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NeuMoDx T. Vaginalis, M. Genitalium Assay CE Marked

NEW YORK – NeuMoDx Molecular said on Friday that it received CE-IVD marking for its assay to detect and differentiate Trichomonas vaginalis and/or Mycoplasma genitalium in clinical urine samples.

The Ann Arbor, Michigan-based company has launched the assay, which is for use with NeuMoDx Molecular systems. The assay leverages nucleic acid amplification technology for the automated detection of T. vaginalis and M. genitalium simultaneously.

"Laboratories around the world will be able to deliver high-quality results to clinicians and the patients they serve in a more rapid and efficient manner," NeuMoDx CEO Jeff Williams said in a statement.

Under a merger agreement with Qiagen reached in September 2018, the two firms aimed to develop a test menu that would allow them to compete with other companies in the high-volume molecular testing space. The menu included a test for T. vaginalis.