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Molzyme Wins CE-IVD Marking for Pathogen Test

NEW YORK (GenomeWeb) – Molzym announced on Thursday that it has received CE-IVD marking for its Micro-Dx microbial DNA isolation and direct PCR test for routine pathogen diagnosis.

According to Molzym, the test involves automated human DNA removal and pathogen DNA enrichment from routine clinical samples such as fluid and tissue biopsies, combined with amplification and sequencing of parts of the 16S and 18S rRNA genes for the direct diagnosis of bacterial and fungal pathogens, respectively. Microbial DNA isolation is performed on the company's SelectNA plus instrument.

"The test is a means of rapid, non-targeted, and precise identification of microbial species without the need for cultivation," Molzym CEO Michael Lorenz said in a statement.

The firm said the test was launched for research use only in early 2016 but will be launched as a CE-IVD marked product next week.