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GenMark Diagnostics Obtains FDA Clearance for Gram-Negative Sepsis Panel

Apr 15, 2019
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staff reporter

NEW YORK (GenomeWeb) - GenMark Diagnostics said today it has received 510(k) clearance from the US Food and Drug Administration for a panel assay to detect gram-negative bacteria in blood cultures.

The ePlex Blood Culture Identification Gram-Negative (BCID-GN) Panel detects 21 gram-negative bacteria, six resistance genes, and pan targets for gram-positive organisms and Candida, according to the firm's website. It completes GenMark's suite of multiplex panels to detect bloodstream infections that can cause sepsis, the firm said in a statement.

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