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Altona Dx MERS Test Lands FDA Emergency Use Authorization

NEW YORK (GenomeWeb) – Altona Diagnostics today announced that the US Food and Drug Administration has granted an Emergency Use Authorization for the firm's test for Middle East Respiratory Syndrome Coronavirus (MERS-CoV).

The RealStar MERS-CoV RT-PCR Kit US is a real-time, reverse-transcriptase PCR-based test for in vitro qualitative detection of RNA from the MERS-CoV in lower respiratory samples from individuals with signs and symptoms of infection. It runs on a variety of instruments including the Applied Biosystems ABI Prism 7500 SDS or 7500 Fast SDS; the Bio-Rad CFX96, CFX96 Dx Real-Time, or CFX96 Touch Deep Well Real-Time PCR Detection System; the Roche LightCycler 480 Instrument II; the Corbett Research Rotor-Gene 6000; the Qiagen Rotor-Gene Q 5plex, Rotor-Gene Q 6plex, or Rotor-Gene Q MDx Platform; and the Siemens Versant kPCR Molecular System AD. Only CLIA high-complexity or similarly qualified non-US laboratories may perform the test.

First identified in a Saudi Arabian patient in 2012, MERS-CoV spread to South Korea in May this year. According to the World Health Organization, the outbreak in South Korea has led to 185 confirmed cases including 36 deaths. There has also been one confirmed case in China.

In April, the US Centers for Disease Control and Prevention presented results from its evaluation of three MERS-CoV diagnostics, one of which was the Altona test. The Altona test had the same limit of detection as the CDC's own test.

The FDA also granted Hamburg, Germany-based Altona an EUA for its RealStar Ebolavirus RT-PCR Kit 1.0 last year.