NEW YORK – The US Centers for Disease Control and Prevention has designed a new assay that can simultaneously detect the SARS-CoV-2 coronavirus and the influenza virus, and is seeking Emergency Use Authorization for it from the US Food and Drug Administration, CDC Director Robert Redfield told a congressional subcommittee on Thursday.
In prepared remarks for a hearing before the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, Redfield said that it is unclear how long the COVID-19 pandemic will last but that "COVID-19 activity will continue for some time." Similarly, the impact the pandemic will have on the upcoming flu season is unclear, but "if there is substantial COVID-19 and seasonal influenza activity at the same time, this could place a tremendous burden on the healthcare system and result in many illnesses, hospitalizations, and deaths."
Many predict that a second wave of coronavirus cases could hit in the fall during the start of the flu season.
In preparation for such a scenario, the CDC is seeking EUA from the FDA for a new assay that can simultaneously detect SARS-CoV-2 and influenza, as "determining if influenza or SARS-CoV-2 is causing the infection is also important to clinical treatment, infection control, and community mitigation efforts," Redfield said.
As of Thursday afternoon, there were almost 1.9 million cases of COVID-19 confirmed in the US and nearly 109,000 deaths from the disease.
A couple of diagnostic panels that test for COVID-19 and influenza already exist in the US. For example, a PCR-based respiratory panel from BioMérieux's BioFire Diagnostics business that can detect the coronavirus and 20 other viral and bacterial respiratory pathogens, including various influenza A subtypes, received FDA EUA in early May. Also, an RT-PCR-based respiratory panel from Qiagen that includes SARS-CoV-2 and 20 other viral and bacterial pathogens, including influenza A and B types, obtained FDA EUA in March.
An assay from CDC was the first test to be granted EUA from the FDA for SARS-CoV-2. Problems quickly arose with the test, however, when some labs reported problems with the reagents and could not implement the test.
The CDC did not immediately respond to a request for comment on the new test.