SpeeDx Pty. Ltd. have announced the start of patient testing in their multisite U.S.-based clinical trials for ResistancePlus® MG (not available for sale in the U.S.). The molecular diagnostic test detects the sexually transmitted infection (STI) Mycoplasma genitalium, also known as Mgen or MG, along with genetic markers linked to antibiotic resistance. In recent years, Mgen prevalence has increased globally and developed high rates of resistance to the frontline antibiotic treatment, azithromycin.
"This test is an exciting new development that will increase the precision of patient care for patients impacted by Mycoplasma genitalium - a common sexually transmitted infection with limited treatment options,” notes Doctor Maria Trent, Professor of Pediatrics and Public Health at Johns Hopkins Medicine.
The SpeeDx ResistancePlus MG test is in use in laboratories across Europe, U.K., Australia, and New Zealand. However, in the U.S., there is currently not a Food and Drug Administration-cleared commercially available test for Mgen. SpeeDx is expecting clearance of ResistancePlus MG in 2019 with U.S. clinical trials now beginning at the University of Alabama at Birmingham, Johns Hopkins University, and TriCore Reference Laboratories.
“This is an important new test that has now influenced Mgen treatment guidelines in Europe, the UK, and Australia,” said Colin Denver, CEO of SpeeDx. “We are delighted with the progress of our U.S. clinical trial sites and we are excited to be able to offer the test in the U.S. market in the near future.”
In a recent peer-reviewed study published in Clinical Infectious Diseases last month, the authors recorded an overall cure rate of >92% when using Resistance Guided Therapy with the ResistancePlus MG test - a significant increase compared with previous cure rates below 60%. Resistance to azithromycin, the frontline recommended treatment for M. genitalium infection, has risen to over 50% in many countries around the world. Data from this study has already influenced recent STI management guideline updates in Australia and the United Kingdom, with recommendations to assess the resistance status of M. genitalium infections in order to guide appropriate treatment. Using diagnostics to define appropriate treatment decisions results in a more effective use of antibiotics, curtails the use of inappropriate prescribing and helps preserve the use of key medicines needed to combat the global rise of antimicrobial resistance.