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GenoScreen Gets CE-IVD Mark for Tuberculosis Test

NEW YORK — French biotechnology firm GenoScreen said on Monday that it has received CE-IVD marking for its Deeplex Myc-TB kit for the prediction of tuberculosis antibiotic susceptibility and resistance.

According to the company, the test uses next-generation sequencing to analyze 23 genetic regions of Mycobacterium tuberculosis and other mycobacteria to detect mutations that cause resistance to 15 first- and second-line antibiotics, as well as to identify the bacterium. It can be used on uncultured clinical samples and provides results in less than 48 hours via a web-based application.

Deeplex Myc-TB was already available for research use only in various European, African, and Asia markets, GenoScreen said.