SpectronRx’s High-Capacity, 1.5 Hour SARS-CoV-2 Test Kit Secures Emergency Use Authorization

By LabMedica International staff writers
Posted on 19 Jun 2020

SpectronRx (Indianapolis, Ind., USA) has secured Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its Hymon SARS-CoV-2 Test Kit.

The Hymon SARS-CoV-2 Test Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper respiratory specimens (such as nasal, mid-turbinate, nasopharyngeal, and oropharyngeal swab specimens) and bronchoalveolar lavage specimens from individuals suspected of COVID-19 by their healthcare provider. The PCR test can be performed on Applied Biosystems 7500 PCR systems, providing rapid results in a wide range of healthcare settings such as diagnostic labs and hospitals in the US, and can also be utilized in mobile or rural environments.

Image: Hymon SARS-CoV-2 Test Kit (Photo courtesy of SpectronRx)

“We are excited to contribute to the global battle against coronavirus by providing an efficient, real-time diagnostic PCR test to detect SARS-CoV-2,” said John Zehner, CEO of SpectronRx. “The shortage of tests nationwide has hindered proper diagnostic assessment of health in our communities – we are bringing testing to our communities, and hoping our contribution elevates the standard of diagnosis and provides a clear path of epidemiologic assessment during our ongoing fight against coronavirus.”

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