The US Food and Drug Administration said Thursday that it has granted Roche Emergency Use Authorization for a new version of its multiplex molecular assay for detecting SARS-CoV-2 and influenza A/B.

The US Food and Drug Administration (FDA) has approved LetsGetChecked’s at-home testing system for chlamydia and gonorrhoea.

Roche announced on Thursday it received CE marking for two serology tests for hepatitis E.

Sansure Biotech has achieved a milestone in the field of immunodiagnostics, marking significant progress in international strategic expansion. On the evening of November 14, Sansure Biotech announced that its automated chemiluminescence immunoassay (CLIA) systems recently received the EU CE IVDR certification.

Foundation Medicine, Inc., and Pierre Fabre Laboratories today announced a collaboration to develop Foundation Medicine’s high-quality genomic tests, FoundationOne®CDx and FoundationOne®Liquid CDx, as companion diagnostics for new targeted therapies to treat patients with non-small cell lung cancer (NSCLC).

As of 31 October 2023, over 50 Chinese IVD listed companies have announced their Q3 financial results.

Biotech company AnchorDx has entered into a long-term partnership with molecular diagnostics firm DiaCarta to develop and commercialize cancer diagnostic products for the global market.

Agilent Technologies on Tuesday said it gained US Food and Drug Administration approval of the firm's PD-L1 companion diagnostic assay for use in identifying gastric or gastroesophageal junction adenocarcinoma patients for a combination treatment with Merck's Keytruda (pembrolizumab) checkpoint inhibitor.

China Association of In Vitro Diagnostics (CAIVD) and In Vitro Diagnostics Society of China Association for Medical Devices Industry jointly compiled this report.

Cue Health Inc. ("Cue") (Nasdaq: HLTH), a healthcare technology company, today reported financial results for the third quarter 2023.

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today reported financial results for the third quarter ended September 30, 2023.

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

Hologic reported after the close of the market Thursday that its non-COVID fiscal fourth quarter organic revenues grew 17 percent compared to one year earlier on a constant currency basis with double-digit organic growth across all its divisions.

ARUP Laboratories said Friday its companion diagnostic to help identify which patients are eligible for treatment with a gene therapy for hemophilia A received CE marking under the European Union's In Vitro Diagnostics Regulation (IVDR).

Illumina, Inc. (Nasdaq: ILMN) ("Illumina" or the "company") today announced its financial results for the third quarter of fiscal year 2023, which include the consolidated financial results for GRAIL.