SpeeDx Pty Ltd, Sydney, Australia, recently announced the incorporation of a US-based subsidiary company, SpeeDx Inc. The parent company will use its US base to support current clinical trial activity for the ResistancePlus MG test, in preparation for an expected 2018 launch in the United States.
The SpeeDx ResistancePlus MG test detects the sexually transmitted bacterium Mycoplasma genitalium along with mutations that confer resistance to azithromycin, the frontline antibiotic treatment of choice.
The test has previously received regulatory clearances in Australia, Europe, and New Zealand, and is already experiencing strong sales in those locations. SpeeDx recently signed a partnership agreement with Thermo Fisher Scientific, Waltham, Mass, to help bring the ResistancePlus MG test to the United States. The company also has an agreement with Cepheid for distribution of its PlexPCR and ResistancePlus tests in Europe.
Colin Denver, SpeeDx.
“We have always had the goal of bringing ResistancePlus MG to the US market,” says Colin Denver, CEO of SpeeDx. “Local offices and staff will allow us to more easily navigate the FDA approval process and keep us on track for our product launch [this] year.”
A sharp rise in resistant strains of M. genitalium across the globe has led to international guidelines for the management of M. genitalium infections that recommend testing for macrolide resistance to better inform treatment options.1 With the US prevalence of M. genitalium rapidly increasing—and in some instances exceeding that of chlamydia—it is expected that US guidelines will also be updated to address antimicrobial resistance in this sexually transmitted disease.2
“Our aim is to empower clinicians and physicians to make the best treatment decisions about the diseases they are faced with,” says Denver. “Ultimately, we want to support individualized patient management and better antimicrobial stewardship, which will help patients quickly receive the best treatment for their disease, and for physicians to better address antibiotic resistance challenges.”
REFERENCES
- Jensen JS, Cusini M, Gomberg M, et al. 2016 European guideline on Mycoplasma genitalium infections. JEADV. 2016;30(10):1650–1656; doi: 10.1111/jdv.13849.
- Getman D, Jiang A, O’Donnell M, et al. Mycoplasma genitalium prevalence, coinfection, and macrolide antibiotic resistance frequency in a multicenter clinical study cohort in the United States. J Clin Microbiol. 2016;54(9):2278–2283; doi: 10.1128/JCM.01053-16.
