Resource: FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process
Source: U.S. Food and Drug Administration
Synopsis: The U.S. Food and Drug Administration granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1), a diagnostic test for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of COVID-19 and other respiratory tract infections. The diagnostic test, which had an Emergency Use Authorization (EUA), was granted marketing authorization using the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. The grant of this De Novo request marks an important step in FDA’s response to the COVID-19 pandemic because it is the first SARS-CoV-2 diagnostic test that will be permitted to be marketed beyond the public health emergency.The FDA reviewed data from a clinical study of more than 500 test samples and a variety of analytical studies, which demonstrated a reasonable assurance that the BioFire RP2.1 was safe and effective at identification and differentiation of various respiratory viral and bacterial pathogens. With the granting of the De Novo for the BioFire RP2.1 today, the FDA has also revoked the EUA for this device, which was initially authorized for emergency use in May 2020.
The BioFire RP2.1 is for use only in individuals suspected of respiratory tract infections, including COVID-19. This diagnostic test is for the detection and identification of specific viral and bacterial nucleic acids from individuals exhibiting signs and/or symptoms of respiratory infection and aids in the diagnosis of respiratory infection if used along with other clinical and epidemiological information.
Comment: Below is a list of potential pathogens which can be diagnosed with this new technology:
- Adenovirus
- Coronavirus NL63
- Coronavirus OC43
- Human Metapneumovirus
- Influenza A
- Sample Type and Volume Requirements
- Influenza A/H1
- Influenza A/H1-2009 Parainfluenza Virus 1 Parainfluenza Virus 3 Respiratory Syncytial Virus
- Bordetella pertussis
- Mycoplasma pneumoniae
- Coronavirus HKU1
- Influenza A/H3
- Chlamydophila pneumoniae
- Coronavirus 229E
- Influenza B
- Bordetella parapertussis
- Coronavirus SARS-CoV-2
- Parainfluenza Virus 2
- Human Rhinovirus/Enterovirus
- Parainfluenza Virus 4
This is a potential differential diagnostic game changer for the physician in the emergency room, physician office, and or private surgical center.
