SpeeDx Prepare for US Launch of ResistancePlus™ MG
8 Dec 2017
SpeeDx Pty. Ltd, a developer of advanced multiplex molecular diagnostic solutions, announced the incorporation of a US-based subsidiary company, SpeeDx Inc. The parent company, headquartered in Australia, will use the US base to support current clinical trial activity for ResistancePlus™ MG (not currently for sale in the US), in preparation for an expected 2018 launch. The SpeeDx ResistancePlus™ MG test detects the sexually transmitted bacteria Mycoplasma genitalium along with mutations that confer resistance to azithromycin, the front-line antibiotic treatment of choice.
ResistancePlus™ MG will potentially be a first-to-market molecular diagnostic test in the US, providing both detection of the MG infection along with information about antibiotic resistance of the disease. The test previously received regulatory clearances in Europe, Australia and New Zealand and is already experiencing strong sales in those locations. SpeeDx recently signed a partnership agreement with Thermo-Fisher to help bring the ResistancePlus™ MG test to the US and a distribution agreement with Cepheid in Europe for their PlexPCR™ and ResistancePlus™ tests.
“We have always had the goal of bringing ResistancePlus MG to the US market”, said 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 next year.”
A rapid 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. With M. genitalium prevalence rapidly increasing in the US, and in some instances exceeding that of Chlamydia, it is expected that US guidelines will also be updated to address antimicrobial resistance in this significant sexually transmitted disease (STD).
“Our aim is to empower clinicians and physicians to make the best treatment decisions about the diseases they are faced with,” said Colin 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.”