- FDA has granted emergency use authorizations to both Labcorp and PerkinElmer for tests able to detect SARS-CoV-2 and influenza A/B simultaneously as laboratories are looking to test for common respiratory illnesses this flu season alongside COVID-19.
- In addition to the three viruses, the so-called "ABC test" (for flu viruses A and B and the coronavirus), PerkinElmer's assay also provides detection and differentiation of respiratory syncytial virus. Labcorp's home collection kit uses a Roche PCR test for use on lab-based cobas 6800/8800 systems. The PerkinElmer PCR panel is for CLIA-certified labs that meet requirements to perform high complexity tests.
- Test makers are gearing up for what is expected to be a severe flu season this year. CDC Director Rochelle Walensky warned Wednesday that Americans may now have reduced immunity against influenza with cases reaching an all-time low last year. Jeff Andrews, vice president of global medical affairs at BD, told MedTech Dive that with COVID-19, flu and RSV circulating in the U.S. population, the country is going to need combination tests to help distinguish these viral infections.
October marks the beginning of the flu season and CDC officials are warning of a possible "twindemic" of COVID-19 and influenza. The problem for healthcare providers are that symptoms alone are not enough to differentiate SARS-CoV-2, flu and RSV infections, which are all highly contagious respiratory illnesses.
"A lot of people are concerned because they don't know if their symptoms are related to COVID or not," BD's Andrews said, who noted the company is ramping up for the surge in combination testing.
BD has a point-of-care antigen test, which received FDA emergency use authorization in March, that can rapidly test for both COVID-19 and influenza at the same time providing results in 15 minutes, as well as a PCR test that can be used in hospital laboratories.
Growth in BD's Integrated Diagnostic Solutions unit was "unfavorably impacted" by the lack of a traditional influenza season in early 2021. However, CEO Tom Polen told investors in May that combination COVID-influenza tests "are going to be important in the next flu season."
CDC has said reduced population immunity due to lack of flu virus activity since March 2020 could result in an early and possibly severe flu season. COVID-19 pandemic mitigation measures last year, such as masking and social distancing, drastically reduced opportunities for the influenza virus to spread.
However, this year's flu season could see a much bigger outbreak in respiratory illness cases with people going back to work, kids returning to school and large gatherings at public events.
"One clue we have is the severity of respiratory syncytial virus right now," said Andrews, who is a practicing physician. "I got another alert in Maryland that RSV is very strong and that's the beginning of the respiratory season as we enter October."
Labcorp's rival Quest Diagnostics also recently launched a new multitarget molecular test service to help detect and differentiate SARS-CoV-2, influenza A, influenza B and RSV viral RNA.