BioMérieux BIOFIRE Respiratory 2.1 (RP2.1) Panel with SARS-CoV-2 Becomes First COVID-19 Diagnostic Test to Obtain De Novo FDA Authorization
|
By HospiMedica International staff writers Posted on 19 Mar 2021 |
|
Image: BIOFIRE RP2.1 Panel (Photo courtesy of BioMérieux)
BioMérieux (Marcy-l'Étoile, France) has received US Food and Drug Administration (FDA) De Novo authorization for the BIOFIRE RP2.1 Panel, making it the first SARS-CoV-2 diagnostic test of any kind to be granted De Novo status by US FDA.
The panel allows for the detection of 22 viral and bacterial pathogens responsible for respiratory infections, including SARS-CoV-2 (the cause of COVID-19 disease). The panel was granted De Novo status by US FDA after having gone through the normal US FDA review pathway outside of the Emergency Use Authorization (EUA) track. The De Novo authorization will be concurrent with the revocation of the US FDA EUA that was obtained on May 1, 2020 for the panel. The BIOFIRE RP2.1 Panel EUA and De Novo kits are identical with the exception of changes to the labeling.
The BIOFIRE RP2.1 Panel allows healthcare providers to quickly identify common respiratory pathogens found in patients presenting with acute respiratory tract infection, using one simple test. The BIOFIRE RP2.1 Panel yields results in approximately 45 minutes using nasopharyngeal swab (NPS) samples in transport media or saline. It runs on the fully automated BIOFIRE FILMARRAY 2.0 and BIOFIRE Torch Systems with only two minutes of sample preparation time.
The De Novo application was supported by a multicenter prospective clinical study in which the performance of the BIOFIRE RP2.1 Panel SARS-CoV-2 assay was evaluated in over 500 specimens against a combined reference of three independent molecular SARS-CoV-2 assays, each with U.S. FDA EUA designation. The BIOFIRE RP2.1 Panel SARS-CoV-2 assay demonstrated positive percent agreement (PPA) of 98.4% and negative percent agreement (NPA) of 98.9%.
“The De Novo authorization of the BIOFIRE RP2.1 Panel demonstrates how BioFire is dedicated to responding to a rapidly-evolving global pandemic with urgency and accuracy. This is the first US FDA De Novo authorized COVID-19 test,” said Pierre Boulud, Chief Operating Officer, Clinical Operations of bioMérieux.
Related Links:
BioMérieux
The panel allows for the detection of 22 viral and bacterial pathogens responsible for respiratory infections, including SARS-CoV-2 (the cause of COVID-19 disease). The panel was granted De Novo status by US FDA after having gone through the normal US FDA review pathway outside of the Emergency Use Authorization (EUA) track. The De Novo authorization will be concurrent with the revocation of the US FDA EUA that was obtained on May 1, 2020 for the panel. The BIOFIRE RP2.1 Panel EUA and De Novo kits are identical with the exception of changes to the labeling.
The BIOFIRE RP2.1 Panel allows healthcare providers to quickly identify common respiratory pathogens found in patients presenting with acute respiratory tract infection, using one simple test. The BIOFIRE RP2.1 Panel yields results in approximately 45 minutes using nasopharyngeal swab (NPS) samples in transport media or saline. It runs on the fully automated BIOFIRE FILMARRAY 2.0 and BIOFIRE Torch Systems with only two minutes of sample preparation time.
The De Novo application was supported by a multicenter prospective clinical study in which the performance of the BIOFIRE RP2.1 Panel SARS-CoV-2 assay was evaluated in over 500 specimens against a combined reference of three independent molecular SARS-CoV-2 assays, each with U.S. FDA EUA designation. The BIOFIRE RP2.1 Panel SARS-CoV-2 assay demonstrated positive percent agreement (PPA) of 98.4% and negative percent agreement (NPA) of 98.9%.
“The De Novo authorization of the BIOFIRE RP2.1 Panel demonstrates how BioFire is dedicated to responding to a rapidly-evolving global pandemic with urgency and accuracy. This is the first US FDA De Novo authorized COVID-19 test,” said Pierre Boulud, Chief Operating Officer, Clinical Operations of bioMérieux.
