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NEW YORK (GenomeWeb) – GenMark Diagnostics announced today it has received 510(k) clearance from the US Food and Drug Administration for a molecular diagnostic panel assay to detect fungal pathogens from blood cultures of patients with suspected bloodstream infections. 

The test is called the ePlex Blood Culture Identification Fungal Pathogen (BCID-FP) Panel. It runs on the firm's ePlex system, which utilizes microfluidics-based DNA hybridization to signal and capture probes as well as electrochemical detection technologies.

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