Australian-based diagnostic firm SpeeDx has established a U.S.-based subsidiary company by the same name. SpeeDx develops multiplex molecular diagnostics and will use its U.S. base to support clinical trials for its test ResistancePlus MG in preparation for an expected 2018 launch in the U.S. The ResistancePlus MG test detects the sexually transmitted bacteria Mycoplasma genitalium along with mutations that confer resistance to azithromycin, the front-line antibiotic treatment for this pathogen. “We have always had the goal of bringing ResistancePlus MG to the U.S. market,” said Colin Denver, CEO of SpeeDx. “Local offices and staff will allow us to more easily navigate the [Food and Drug Administration (FDA)] approval process and keep us on track for our product launch.”
In early 2017, SpeeDx also entered a partnership with Thermo Fisher focused on obtaining FDA authorization for the ResistancePlus MG. The test has already received regulatory clearances in Europe, Australia, and New Zealand.