NEW YORK (GenomeWeb) – The US Food and Drug Administration has amended the Emergency Use Authorization it issued to Focus Diagnostics for its RT-PCR Zika assay, the agency announced last week.
The Zika Virus RNA Qualitative Real-Time RT-PCR Test is now permitted for use with urine when samples are collected alongside patient-matched serum specimens. Focus is now also permitted to use commercially sourced, inactivated Zika virus as a positive control material in addition to live virus of the Zika FLR strain. Further, the company will be allowed to update the user instructions on its test with results of the FDA Reference Material sensitivity studies, and to combine the Pregnant Women and Patient Fact Sheets into a single patient fact sheet.
The Focus Diagnostics test — which can be performed at any CLIA high-complexity laboratory — was originally granted EUA in April and was the first test from a commercial laboratory provider to be granted such authorization after the Zika emergency was declared in March.