Healgen’s COVID-19 IgG/IgM Rapid Test Kit Granted FDA Emergency Use Authorization

Healgen Scientific, LLC’s (Houston, TX, USA) COVID-19 IgG/IgM Rapid Test Kit has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA).

As a result of the FDA authorization, Confirm BioSciences (San Diego, CA, USA), the largest North American distributor for Healgen, a subsidiary of Zhejiang Orient Gene Biotech, maker of the COVID-19 test, will have an ample supply of test kits for medical professional use starting in early June. Confirm expect to have millions of tests available, enough to satisfy existing pre-orders and future orders. Zhejiang has also appointed Aytu BioScience, Inc. (Englewood, CO, USA) as the US distributor for the COVID-19 test and has delivered more than 1.4 million rapid tests to the company for distribution in the country.

An easy-to-use test kit that provides results in just 10 minutes, COVID-19 IgG/IgM Rapid Test kits are designed for use with whole blood, serum or plasma samples. With a high degree of accuracy, the kits detect IgM that may appear in blood within three-five days following incubation and IgG that appears as soon as 1-2 weeks. As part of the FDA review, a National Institutes of Health (NIH) study comparing rapid test kits found that the COVID-19 Rapid Test demonstrated excellent performance. The tests are authorized for prescription use only for use in high or moderately complex CLIA laboratories. The kits have a shelf life of 24 months from the date of manufacture and can be stored at room temperature or in a refrigerator.

"We have received positive feedback on the test from our customers and independent studies, so the FDA Emergency Use Authorization validates what we already knew from real-world clinical applications," said Albert Berger, Chief Executive Officer, Confirm BioSciences. "This pandemic is an enormous challenge for medical professionals and everyone else, and as a major distributor, we're proud to do our part to increase testing capacity so that healthcare professionals can help contain the spread of the virus."