NEW YORK – SolGent said on Thursday that it has received the CE mark for its DiaPlexQ Novel Coronavirus (2019-nCoV) Detection assay, as well as authorization from regulatory authorities in Korea and the Philippines.
The company's test qualitatively detects the Orf1a and N genes of the novel coronavirus in sputum, oropharyngeal, and nasopharyngeal specimens from patients with suspected respiratory infection.
SolGent, based in South Korea, received the CE mark on Feb. 26, emergency use authorization from the Korean Ministry of Food and Drug Safety on Feb. 27, and approval from the Philippines Department of Health Food and Drug Administration on March 19.
Solgent is a subsidiary of Eone-Diagnomics Genome Center (EDGC), which is based in Incheon, a city near Seoul.