Roche announced Tuesday that its PCR-based test for vaginitis has received CE marking. The test is now available in countries accepting the designation.

The Global Health Innovative Technology (GHIT) Fund said Monday that it has invested ¥70 million ($460,000) in the development of a prototype molecular assay to detect mpox.

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

Scout Health announced Wednesday that it has been awarded up to $6 million in funding support from the antimicrobial resistance nonprofit CARB-X. The firm plans to use the funding to finalize development of a next-generation version of its rapid point-of-care system and assay for chlamydia and gonorrhea and hopes to soon begin pilot studies in low- and middle-income countries (LMICs).

The U.S. Food and Drug Administration (FDA) has approved the Promega OncoMate® MSI Dx Analysis System as a companion diagnostic designed to identify patients with microsatellite stable (MSS; defined as not MSI-high [not MSI-H]) endometrial carcinoma who may benefit from treatment with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, plus LENVIMA® (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai. This is the first Promega companion diagnostic to receive FDA approval.

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

Biodesix, Inc. (NYSE: BDSX), a leading diagnostics solutions company, today announced the signing of an expanded partnership agreement under which Biodesix will conduct the development, clinical validation, and regulatory submissions of in vitro diagnostic (IVD) assays to enable highly sensitive detection of multiple genomic markers focused on oncology applications, utilizing Bio-Rad’s Droplet Digital™ PCR (ddPCR™) technology on Bio-Rad’s QX600 platform. Following regulatory clearance, Biodesix will manufacture and distribute dedicated specimen collection kits for the developed assays.

Hitachi High-Tech Corporation ("Hitachi High-Tech"), and ELITechGroup S.p.A. (Head Office: Italy, "ELITech") have entered a Collaboration, Manufacturing and Supply Agreement (the "Agreement") in the field of molecular testing for infectious disease.

Roche on Monday announced that its Cobas Respiratory 4-flex test for SARS-CoV-2, influenza A/B, and respiratory syncytial virus has received clearance from the US Food and Drug Administration.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) and GENCURIX, Inc. (KOSDAQ: 229000) today announced a new partnership to develop oncology assays for use on the QIAcuityDx platform, a high-performance digital PCR system designed for clinical diagnostics.