Dutch molecular diagnostics firm Genome Diagnostics said on Friday that it has received a European Union Quality Management System Certificate under the new In Vitro Diagnostic Medical Devices Regulation (IVDR) for its portfolio of human leukocyte antigen (HLA) products.

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.

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

SeekIn said on Thursday that it has received CE marking for its LeukoPrint Molecular Karyotyping Kit for the diagnosis and stratification of leukemia patients.

HTG Molecular Diagnostics reported after the close of the market on Tuesday that its 2021 revenues edged up 5 percent to $8.9 million from $8.5 million a year ago.

The US Food and Drug Administration last week granted Emergency Use Authorization for a SARS-CoV-2 molecular test developed by Helix.

Cue Health said on Wednesday that it has received interim order authorization from Health Canada to sell its at-home molecular COVID-19 self-test in that country.

Lucira Health on Thursday reported a huge year-over-year surge in revenues for the fourth quarter of 2021 on ramped-up manufacture and sale of the company's molecular at-home COVID-19 tests.

Roche Diagnostics has launched its new molecular laboratory instrument, the cobas 5800 System, in the UK. Through improved automation, the new system can help raise testing volumes, improve operational efficiency, and manage the increasing demand that many laboratories are experiencing, Roche said.

Luminex, a DiaSorin company, said on Tuesday that it has received CE marking for its xMap NxTag Gastrointestinal Pathogen Panel (GPP), a molecular multiplex panel for the detection of 16 different pathogens.