Clinical data demonstrates significantly increased cure rates using Resistance Guided Therapy for treating the STI Superbug M. genitalium

SpeeDx ResistancePlus® MG test supports new STI management guidelines

SYDNEY, Australia, June 21, 2018 (GLOBE NEWSWIRE) -- SpeeDx Pty. Ltd. today announced clinical data contained in a new study published in the June 2018 issue of Clinical Infectious Diseases¹ [link] supports the use of Resistance Guided Therapy for more effective treatment of Mycoplasma genitalium infections. Using the SpeeDx ResistancePlus® MG test, the authors recorded an overall cure rate of >92%, a significant increase compared with previous cure rates of 67% prior to using Resistance Guided Therapy.ResistancePlus MG test simultaneously detects the sexually transmitted infection (STI) M. genitalium and the genetic markers linked to antimicrobial resistance (AMR).

The test is CE marked and in use across Europe, and available in laboratories across Australia and New Zealand. Clinical trials are underway in the U.S. in preparation for de novo clearance for the test with the U.S. Food and Drug Administration. 

"This is a seminal publication demonstrating a remarkable improvement in treating what has essentially become an STI superbug," said Colin Denver, SpeeDx CEO. "Using diagnostics to define appropriate treatment decisions is key when dealing with the global health threat of antimicrobial resistance."

Senior study author Associate Professor Catriona Bradshaw has worked on M. genitalium for 15 years. "I've seen resistance to azithromycin, the frontline recommended treatment for M. genitalium infection, rise to over 50% in Melbourne over the last decade," she said. "Unfortunately, it's now a situation mirrored in many countries around the world."¹

Within the context of high level resistance and ongoing use of azithromycin - which helps to further increase macrolide resistance - the team developed a three-tier treatment pathway. The first step was switching from azithromycin to doxycycline for initial treatment, and then using the ResistancePlus MG test to detect macrolide resistance biomarkers. If macrolide resistance was detected, patients were treated with a quinolone antibiotic (sitafloxacin) to avoid unnecessary and ineffective use of azithromycin. If macrolide resistance was not detected, the patient was given a higher than standard dose of azithromycin over 4 days to reduce the development of de novo resistance.