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OnsiteGene Receives FDA Emergency Use Authorization (EUA)

OnsiteGene is pleased to announce that it has received Emergency Use Authorization (EUA) on Dec 19th, 2022, from the U.S. Food & Drug Administration (FDA) for Hi-Sense COVID-19 Molecular Testing Kit 1.0 Test, a rapid molecular diagnostic test for qualitative detection of the viruses causing COVID-19. The test is designed for use on Star Array XDive Superfast Real-Time PCR System as described in the Instructions For Use (IFU), with results delivered in approximately 20 minutes.

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XDive Superfast Real-Time PCR instrument is based on a patented superfast thermal cycling technology capable of completing 40 PCR cycles in 5 minutes. OnsiteGene has also developed a sample-to-answer, rapid, ultra-sensitive, low-cost, small to large syndromic panel (multiplexing), and POCT CLIA-waived instrument called PeakV. PeakV is an open platform and works for all Taqman assays. The company is under NIH RADx program and seeks collaborators to co-develop the various POC and lab based genetic testing applications.

About Emergency Use Authorization Status

This test has not been FDA cleared or approved but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories. This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19.


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