NEW YORK (GenomeWeb) – Australian diagnostics firm SpeeDx announced today that it has incorporated a US-based subsidiary as it plans for the US launch of its ResistancePlus MG assay for the detection of antibiotic-resistant strains of Mycoplasma genitalium.
The subsidiary is expected to be located in Austin, Texas, a company spokesperson said.
The ResistancePlus MG assay detects M. genitalium, as well as mutations in the bacterium's 23S rRNA that confer resistance to the macrolide drug azithromycin. It was CE marked last year and is being prepared for submission to the US Food and Drug Administration in partnership with Thermo Fisher Scientific.
“We have always had the goal of bringing ResistancePlus MG to the US market," SpeeDx CEO Colin Denver said in a statement. "Local offices and staff will allow us to more easily navigate the FDA approval process and keep us on track for our product launch next year."