JURUPA VALLEY, Calif. (PRWEB) July 29, 2021
The FDA has authorized the GenBody COVID-19 Ag test for Emergency Use Authorization for use in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Kwell Laboratories is the exclusive U.S. distributor for GenBody, Inc. GenBody, established in 2012, is a leading South Korean manufacturer of rapid diagnostic kits and reagents for point of care applications for COVID-19 and other diseases.
“GenBody has made easy to use and accurate COVID-19 testing available globally and we are pleased to now bring this advanced South Korean technology to the U.S.” shared the CEO of GenbBdy Inc. Dr. James Chong. “The need for fast and affordable rapid test kits is especially strong now that we are seeing a rise in COVID-19 outbreaks due to variants and as the U.S. continues to open up. We are excited to offer this highly effective test to the US and we are looking forward to bringing additional product releases.” stated David Yoo, CEO of Kwell Laboratories.
GenBody, in partnership with Kwell Laboratories, was awarded a National Institute of Health (NIH) Rapid Acceleration of Diagnostics (RADxSM) initiative award of an estimated $10 million in support of U.S. production of GenBody's innovative point of care test that will increase the capacity of fast, affordable and easy to use testing in the U.S. An at-home test is also in development for future use.
Founded in 2012, GenBody creates innovative technologies for diagnostic tests globally. GenBody manufactures 85 kinds of rapid diagnostic tests for human and veterinary use including influenza A/B ag, strep A ag, mycoplasma Ag, Zika, Dengue, cardiac marker and cancer marker. GenBody is a vertically integrated manufacturer of rapid Covid-19 Ag from its in-house monoclonal antibody production to final assembly of the testing device.
This project has been funded in part by the NIH Rapid Acceleration of Diagnostics (RADxSM) initiative with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health. The current contract is funded from the Public Health and Social Services Emergency Fund through the Biomedical Advanced Research and Development Authority, HHS Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services, under Contract No. 75N92021C00007.