Quidel (QDEL) has now received Emergency Use Authorization (EUA) from the US FDA for its Sofia 2 SARS Antigen FIA, a rapid point-of-care test for suspected COVID-19 infection.
According to the FDA, this is a new category of tests that will now be available for use in the ongoing pandemic. “The antigen diagnostic tests quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs” the FDA says.
One of the main advantages of an antigen test is the speed of the test, which can provide results in minutes. However, antigen tests may not detect all active infections, as they are less sensitive than molecular PCR tests.
This means that negative results from an antigen test may need to be confirmed with a PCR test prior to making treatment decisions or to prevent the possible spread of the virus due to a false negative, the administration added.
Notably, antigen tests can generally be produced at a lower cost than PCR tests, the FDA stated, and once multiple manufacturers enter the market, can potentially scale to test millions of people per day due to their simpler design.
“I am tremendously proud of our organization’s ability to quickly develop and mobilize an accurate rapid antigen test,” said Douglas Bryant, Quidel's CEO. “The EUA for our Sofia 2 SARS Antigen FIA allows us to arm our healthcare workers and first responders with a frontline solution for COVID-19 diagnosis, accelerating the time to diagnosis and potential treatment of COVID-19 for the patient.”
The test is now available for sale in the US and is being shipped to customers.
Shares in Quidel have put on a dramatic rally recently, more than doubling year-to-date. However the stock has a Hold analyst consensus, while the $90 average analyst price target indicates downside potential of over 40%. (See QDEL stock analysis on TipRanks)
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