QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of its new digital PCR (dPCR) Custom Assay Design Tool for copy number variation (CNV) analysis for use on its digital PCR platform QIAcuity and several other enhancements in its GeneGlobe Design and Analysis Hub, a comprehensive research platform that integrates pre-designed assays with a database of more than 10,000 biological entities including genes, miRNAs, and pathways. The new advancements aim to support customers with a wide range of assay customization options, from simple to complex and validated multiplex assays, while further improving the user experience.

ELITechGroup is pleased to announce that they have obtained the IVDR certification for four new products including the brand new CMV RNA ELITe MGB Kit.

Point-of-care diagnostic firm Cue Health is laying off all of its employees and shuttering its operations.

The market for medical technology is innovative, dynamic, and growing. Bosch sees medical technology as a strategic growth field and intends to expand its Bosch Healthcare Solutions subsidiary, based in Waiblingen.

Oncocyte announced on Thursday that it has partnered with Bio-Rad Laboratories to globally commercialize the research-use-only GraftAssure assay.

Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its Mpox PCR Test Home Collection Kit to aid in the diagnosis of infection with non-variola Orthopoxvirus, including the monkeypox virus that causes monkeypox, also known as mpox. The test is the first mpox at-home collection kit authorized by FDA and is available to physicians to order for patients 18 years of age or older who are suspected of mpox infection.

French diagnostics firm BioMérieux said Wednesday that it has received 510(k) clearance from the US Food and Drug Administration for its BioFire SpotFire Respiratory/Sore Throat (R/ST) test panel.

Bio-Techne announced on Friday that its subsidiary Asuragen has received certification under Europe's In Vitro Diagnostic Regulation for its test to monitor chronic myeloid leukemia patients.

Fujirebio Europe has acquired the nonexclusive distribution rights to Self-screen's PreCursor-M AnoGyn assay in Europe, the Middle East, Africa, and Asia, the companies said on Tuesday.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the U.S. Food and Drug Administration (FDA) clearance for the NeuMoDx CT/NG Assay 2.0, growing its test menu for its integrated PCR-based clinical molecular testing systems NeuMoDx 96 and 288 in the United States.