In the face of the escalating mpox outbreak, health authorities worldwide are on high alert, particularly with the emergence of the more contagious and aggressive clade Ib. The surge in cases has intensified the need for rapid and accessible diagnostic tools to curb the spread of the virus.

QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, announced today that it has been granted CLIA Waiver from the U.S. Food and Drug Administration (FDA), applying to its new Sofia® 2 SARS Antigen+ FIA.

On the evening of July 12, Zhejiang Orient Gene Biotech Co., Ltd announced that its wholly owned subsidiary, Shanghai Wanzi Health Medical Laboratory Co., Ltd., had obtained medical device registration certificates for carcinoembryonic antigen, neuron-specific enolase, and cytokeratin 19 fragment detection kit (flow fluorescence luminescence method).

LumiraDx Limited (Nasdaq: LMDX), a leading innovator in diagnostic technologies, today announced the submission of its first 510(k) application to the U.S. Food and Drug Administration (FDA) for the clearance of its ground-breaking 5-minute COVID Ultra Test. LumiraDx submitted a traditional 510(k) Dual Submission for LumiraDx SARS-CoV-2 Ag Ultra with CLIA Waiver for the commercial distribution at point of care of the LumiraDx Platform, including the LumiraDx Instrument, with the LumiraDx SARS-CoV-2 Antigen (Ag) Ultra test, and the LumiraDx SARS-CoV-2 Ag Quality Control Swab Kit.

China's foreign ministry said on Tuesday that all inbound travellers will only need to show COVID-19 antigen tests result taken within 48 hours before boarding flights starting April 29, dropping the PCR test requirement.

QuidelOrtho Corporation, a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, announced today that it has been granted a De Novo request from the U.S. Food and Drug Administration (FDA).

The US Food and Drug Administration on Wednesday granted Emergency Use Authorization for Mologic's over-the-counter SARS-CoV-2 antigen test.

On the evening of January 19, Andon Health Co., Ltd. released the 2022 performance forecast, and it is expected that the company's net profit in 2022 will be 16.5 billion CNY to 17.5 billion CNY, a year-on-year increase of 1715.9% to 1825.95%.

Jiangsu Huadong Medical Device Industrial and Getein Biotech have signed an agreement to jointly manufacture and sell antigen test kits for Covid-19 and other in vitro diagnostics (IVD) products.

Roche Diagnostics China and Beijing Hotgene Biotechnology Co., Ltd. have reached a cooperation to jointly launch the novel coronavirus (2019-nCoV) antigenic detection kit on the basis of fully integrating the advantages of technology and resources of both sides.