UK molecular diagnostics company Genedrive said on Wednesday that its rapid molecular COVID-19 test has received CE marking.

FDA has granted another set of regulatory privileges under its breakthrough devices program. The latest batch is led by breakthrough designations for treatments of lung cancer and bone metastases that are in development at RefleXion Medical and Zetagen Therapeutics.

The US Food and Drug Administration said on Friday that it has updated its website tracking the potential impact of SARS-CoV-2 variants on molecular diagnostic tests to include tests likely affected by the Omicron variant.

The US Food and Drug Administration on Tuesday granted Emergency Use Authorization for an at-home sample collection kit for SARS-CoV-2 molecular testing developed by nonprofit digital health firm Audere.

One of the first jobs the US Food and Drug Administration’s new inspections council will take on is developing policy around the agency’s use of Remote Regulatory Assessments.

The US Food and Drug Administration announced on Friday that it has issued two final orders reclassifying certain hepatitis C diagnostic tests from Class III to Class II. Additionally, it reclassified blood lancet devices from Class I to Class II and Class III.

The US Food and Drug Administration on Monday released revised guidance on its regulatory priorities and policies for COVID-19 tests.

The funding will be used to provide purchase commitments to manufacturers so they can scale up test production.

Meridian Bioscience announced on Wednesday that its Revogene SARS-CoV-2 test has received Emergency Use Authorization from the US Food and Drug Administration.

Britain said it would recognise COVID-19 vaccines on the World Health Organization's Emergency Use Listing later this month.