FDA: Applied DNA's Assay Kit Can Detect UK Mutant
“Testing, testing: Applied DNA Sciences’ Linea COVID-19 Assay Kit can detect the mutant “UK strain,” according to the FDA.
By GREGORY ZELLER // JANUARY 11, 2021
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.
