SEOUL, KOREA / ACCESSWIRE / June 8, 2020 / With the spread of the Novel Coronavirus Pandemic (COVID-19) worldwide, orders for Korean diagnostic kits are rushing. As part of an effort to combat COVID-19, Joonghun Pharmaceutical also announced that it is accelerating its efforts to provide its own COVID-19 in vitro diagnostic kit ‘JD COVID-19 qRT-PCR Kit’ internationally.
‘JD COVID-19 qRT-PCR Kit’ is based on the Real-time RT-PCR (Real-time Reverse Transcription Polymerase Chain Reaction) method, which is currently the main testing method for detecting the SARS CoV2 virus in COVID-19, because of its excellent sensitivity and specificity.
Joonghun Pharmaceutical’s diagnostic qRT-PCR kits detect a single gene (N gene) of the coronavirus, which is based on the FDA and CDC’s response to combat COVID-19. Targeting a single gene is in accordance with FDA’s Test Validation FAQs which note that recent evidence suggests appropriately validated single gene detection (single viral target SARS-CoV-2 assay) could provide acceptable performance. Joonghun’s target of the N gene is based on US CDC’s own diagnostic kit ‘CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel’ which tests for N genes as well.
According to the official explanation of Joonghun Pharmaceutical, “We have successfully conducted clinical trials using the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) clinical guidelines through cooperation with university research institutes and government agencies.” Furthermore, “Based on these clinical results, on April 17, we obtained the export license from the Korean Ministry of Food and Drug Safety and received the European in vitro diagnosis (CE-IVD) certification, so that we could have a foothold to meet various needs around the world.”
Currently, Joonghun Pharmaceutical is awaiting results of its FDA EUA application which was submitted last May 4th, 2020. The FDA approval process is expected to proceed smoothly as the superiority of the product is validated through clinical trials. The spokesperson for Joonghun Pharmaceutical has said supply requests for diagnostic kits are still constantly coming in from South America, Europe and parts of Asia where COVID-19 is still spreading and obtaining EUA approval will provide another source of validation for these markets.
Meanwhile, Joonghun Pharmaceutical also produces Joonghun Ribavirin capsule, one of 35 medicines released by the Korea Health Insurance Review and Assessment Service as a COVID-19 treatment. “Recently, inquiries regarding Joonghun Ribavirin capsules surged from public institutions and distributors in countries such as Europe and South America, and in March, at the request of Luxembourg, a total of 42,000 capsules were urgently exported,”.
According to Joonghun Pharmaceutical, “In order to contribute and quickly stabilize the global impact caused by COVID-19, we will increase the production of urgent medicines and respond quickly to requests from domestic and international entities in need”. Joonghun’s ‘JD COVID-19 qRT-PCR Kit’ is produced in a GMP facility for pharmaceuticals and medical devices will be able to provide a stable supply.” Joonghun Pharmaceutical also added, “In order to actively respond to the worldwide demand for diagnostic kits, we are also planning to release a rapid test kit in June.”
SOURCE: Joonghun Pharmaceutical Co., Ltd.
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