A Look at the FDA’s Most Recent COVID-19 Approval

OraSure Technologies Inc. (NASDAQ: OSUR) shares jumped to start off the week after the company announced an update from the U.S. Food and Drug Administration (FDA) in regards to its COVID-19 test kit.

Specifically, the firm announced that its DNA Genotek subsidiary has received Emergency Use Authorization (EUA) from the FDA for the use of DNA Genotek’s OMNIgene ORAL (OM-505, OME-505) saliva collection and stabilization device in COVID-19 testing.

This is the first FDA EUA that allows for the unsupervised use of the device at home or in a health care setting when used as part of an approved or validated at-home test kit. With this FDA authorization, OMNIgene ORAL devices can be used for the self-collection, transport and laboratory testing of saliva specimens.

In simpler terms, patients can collect their own sample without a health care professional present.

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OraSure’s management noted that easy-to-use and reliable methods to detect COVID-19 are crucial to meet the massive need for testing, which the Rockefeller Foundation estimates at 2.4 billion tests annually in the United States alone.

As it stands, DNA Genotek has scaled up manufacturing of saliva collection devices to meet customer demand for COVID-19 testing, and it plans to significantly increase capacity in the first quarter of 2021.

Excluding Monday’s move, OraSure Technologies stock had outperformed the broad markets with a gain of about 72% year to date. In the past 52 weeks, the share price was up closer to 63%.

OraSure Technologies stock traded up 24% to $17.20 early Monday, in a 52-week range of $5.23 to $19.75. The consensus price target is $19.29.

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