The past two years have seen a relatively quiet flu season as hospitals and the public health system focus on managing waves of COVID-19. Flu is expected to make a comeback this winter and people will need to distinguish between the two illnesses.
The FDA is being asked by at- home testing companies to authorize combination tests that can detect both COVID-19 and flu in a single sample. In May, the agency was asked to sign off on the dual test by the company. The combination test made by Labcorp requires people to take a saliva sample and mail it to the lab.
It would be helpful to have a fast way to distinguish flu from COVID-19. After someone starts to feel unwell, they need to be given anti-viral medication. The wait to get a positive flu test can make something like Tamiflu less effective.
The president and CEO of Lucira Health said in a statement that they believe delivering a highly accurate at- home test for both COVID-19 and flu can greatly improve access to appropriate therapeutic options in the window of time when they are most effective.
The companies make at- home tests that look for bits of viral genetic material. They are more accurate than at- home tests, but they are more expensive. It is not accessible to many people due to the high cost of the reader and tests.
When other options aren't available, the FDA allows it to clear tests more quickly when emergency use authorization is requested. New types of tests might allow them to get that sign-off. The FDA said in September that it would ask most new COVID-19 tests to go through the normal regulatory pathway, but carved out an exception for tests that fill an unmet need. That bar would be met by an at- home rapid combination test.
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