Sophia Genetics said that it has received CE-IVD marking for analytics functionality of its core Sophia Data Driven Medicine (DDM) software platform. The Swiss-American firm made the announcement Tuesday at the European Society of Human Genetics conference in Vienna.

LumiraDx said on Wednesday that it has received CE marking for a molecular SARS-CoV-2 test and an assay that tests for both SARS-CoV-2 and influenza virus.

Monkeypox is a zoonotic disease that was first identified in monkeys in 1958. Although it is named monkeypox virus, its primary host is rodents such as mice and squirrels, and its opportunistic host is primates, humans.

DoMore Diagnostics has obtained the CE mark for its Histotype Px Colorectal deep-learning algorithm to predict colorectal cancer patient outcomes based on the analysis of digital histology images, enabling its clinical use in the European Union and other geographies that accept the designation.

In the face of the sudden monkeypox virus epidemic, many Chinese in vitro diagnostic enterprises responded quickly, completed the R & D and launched the monkeypox virus nucleic acid detection kit at the first time, effectively helping overseas to carry out the monkeypox virus prevention.

On May 23, 2022, Autobio Diagnostics Co., Ltd. announces CE mark for AutoMeloc Monkeypox nucleic acid detection kit (PCR-fluorescent probe method).

Hologic announced Wednesday it has obtained CE marking for its Panther Fusion EBV Quant Assay and Panther Fusion BKV Quant Assay, expanding its transplant pathogen monitoring menu on the automated, real-time PCR Panther Fusion system.

On May 19, the COVID-19 Antigen Rapid Test (colloidal gold method) independently developed by Guangzhou Weimi Bio-Tech Co., Ltd (“Weimi Bio-Tech”) successfully obtained the EU CE certificate.

DiaSorin's Luminex on Friday announced it has obtained CE marking for its Aries Flu A/B & RSV+SARS-CoV-2 Assay, a multiplex molecular panel that detects four common respiratory viruses and their underlying respiratory infections.

Nanomix said on Friday that it has received the CE mark for its eLab COVID-19 antigen test which provides qualitative results in 15 minutes from an anterior nasal swab.