FDA Issues EUA to HymonSARS-CoV-2 Test Kit for Detection of COVID-19

The U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for SpectronRx’s HymonSARS-CoV-2 Test Kit.

According to SpectronRx, the kit offers the following benefits:

• 1.5-hour testing time, from prep to finish;

• 94 sample capacity (+ controls) per kit;

• LOD (Limit of Detection) of 1.2 copies of SARS-CoV-2 RNA/uL = 5 copies per reaction;

• Low laboratory footprint requirement.

The HymonSARS-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.

“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.”

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 U.S., and can also be utilized in mobile or rural environments. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C. §263a, to perform high complexity tests. SpectronRx and its partner, HymonBio, expect to produce 10 million tests per month for laboratories around the world.