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Vela Diagnostics Receives EUA for Zika MDx

A previous version of this story incorrectly stated the Vela Zika test workflow uses Qiagen's Rotor-Gene Q platform. It uses the Applied Biosystems 7500 Fast Dx Real-Time PCR platform.

NEW YORK (GenomeWeb) – A Zika assay from Singapore-based molecular diagnostics firm Vela Diagnostics has received Emergency Use Authorization from the US Food and Drug Administration.

The Sentosa SA ZIKV RT-PCR Test processes 22 samples in three hours using Vela's Sentosa SX Virus Total Nucleic Acid Kit v2.0, and the Sentosa SX101 system for automated nucleic acid extraction and PCR set-up followed by thermal cycling on Applied Biosystems' 7500 Fast Dx Real-Time PCR platform.

For patients meeting US Centers for Disease Control and Prevention clinical or epidemiological criteria, the test is authorized to detect Zika RNA in serum, plasma, and urine collected alongside patient-matched serum or plasma.

Vela's Zika test was launched as a research-use-only product in January and received CE marking last month.