Skip to main content
Premium Trial:

Request an Annual Quote

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

Premium

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.

The Scan

Researchers Compare WGS, Exome Sequencing-Based Mendelian Disease Diagnosis

Investigators find a diagnostic edge for whole-genome sequencing, while highlighting the cost advantages and improving diagnostic rate of exome sequencing in EJHG.

Researchers Retrace Key Mutations in Reassorted H1N1 Swine Flu Virus With Avian-Like Features

Mutations in the acidic polymerase-coding gene boost the pathogenicity and transmissibility of Eurasian avian-like H1N1 swine influenza viruses, a PNAS paper finds.

Genome Sequences Reveal Evolutionary History of South America's Canids

An analysis in PNAS of South American canid species' genomes offers a look at their evolutionary history, as well as their relationships and adaptations.

Lung Cancer Response to Checkpoint Inhibitors Reflected in Circulating Tumor DNA

In non-small cell lung cancer patients, researchers find in JCO Precision Oncology that survival benefits after immune checkpoint blockade coincide with a dip in ctDNA levels.