Philosys Obtains CE-IVD Certification for Three COVID-19 Diagnostic Kits

[Asia Economy Reporter Eunmo Koo] Philosis, an affiliate of Philosis Healthcare, announced on the 21st that it has obtained CE-IVD certification for three types of COVID-19 diagnostic kits.

The three products that received CE-IVD certification this time are the antibody diagnostic kit Gmate COVID-19 IgG IgM, the antigen diagnostic kit Gmate COVID-19 Ag, and the molecular diagnostic kit Gmate COVID-19 RT-PCR.

Philosis Healthcare, which holds the distribution rights for Philosis's diagnostic kits, has established a lineup of about four diagnostic kits, including the existing antigen diagnostic kit Gmate COVID-19. In particular, the antibody diagnostic kit, along with the specimen collection kit, has received many inquiries and requests within the United States, and it is known that the Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) is already underway.

A representative from Philosis Healthcare explained, "There is a high demand to use antigen diagnostic kits and molecular diagnostic kits concurrently, so we strategically expanded our lineup. Overseas, testing is first conducted with our Gmate COVID-19, and if the result is positive, confirmation is done with the molecular diagnostic kit, complementing each other."

They added, "The newly added antigen diagnostic kit has the advantage of a shorter testing time and lower cost compared to the existing Gmate COVID-19, although its accuracy is lower. The antibody diagnostic kit is also expected to play a significant role in the COVID-19 antibody formation stage."