Applied DNA's Coronavirus Test Cleared by FDA for Emergency Use

Applied DNA Sciences' coronavirus test kit is now cleared under the FDA's emergency-use authorization.
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Applied DNA Sciences  (APDN) - Get Report shares jumped on Thursday after the U.S. Food and Drug Administration provided emergency-use authorization for the clinical use of its covid-19 test, Linea. 

Clinical laboratories in the U.S. certified under Clinical Laboratory Improvement Amendments to perform high-complexity tests can immediately begin ordering and using the test to detect coronavirus. 

Applied DNA says Linea is an advanced single-well multiplex test that can be simply set up. The throughput on the test is higher than that of tests that require multiple wells per test. 

"This extraordinary achievement highlights the company’s commitment to combating the covid-19 pandemic both locally and nationwide," Chief Executive James Hayward said in a statement.

The machine that runs the test can process 94 samples per hour and more than 2,000 tests per day. 

"We believe we have developed an assay with numerous commercial advantages over other emergency-use-authorization-approved covid-19 detections assays," said Mohan Chellani, director of diagnostic regulatory affairs. 

Earlier this week, LabCorp  (LH) - Get Report said it was expanding the availability of its coronavirus home-collection test kit, offering it to individuals nationwide who have symptoms consistent with the disease.

The tests were initially made available in April to front-line healthcare workers and first responders. The latest move expanded access in line with U.S. Centers for Disease Control and Prevention guidelines, the Burlington, N.C., laboratory-services company said.

The company said it now has more than 200,000 at-home collection test kits available and is prepared to "significantly expand capacity as required."

Applied DNA Sciences shares at last check were up 56% to $13.89.