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SpeeDx Mycoplasma Genitalium Kit Listed With FDA

NEW YORK (GenomeWeb) – The US Food and Drug Administration has listed SpeeDx's ResistancePlus MG Positive Control kit for sale in the US, the company said today.

The kit will be sold through SpeeDx's recently incorporated US entity. The Australian parent firm has also been registered with the FDA as a medical device manufacturing establishment. Clinical trials in the US for ResistancePlus MG remain on track, it said.

The kit contains synthetic DNA to simulate Mycoplasma genitalium and five mutations that are known to confer resistance to macrolide antibiotics. The assay received CE marking in 2016.