SpeeDx’s ResistancePlus MG Positive Control kit has now been listed with the US Food and Drug Administration (FDA) for sale in the United States. The ResistancePlus MG Positive Control kit contains synthetic DNA to simulate Mycoplasma genitalium, as well as five mutations known to confer resistance to macrolide antibiotics.
Macrolide-resistant M. genitalium is a challenging sexually transmitted infection (STI), and global management guidelines are currently being adapted to deal with the rise in resistance. “This is an important product in our portfolio,” said Elisa Mokany, Chief Technology Officer for SpeeDx. “M. genitalium is very difficult to culture, and positive material for quality control can be hard to come by.”
SpeeDx’s ResistancePlus MG assay is the first commercially available diagnostic test that simultaneously detects M. genitalium and genetic markers for antimicrobial resistance, and has been widely adopted across Europe, Australia and New Zealand since gaining CE marking in 2016. “We have a strong focus on tackling the global antimicrobial resistance problem,” said Colin Denver, CEO of SpeeDx. “STIs are set to become the first incurable bacterial infections, and our ResistancePlus line of diagnostic tests empowers clinicians to make informed treatment decisions.”