changes were made to the product design or intended clinical purpose to achieve this certification.
Timeline
September 22, 2026: bioMérieux announced the IVDR Class D certification for the diagnostic panels.
Early 2027: The certified panels will become available on the European market.
Health Landscape
This certification reflects the ongoing implementation of the European Union's In Vitro Diagnostic Regulation, which mandates stricter safety and performance standards for medical diagnostics. The inclusion of MERS-CoV on these test menus confirms their role in addressing high-risk public health priorities.
While these diagnostic panels are intended for hospital and laboratory use, faster testing capabilities may result in quicker care decisions for patients with respiratory symptoms. If you have concerns about the speed of diagnostic testing during an acute respiratory illness, speak with your physician.
The takeaway
These diagnostic panels help clinicians identify complex respiratory infections in under an hour by testing for multiple pathogens simultaneously. Patients who frequently deal with respiratory issues can ask their doctor about how rapid molecular diagnostics might affect their treatment planning.
Further reading
For more information on diagnostic advancements, visit Diseases — General.
Source note: This article includes information reported by Selectscience.
Live Poll
Do you believe faster diagnostic testing for high-risk pathogens improves your own access to healthcare?
