Macrogen obtained export approval for COVID-19 test kit 'AxenTM COVID-19 RT'

Food and Healthcare Press Releases Thursday May 21, 2020 09:30
SEOUL South Korea--21 May--PRNewswire/InfoQuest

The Korean biotech company Macrogen (CEO Sukang Lee) (KOSDAQ: 038290), announced that it obtained export approval for COVID-19 test kit 'AxenTM COVID-19 RT' from the Ministry of Food and Drug Safety (MFDS) on the 18th.

Macrogen's COVID-19 test kit is a product that uses RT-PCR, and can confirm whether the person is infected with COVID-19 in just two hours, which allows for conducting a large number of tests quickly and efficiently. As the kit detects ORF1ab and E genes, two genes related to COVID-19, it has a high level of accuracy and target detection. Hence, the test kit is evaluated as more appropriate to screen patients with trace amounts of COVID-19. Earlier, Macrogen collected samples from the upper and lower airway of COVID-19 patients, and conducted a clinical trial with its test kit AxenTM COVID-19 RT. Macrogen confirmed 100% consistency in 20 samples each in the positive and negative groups and reported these results to the MFDS.

Macrogen applied various guidelines including a Draft International Standard by the International Organization for Standardization's (ISO) technical committees of medical devices, and completed its self-development of the test kit AxenTM COVID-19 RT last month.   Macrogen, is recognized as a company with reliable diagnostic technology and an accuracy, obtained enough raw materials to produce at least 100,000 tests per week and completed the kit production system and process in accordance with GMP regulations.

Even before this export approval, a surge of inquiries about how to purchase Macrogen's test kit rushed in from many countries including Brazil and Uruguay. This suggests that Macrogen has been acknowledged for its technology based on its 24 years of genome analysis expertise, and diagnostic reagent development experience. Macrogen has targeted the global market with its glocalization strategies and maintained a high level of recognition and customer trust in research, clinical diagnostics, personal genome, and microbiome. In particular, Macrogen boasts an all-encompassing business portfolio, which includes Korea's   leading virus research in the face of the outbreak of novel viruses, such as MERS and SARS as well as its manufacture of oligo, the key material in a diagnostic reagent, and production of model mice for therapeutics and vaccine development.

Currently, Macrogen is preparing to obtain Emergency Use Authorization (EUA) from the U.S. FDA and Europe's CE In-Vitro Diagnostics (CE-IVD). These authorizations are expected to increase Macrogen's exports across the U.S. and Europe as well as Brazil and Uruguay, in which the test kit is currently under negotiation.

Macrogen CEO Sukang Lee said, "We are planning to supply our test kit to major countries, which contacted us even during the test kit development phase and were looking forward to export approval together with us, first and as early as possible. We will not only improve our test kit's performance to detect numerous mutations of coronavirus, which continue to appear in the future, but also promptly respond to prolonged COVID-19 and any new emerging virus."
Photo -
Caption -   "AxenTM COVID-19 RT"

Latest Press Release

Philips receives FDA clearance for the use of its ultrasound portfolio to manage COVID-19-related lung and cardiac complications

Philips’ ultrasound portfolio, including Lumify with Reacts handheld tele-ultrasound solution, provides valuable diagnostic insight for front-line care providers Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today...

Technopath Clinical Diagnostics Launches the First Not-For-Profit COVID-19 Antibody Testing Initiative to Support Companies in Ireland

Technopath Clinical Diagnostics today announced that it is rolling out COVID-19 antibody testing in Ireland to help businesses navigate a safer workplace re-entry. This initiative will provide key services to all industries and will be offered on a...

DERMALOG Fever Check at Clever Fit Gym

After a mandatory corona break of several weeks, sports facilities and fitness studios in Germany are reopening. Operators have to comply with numerous hygiene regulations to minimize infection risks for customers and employees. This is why German Clever...

Eleva's Drug Candidate to Be Examined for Use in COVID-19 Treatment

Eleva, a manufacturer of superior biologics, is exploring the potential of one of its drug candidates for first-in-line therapy of COVID-19. The compound, factor H, is part of the complement system, which is believed to affect the severity of the course...

QPS Awarded Two 2020 CRO Leadership Awards

QPS is a GLP/GCP-compliant and CLIA-certified contract research organization (CRO) delivering discovery, preclinical, and clinical drug development services since 1995. An award-winning leader focused on bioanalytics and clinical trials, QPS, has been...

Related Topics