Shares of OraSure Technologies (NASDAQ:OSUR) were soaring 15.2% as of 11:09 a.m. EDT on Monday. The big jump came after the company announced that the Food and Drug Administration granted Emergency Use Authorization (EUA) for the OMNIgene ORAL saliva collection and stabilization device used in coronavirus testing. The device was developed by OraSure's subsidiary DNA Genotek.
The FDA has issued EUAs for several COVID-19 diagnostics tests so far. But this one is the first device given a green light by the FDA where patients can collect their own saliva samples without a healthcare professional being present and send the samples to a lab for testing.
It's highly likely that the demand for testing will increase as an anticipated next wave of coronavirus outbreaks hits the U.S. The Rockefeller Foundation projects that 2.4 billion COVID-19 tests will be needed annually just in the U.S.
OraSure should have a tremendous market opportunity with OMNIgene ORAL now that it has secured an EUA. The device is already available for use in the European Union.
Other FDA decisions could be additional catalysts for the healthcare stock in the near future. OraSure hopes to soon win EUAs for its OraQuick coronavirus rapid antigen self-test and its OraSure SARS-CoV-2 antibody test. If all goes well, the company anticipates launching these products before the end of the year.