Related Links:
BioMérieux
Gold Member
SARS‑CoV‑2/Flu A/Flu B/RSV Sample-To-Answer Test
SARS‑CoV‑2/Flu A/Flu B/RSV Cartridge (CE-IVD)
Gold Member
STI Test
Vivalytic Sexually Transmitted Infection (STI) Array
New
Radiofrequency Generator
GX1
New
X-Ray Generator
Advantage Plus Generators
Latest COVID-19 News
- Low-Cost System Detects SARS-CoV-2 Virus in Hospital Air Using High-Tech Bubbles
- World's First Inhalable COVID-19 Vaccine Approved in China
- COVID-19 Vaccine Patch Fights SARS-CoV-2 Variants Better than Needles
- Blood Viscosity Testing Can Predict Risk of Death in Hospitalized COVID-19 Patients
- ‘Covid Computer’ Uses AI to Detect COVID-19 from Chest CT Scans
- MRI Lung-Imaging Technique Shows Cause of Long-COVID Symptoms
- Chest CT Scans of COVID-19 Patients Could Help Distinguish Between SARS-CoV-2 Variants
- Specialized MRI Detects Lung Abnormalities in Non-Hospitalized Long COVID Patients
- AI Algorithm Identifies Hospitalized Patients at Highest Risk of Dying From COVID-19
- Sweat Sensor Detects Key Biomarkers That Provide Early Warning of COVID-19 and Flu
- Study Assesses Impact of COVID-19 on Ventilation/Perfusion Scintigraphy
- CT Imaging Study Finds Vaccination Reduces Risk of COVID-19 Associated Pulmonary Embolism
- Third Day in Hospital a ‘Tipping Point’ in Severity of COVID-19 Pneumonia
- Longer Interval Between COVID-19 Vaccines Generates Up to Nine Times as Many Antibodies
- AI Model for Monitoring COVID-19 Predicts Mortality Within First 30 Days of Admission
- AI Predicts COVID Prognosis at Near-Expert Level Based Off CT Scans
Channels
Artificial Intelligence
view channel
AI Model Uses Eye Imaging to Identify Risk of Major Systemic Diseases
Early detection of systemic disease risk remains a persistent challenge in population health screening. Cardiometabolic conditions such as diabetes, heart disease, and stroke often progress without symptoms... Read more
AI Platform Interprets Real-Time Wearable Data for Parkinson’s Management
Parkinson’s disease presents fluctuating motor and non-motor symptoms that complicate day-to-day self-management and clinical decision-making. Care teams require timely, longitudinal insight into medication... Read more
Critical Care
view channel
Graphene-Based Material Selectively Eliminates Bacteria While Sparing Human Cells
Drug-resistant bacterial infections continue to complicate wound management and device-associated care, where persistent contamination raises morbidity and costs. Safer, fabric‑integrated antimicrobials... Read more
Dried Platelet Biologic Reduces Hemorrhage After Traumatic Brain Injury
Traumatic brain injury (TBI) triggers immediate intracranial bleeding and days-later cerebral edema that can rapidly worsen neurological injury. Effective drug options to curb these processes are limited,... Read more
Wearable Cardiac Monitor with Cellular Transmission Enhances Remote Arrhythmia Detection
Remote cardiac monitoring requires comfort, wearability, and adherence to gather electrocardiogram data for clinical review. Mailing devices back for data processing can delay review. Faster insights,... Read more
Surgical Techniques
view channel
Torqueable Microcatheters Enhance Navigation in Complex Coronary Lesions
Interventional cardiologists frequently encounter tortuous vessels and heavily calcified or fibrotic coronary lesions that complicate guidewire control and device delivery. Stable, predictable torque and... Read more
Transcatheter Venous Arterialization Improves Outcomes in No-Option Limb Ischemia Patients
Chronic limb-threatening ischemia (CLTI) is an advanced stage of peripheral artery disease in which plaque narrows leg arteries and severely restricts blood flow, leading to pain, nonhealing wounds, and... Read more
Patient Care
view channel
Wearable Sleep Data Predict Adherence to Pulmonary Rehabilitation
Chronic obstructive pulmonary disease (COPD) is a long-term lung disorder that makes breathing difficult and often disturbs sleep, reducing energy for daily activities. Limited engagement in pulmonary... Read more
Revolutionary Automatic IV-Line Flushing Device to Enhance Infusion Care
More than 80% of in-hospital patients receive intravenous (IV) therapy. Every dose of IV medicine delivered in a small volume (<250 mL) infusion bag should be followed by subsequent flushing to ensure... Read more
Health IT
view channel
AI System Detects and Quantifies Chronic Subdural Hematoma
Viz.ai (San Francisco, CA, USA) announced a strategic commercialization collaboration with Johnson & Johnson (New Brunswick, NJ, USA) to expand access in the United States to the Viz Subdural solution... Read more
Continuous Monitoring Platform Detects Infection Risk Across Care Transitions
Patients leaving skilled nursing facilities often lose continuous physiologic monitoring, increasing the risk of undetected infection and delayed intervention. Nursing home residents are seven times more... Read more
Automated System Classifies and Tracks Cardiogenic Shock Across Hospital Settings
Cardiogenic shock remains a difficult, time-sensitive emergency, with delayed identification driving poor outcomes and persistently high mortality. Many cases go undocumented even at advanced stages, hindering... Read more
Point of Care
view channel
Business
view channel
Johnson & Johnson Launches AI-Driven Cardiac Mapping System
Johnson & Johnson has introduced the CARTOSOUND SONATA Module for the CARTO System at the Heart Rhythm Society (HRS) 2026 meeting in Chicago. The module uses artificial intelligence with the CARTO... Read more
