Following initial clearance in March for detection and differentiation of carbapenemase genes in pure bacterial isolates, the latest clearance extends use of the assay to the analysis of direct rectal swab specimens.
Read MoreAgency allows marketing of the QuantideX qPCR BCR-ABL IS kit, the first nucleic acid-based quantitation test for use during treatment of rare leukemia.
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Keeping pace with emerging biomarkers, and consolidating a broad test menu, are both important for developing and updating immunoassay instruments and kits.
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The 84-gene panel is designed to identify patients with a genetic signature for inherited premature coronary or atherosclerotic disease, such as familial hypercholesterolemia, as well as mature onset diabetes of the young.
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The PGS test uses next-generation sequencing to support healthy pregnancies.
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