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Assays

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Assays

Enhancing cardiac care: FDA clearance for QuidelOrtho’s VITROS hs Troponin I Assay

The FDA has granted 510(k) clearance to QuidelOrtho for its VITROS hs Troponin I Reagent Pack, a test designed to detect cardiac troponin I levels in plasma, aiding in myocardial...
Nov. 4, 2025
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Assays

FDA 510(k)-cleared tacrolimus LC-MS/MS assay

Sept. 26, 2025
Courtesy of GMI
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Assays

Advancing precision medicine: How the apoptosis assay market is accelerating global research and safety

Aug. 22, 2025
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Assays

Quanterix launches novel p-Tau 205 and p-Tau 212 assays

Aug. 13, 2025
Courtesy of Roche
The cobas Respiratory 4-flex is used with the cobas 5800, 6800 and 8800 systems.
Assays

Roche's first respiratory test powered by TAGS technology receives FDA clearance for SARS-CoV-2, Influenza A, Influenza B and RSV

Aug. 6, 2025
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Assays

NeoGenomics announces PanTracer Tissue and PanTracer Tissue + HRD now available to support more informed and timely cancer care

July 3, 2025
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Assays

Foresight diagnostics presents independent validation of its CLARITY MRD assay in multicenter study of frontline DLBCL

May 27, 2025
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Assays

Roche receives FDA approval for the VENTANA MET (SP44) RxDx Assay as the first companion diagnostic to identify non-small cell lung cancer patients eligible for treatment with EMRELIS

May 19, 2025
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Implementation of POC hsTnI assay in the US

May 5, 2025

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Established in 1969, Medical Laboratory Observer (MLO) connects clinical laboratory professionals with peer-authored articles, continuing education (CE) courses, lab management tips, new testing techniques in molecular diagnostics, infection prevention, oncology and pathology practices, regulatory updates, industry trends, and new product reviews.
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