MinuteClinics and Axis-Shield Ink Agreement to Provide Point-of-Care Hemoglobin A1c Tests in 600 CVS Pharmacies

Retail clinics ready to expand into chronic disease management and that can be a threat or an opportunity for clinical laboratories Dark Daily has often predicted that rapid clinics in retail stores would actively look for opportunities to add specific medical laboratory tests to their on-site service menus. Now the largest retail clinic in the U.S. is set to deploy hemoglobin A1c (HbA1c) testing analyzers in its 600 retail clinic sites throughout the United States. This deal was announced in...

FDA Gets an Earful During Public Meeting on Guidance Document for IVD-MIAs

Yesterday’s public forum conducted by the Food and Drug Administration (FDA) on proposed guidance to regulate a certain category of molecular diagnostic assays drew a surprisingly large and diverse number of presentations and comments from the laboratory, biotech, and healthcare industries. When the FDA recently released two draft guidelines, one for commercially distributed analyte specific regents (ASRs) and another for IVD multivariate index assays (IVD-MIAs), it was hoping to address...
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