On May 6, 2020, PharmaCyte Biotech announced it had received Medical Devices Establishment Registration with the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH). The CDRH requires this registration for companies that plan to import medical devices from overseas suppliers. The company also established itself as the sole U.S. agent for Hai Kang Life Corp. for the importation of SARS-CoV-2 in vitro diagnostic test kits. The company plans to market its PCR-based diagnostic tests kits to Clinical Laboratory Improvement Amendments certified labs throughout the U.S.

The company also announced that it is in dialogue with the FDA through a Pre-Emergency Use Authorization (EUA) submission to the FDA. An EUA is a legal means for the FDA to expeditiously approve new drugs and new medical devices during a declared national emergency. For COVID-19 diagnostic test kits, the FDA recommends that manufacturers and suppliers file a Pre-EUA with the FDA in order to interactively work towards an eventual EUA submission and approval by the FDA. The FDA encourages companies to file an early draft so that the FDA examiner can offer feedback to avoid delays during the review of the final EUA application.

PharmaCyte’s diagnostic test kits, which were developed by and licensed from Hai Kang Life Corporation Limited (Hai Kang), for detecting the SARS-CoV-2 virus is the Enhanced Real-Time PCR (ERT-PCR) method. The technology is the same as the previous test for the SARS outbreak in 2003 that was published in the New England Journal of Medicine, but the primers and probes used in the current test is specific for the novel coronavirus. This means test results are positive only if the SARS-CoV-2 target sequences are present in the test sample.