NEW YORK (GenomeWeb) – Australian diagnostics firm SpeeDx has partnered with Thermo Fisher Scientific to obtain US Food and Drug Administration approval for its ResistancePlus MG assay for antibiotic-resistant Mycoplasma genitalium, the companies announced today.
The assay detects M. genitalium, as well as mutations in the bacterium's 23S rRNA that confer resistance to the macrolide drug azithromycin. It received CE marking in September.
Under the terms of the deal, SpeeDx will submit the test to the FDA after it is successfully validated for use on the Applied Biosystems 7500 Fast Dx Real-Time-PCR system. Additional terms were not disclosed.
"We developed our diagnostic test to answer the immediate need for detection and resistance screening for this difficult to manage" sexually transmitted infection, SpeeDx CEO Colin Denver said in a statement. "Applied Biosystems qPCR instrumentation has a long-standing reputation for quality and a wide install base across the region."
Although there is recent evidence M. genitalium infections are more prevalent than gonorrhea, infection is often misdiagnosed because symptoms resemble other sexually transmitted diseases and PCR testing is not widely available. Patients are typically given broad-spectrum antibiotics, but the prevalence of resistant strains can be as high as 50 percent in some settings.