Fulgent Genetics receives CE mark for FulgentExome, Fulgent PLM

Fulgent Genetics (FLGT) announced it has received CE certification under the European Union’s In Vitro Diagnostic Regulation 2017/746 for its germline next-generation sequencing system, which includes FulgentExome and Fulgent Pipeline Manager. Based on available information, Fulgent may be the first laboratory to receive CE mark for one of the most comprehensive end-to-end germline testing offerings, with more than 4600 genes validated for diagnostic use.