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In Brief This Week: Burst Diagnostics, Agilent, Abbott, DermTech, Biocept, More
News items for the week of Sept. 18, 2023
BioMérieux Submits Dual FDA Marketing, CLIA Waiver Application for Respiratory, Sore Throat Panel
The French diagnostics maker is seeking both 510(k) clearance and a CLIA waiver for the multiplex PCR test, which can be used at the point of care.
Invitae Publishes First Validation Data on MRD Assays, Laying Path to Future Clinical Expansion
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The analytical validity study is the first published featuring full performance data for the firm's Personalized Cancer Monitoring technology.
Euformatics Forms Distribution Partnership for Eastern Europe With Bulgaria's Elta 90
The bioinformatics firm will sell its Genomics Hub software to labs and research institutes in Romania, North Macedonia, and Moldova through a local partner.
Diagnostic Companies Aim to Bring Routine Testing to Point of Care, but Face Significant Hurdles
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The Theranos scandal still hangs over the space, but several firms are working to move miniaturized clinical analyzers into settings like doctors' offices.
Sep 13, 2023