Danaher subsidiary Cepheid announced on Thursday that its Xpert Xpress CoV-2 plus test has received Emergency Use Authorization from the US Food and Drug Administration.

Pfizer and BioNTech have submitted an application for Emergency Use Authorization for a COVID-19 vaccine booster dose in young children.

C2i Genomics launches minimal residual disease test across Europe after clearing regulatory hurdles in the EU, UK, and Switzerland.

On April 6, it was reported that the Rapid SARS-CoV-2 Antigen Test Card produced by Xiamen Boson Biotech Co., Ltd. has obtained the FDA Emergency Use Authorization (EUA).

Jinan Babio Biotechnology Co., Ltd. recently received an official notification from the EU Notified Body for its self-tested novel coronavirus antigen detection product, and subsequently obtained the CE certification issued by PCBC.

On March 23, 2022, AutoBio’s SARS-CoV-2 Ag Rapid Home Test successfully passed the European clinical assessment and the audit of the notified institution, obtained the EU CE certificate.

The US Food and Drug Administration this week granted separate Emergency Use Authorizations for three direct-to-consumer SARS-CoV-2 tests from Quest Diagnostics, as well as a home sample collection kit for use with the tests.

Joinstar’s COVID-19 Antigen Rapid Test (Colloidal Gold) anterior nasal-self testing device, was awarded the CE certificate issued by EU.

Illumina said on Tuesday that it has received CE-IVD marking for its TruSight Oncology Comprehensive (EU) assay this month.

The European Union's in vitro diagnostic expert panel has published its first opinion on an In Vitro Diagnostic Medical Devices Regulation (IVDR) submission, delivering a glowing opinion of the filing for a test to screen plasma donor samples for hepatitis E virus (HEV).