SpeeDx and Thermo Fisher Scientific have partnered to bring to U.S. markets a molecular diagnostic test for Mycoplasma genitalium (M. genitalium), a treatment-resistant and rapidly growing sexually transmitted infection (STI). Under the terms of the partnership, SpeeDx will submit its ResistancePlus MG test to the Food and Drug Administration (FDA) for approval. The diagnostic would then be available for use with Thermo Fisher’s Applied Biosystems 7500 Fast Dx Real-Time PCR system.
The test consists of a multiplex quantitative polymerase chain reaction assay that detects M. genitalium from urine and swab specimens. Additionally, it identifies any mutations in the bacteria’s 23S rRNA gene that could confer resistance to azithromycin by detecting five macrolide resistance markers. M. genitalium infections are usually treated with first-line macrolide antibiotics such as azithromycin, but resistance to this treatment has significantly increased in multiple countries. The European Guideline on M. genitalium infections recommended last year that molecular detection of the bacteria should be complemented with identification of macrolide resistance-associated mutations.
Currently SpeeDx markets the diagnostic in Europe, Australia, and New Zealand. If approved by FDA, it would be the first molecular diagnostic test for the detection of M. genitalium in the U.S.