NEW YORK (GenomeWeb News) – Molecular diagnostics company AdvanDx announced today that it has received clearance from the US Food and Drug Administration for a 90-minute version of its peptide nucleic acid fluorescence in situ hybridization (PNA FISH) test for the bloodstream pathogen Enterococcus faecalis.

AdvanDx secured FDA 510(k) clearance for the test, which is faster than the existing two-and-a-half hour E. faecalis PNA FISH test but appears to have similar sensitivity and specificity, based on clinical validation studies in the US and Europe.

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Apr
29
Sponsored by
Covance

This online seminar will review case studies demonstrating the clinical utility of CTCs and cfDNA to define and characterize a variety of dynamic genomic changes throughout the course of cancer detection and treatment.