The US Food and Drug Administration said on Wednesday it has issued de novo classification to Fujirebio Diagnostics' Lumipulse G β-Amyloid Ratio (1-42/1-40) test, allowing the company to market it as a tool for diagnosing Alzheimer's disease.

BioMérieux said on Wednesday that its BioFire Joint Infection (JI) Panel has received de novo 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.

Existing methods for detecting and diagnosing COVID-19 are either expensive and complex or inaccurate.

Diagnostics instrument and reagent developer MicroGem announced on Tuesday that it has obtained Emergency Use Authorization from the US Food and Drug Administration for a rapid point-of-care PCR instrument and COVID test.

On April 15, Wuhan Easy Diagnosis Biomedicine, Shenzhen YHLO Biotech and Acrobiosystemsreleased its first quarter results forecast for 2022

The US Food and Drug Administration this week granted Emergency Use Authorization for the Cleveland Clinic's SelfCheck Cobas SARS-CoV-2 + Flu Assay.

The US Food and Drug Administration on Thursday announced it has granted Emergency Use Authorization to InspectIR Systems' InspectIR COVID-19 Breathalyzer test, making it the first breath-based test for detecting SARS-CoV-2 to receive such designation.

Shanghai Fosun Pharmaceutical on Thursday announced that China's National Medical Products Administration (NMPA) has granted approval for Fosun Diagnostic's Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Colloidal Gold) for COVID-19 screening.

On April 13, the SARS-CoV-2 Rapid Antigen Test (immunochromatography Assay) developed by Sansure Biotech Inc. has obtained CE certification! This means that the test can be sold in EU countries and countries that recognize EU CE certification.