Indianapolis-based SpectronRx has announced that the U.S. Food and Drug Administration has issued Emergency Use Authorization for its test kit used for detection of the novel coronavirus. SpectronRx says the test kit features a 1.5-hour testing time and a low laboratory footprint requirement.
The company says its HymonTMSARS-CoV-2 Test Kit is a real-time test intended for the detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens, such as nasal swabs, and 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 CEO John Zehner 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 test can be performed on systems that SpectronRx says provides rapid results in diagnostic labs and hospitals in the U.S. and can also be used in mobile or rural environments.
SpectronRx and its manufacturing partner, China-based biotechnology company HymonBio Co. LTD, say they expect to produce 10 million tests per month for laboratories around the world.