Diasorin (FTSE MIB: DIA) today announces the U.S. FDA approval of the LIAISON QuantiFERON-TB Gold Plus II assay as a next-generation automated Interferon Gamma Release Assay (IGRA) designed in partnership with QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) to enhance laboratory productivity, workflow efficiency and turnaround time for latent tuberculosis infection (LTBI) testing in the United States.
Meridian Bioscience, Inc., a leading global provider of diagnostic testing solutions and life science raw materials, today announced that a broad portfolio of its Alethia molecular assays has successfully achieved CE marking under the European In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746.
The U.S. Food and Drug Administration ("FDA") has granted QuidelOrtho Corporation (Nasdaq: QDEL) ("QuidelOrtho"), a global leader of in vitro diagnostics, 510(k) clearance for the VITROS hs Troponin I Reagent Pack (the "VITROS hs Troponin I Assay"). The assay is intended for the quantitative measurement of cardiac troponin I (cTnI) in human plasma (heparin) to aid in the diagnosis of myocardial infarction (MI).
Leinco Technologies, a leading global provider of in vitro diagnostic (IVD) raw materials, today announced the acquisition of BioClin, Inc.’s proprietary antibody clones used as IVD raw materials. This strategic partnership significantly expands Leinco’s portfolio of critical reagents for endocrine hormone research and diagnostic assays.
Illumina, Inc. (NASDAQ: ILMN) announced today it has entered into a definitive agreement with Standard BioTools (NASDAQ: LAB) under which Illumina will acquire SomaLogic, a leader in data-driven proteomics technology, and other specified assets for $350 million in cash payable at closing, subject to customary adjustments, plus up to $75 million in near-term performance-based milestones and performance-based royalties.
MRC Holland said Thursday that its blood-based assay for Temple, Kagami-Ogata, and Russell-Silver syndromes has received certification under Europe's In Vitro Diagnostic Regulation (IVDR).
Beckman Coulter Diagnostics, a global leader in advanced diagnostics, today announced availability of new Research Use Only (RUO) blood-based biomarker immunoassays designed to advance neurodegenerative disease research. These assays are intended to assess p-Tau217, GFAP, NfL, and APOE ε4 biomarkers, which are emerging as the most important biomarkers in neurodegenerative diseases research, including interventional clinical trials.
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received CE Mark for its VENTANA® FOLR1 (FOLR1-2.1) RxDx Assay. This is the first immunohistochemistry (IHC) companion diagnostic test to be made widely available in Europe to aid in identifying epithelial ovarian cancer (EOC) patients who may be eligible for targeted treatment with ELAHERE® (mirvetuximab soravtansine). ELAHERE is a first-in-class antibody-drug conjugate (ADC) therapy developed by AbbVie for the treatment of FRɑ-positive platinum-resistant ovarian cancer.
BioMérieux reported Thursday that its second quarter revenues rose 8 percent year over year due in part to strong sales of BioFire assays.
QuidelOrtho announced Thursday that its Vitros syphilis assay has received 510(k) clearance from the US Food and Drug Administration and is now available globally.
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