With the worldwide spread of the Novel Coronavirus (COVID-19), orders for Korean diagnostic kits continue to roll in. As part of the effort to combat COVID-19, Joonghun Pharmaceutical announced that it was accelerating efforts to provide its JD COVID-19 qRT-PCR Kit for in vitro diagnostics internationally.
The JD COVID-19 qRT-PCR Kit uses Real-time RT-PCR (Real-time Reverse Transcription-Polymerase Chain Reaction), currently the main testing method for detecting SARS-CoV-2 virus in COVID-19, because of its excellent sensitivity and specificity.
Joonghun Pharmaceutical’s diagnostic qRT-PCR Kit targets a single gene (N gene) of the coronavirus, based on the FDA and CDC response to COVID-19. Targeting the single gene accords with FDA Test Validation FAQs which note recent evidence suggesting appropriately validated single gene detection (single viral target SARS-CoV-2 assay) provides acceptable performance. Joonghun’s targeting the N gene is based on the US CDC diagnostic kit ‘CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel’ which targets N genes as well.
According to Joonghun Pharmaceutical, “We successfully conducted clinical trials using U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) clinical guidelines, in cooperation with university research institutes and government agencies.” Furthermore, “Based on these clinical results, on April 17 we obtained an export license from the Korean Ministry of Food and Drug Safety, and received a European in vitro diagnostic (CE-IVD) certification, providing us with a foothold for meeting various needs around the world.”
Joonghun Pharmaceutical is currently attending results of its FDA EUA application, submitted May 4th, 2020. The FDA approval process is expected to proceed smoothly as the product was verified in clinical trials. A spokesperson for Joonghun Pharmaceutical said requests for the supply of diagnostic kits are constantly coming from South America, Europe and parts of Asia where COVID-19 is still spreading, and obtaining EUA approval would provide another source of validation for these markets.
The company also produces the Joonghun Ribavirin capsule, one of 35 medicines recognized by the Korea Health Insurance Review and Assessment Service as a COVID-19 treatment. “Inquiries regarding Joonghun Ribavirin capsules surged from public institutions and distributors in countries across Europe and South America, and in March, at the request of Luxembourg, a total of 42,000 capsules were urgently exported.”
“In order to contribute and help stabilize the global impact of COVID-19, we will increase the production of medicines, in order to respond quickly to urgent requests from domestic and international entities. Joonghun’s JD COVID-19 qRT-PCR Kit is produced in a GMP facility for pharmaceuticals and medical devices, so we 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.”