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Anagnostics Gains CE-IVD Marks for Hybcell Array Sepsis, Drugs of Abuse Tests

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Austrian molecular diagnostics firm Anagnostics said this week that it has received CE-IVD approval for two tests based on its Hybcell cylindrical microarray platform.

The first test, called Hybcell Fungi DNA PlexA, can be used to detect roughly a dozen fungi associated with sepsis. Anagnostics said the test can be used in combination with its Hybcell Bacteria DNA PlexA test, which attained a CE-IVD mark in October 2012, and "perfectly complements [our] product portfolio in the area of integrated sepsis diagnostics."

The St. Valentin-based company's Hybcell Fungi DNA PlexA assay has a turnaround time of four hours and is run in conjunction with Molzym's SepsiTest sample preparation kit and a combination of PCR and on-array compact sequencing to detect and quantify pathogens in a blood sample. Anagnostics announced its relationship with Bremen, Germany-based Molzym two years ago.

Anagnostics has also garnered a CE-IVD mark for its Hybcell DoA Urine PlexC test. The assay allows simultaneous testing of 23 drug groups using minimal amounts of urine and can provide a comprehensive report within 17 minutes.

The firm has amassed a number of CE-IVD-marked tests for use on its Hyborg instrument, including panels for BRAF and KRAS mutation detection, inflammation monitoring, and drugs of abuse. All of its assays are run using Anagnostics' Hybcell technology. While most commercially available arrays are printed on slides, Anagnostics prints its Hybcell arrays on cylinders that are processed automatically in sample containers by the Hyborg instrument.

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