FDA: Applied DNA’s assay kit can detect UK mutant

Testing, testing: Applied DNA Science's Linea COVID-19 Assay Kit can detect the mutant "UK strain," according to the FDA.
By GREGORY ZELLER //

Only two COVID-19 test kits earning U.S. Food and Drug Administration Emergency Use Authorization can detect the mutant “UK strain” – and one of them is produced on Long Island.

Applied DNA Science’s Linea COVID-19 Assay Kit has been identified by the FDA as “potentially able to identify certain SARS-CoV-2 mutations, including a mutation found in the UK,” the company said this week.

That’s a direct reference to B.1.1.7, the faster-spreading mutation first identified in the United Kingdom and now confirmed to have crossed the pond, including multiple New York State cases.

According to an FDA “safety communication” issued Jan. 8, the administration monitors the potential effects of viral mutations on EUA-approved test kits – including Applied DNA’s assay, which is actually designed to detect multiple genetic targets associated with SARS-CoV-2, the virus that causes COVID-19.

James Hayward: Very sensitive.

The FDA “will continue to monitor SARS-CoV-2 genetic viral variants to ensure authorized tests continue to provide accurate results for patients,” according to Commissioner Stephen Hahn. But working directly with Applied DNA, the administration has already determined that due to its multi-target design, the Linea COVID-19 Assay Kit’s overall sensitivity “should not be impacted” by the mutant strain, the company said in a statement.

In the same Jan. 8 safety communication, the FDA noted that “the data suggests that the currently authorized COVID-19 vaccines may still be effective against this strain” – good news for Pfizer and other companies that have been able to push vaccines through rushed approval processes.

But for Applied DNA, at least, the big takeaway is the FDA is still greenlighting the Linea COVID-19 Assay Kit for the quick and accurate diagnosis of all novel coronavirus strains.

“Our ability to potentially identify certain variants of SARS-CoV-2 is grounded in the multi-target design of our assay,” noted Applied DNA President and CEO James Hayward, who called the test kit “a fast and cost-efficient” tool for health officials.

And his Stony Brook-based company, which has emerged as a leader in polymerase chain reaction-based DNA manufacturing, is not done innovating its assay kit, the CEO added.

“We have begun to develop new assays to detect specific mutations in SARS-CoV-2 and to adapt our assay to address the evolving SARS-CoV-2 threat,” Hayward said.

 


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