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
12-Channel ECG
CM1200B
Resorbable Bovine Collagen Membrane
GenDerm
Glucose Meter
StatStrip®
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 Tool Uses Mammograms to Detect Common Cardiovascular Diseases
Cardiovascular disease, encompassing hypertension, ischemic heart disease, and stroke, is the leading cause of death in women. Many cases are detected late, as symptoms can be subtle and routine screening... Read more
AI Tool Predicts Post-Heart Attack Trajectories to Personalize Follow-Up
Acute myocardial infarction (heart attack) survivors often develop new comorbidities and complications that unfold over years. Predicting which patients will deteriorate and where problems will arise remains... Read more
Critical Care
view channel
Wearable Hormone Monitor Enables At-Home Detection of Primary Aldosteronism
Primary aldosteronism, a hormone disorder that affects up to one in five people with hypertension, increases risks of heart disease, stroke and diabetes. Many cases are missed because routine testing is... Read more
Contactless AI Tool Detects Hypertension and Diabetes from Facial Video
Hypertension and diabetes are widespread yet often undiagnosed, driving preventable cardiovascular morbidity and mortality. Screening typically depends on clinic visits or wearable devices, which can limit... Read more
Surgical Techniques
view channel
Biodegradable Gastric Stent Could Eliminate Repeat Procedures After Bariatric Surgery
Gastric leaks are a serious complication after weight-loss surgery that can lead to infection, prolonged hospitalization, and repeated interventions. Conventional drainage stents were designed for the... Read more
Robot-Assisted Surgery Shows Advantages Over Laparoscopy in Gastric Cancer
Gastric cancer is most often treated with surgery, yet minimally invasive techniques can be technically challenging. Laparoscopic gastrectomy reduces recovery time compared with open surgery but relies... Read more
Patient Care
view channel
Multicenter Study Quantifies Delays in Care for Emergency Department Boarders
Emergency department (ED) boarding—the practice of keeping admitted patients in the ED while awaiting an inpatient bed—creates hazardous delays in definitive care. Prolonged transitions expose older and... Read more
Real-Time Radiation Monitor Supports Safer Fluoroscopy-Guided Procedures
Fluoroscopy-guided procedures expose clinicians to scatter radiation that accumulates over time, creating persistent occupational risks in cath labs and interventional suites. Traditional badges typically... Read more
Medical Imaging
view channel
Study Links Thymus Radiation Dose to Poorer Outcomes in Lung Cancer
Collateral radiation to the thymus during therapy for non-small cell lung cancer (NSCLC) may compromise antitumor immunity and disease control. The thymus is a small immune organ in the upper chest that... Read more
Automated AI Tool Enables Uncertainty-Aware Meningioma Volume Tracking on MRI
Magnetic resonance imaging (MRI) guides diagnosis and monitoring in brain tumors, yet routine measurements often rely on subjective reads or simplified two-dimensional calculations. These methods can miss... Read more
Health IT
view channel
Imaging Tool Quantifies Calcinosis Cutis Volume to Monitor Treatment
Calcinosis cutis involves calcium deposits in the skin or soft tissues that can develop anywhere in the body, causing pain, impaired mobility, and disability. Lesions along the spine or buttocks can make... Read more
Digital Symptom Monitoring Supports More Personalized Breast Cancer Care
Metastatic breast cancer, in which tumors spread to other organs, is incurable but increasingly managed with modern systemic therapies. As more treatments shift from hospital infusions to oral or at-home... Read more
Point of Care
view channel
Microneedle Patch Enables At-Home Monitoring of Acute Kidney Injury
Kidney disease is often silent in its early stages, making timely detection difficult outside clinical settings. Early biomarkers such as neutrophil gelatinase–associated lipocalin can require blood draws... Read more
Ultrathin Metasurface Could Bring Quantitative Phase Imaging to Portable Devices
Point-of-care imaging often depends on bulky optical systems that have difficulty visualizing nearly transparent cells and tissues without staining. These limitations can slow diagnosis and restrict use... Read more
Business
view channel
Philips and Imricor Collaboration Advances MRI-Guided Cardiac Procedures
Cardiac arrhythmias affect millions of people worldwide and are often treated with catheter ablation. These procedures typically rely on X-ray fluoroscopy, which provides only indirect visualization of... Read more
Abbott LAA Occluder Gains CE Mark for AFib Stroke Risk Reduction
Atrial fibrillation increases stroke risk because blood clots often form in the left atrial appendage. For patients who cannot tolerate long-term anticoagulation, minimally invasive closure can provide... Read more
FDA Seeks Feedback on Regulating Generative AI Medical Devices
Generative artificial intelligence (AI) is rapidly entering clinical workflows, offering tools that could enhance patient care while introducing risks that differ from those of traditional software.... Read more