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SpeeDx Gets CE Mark for Antibiotic-Resistant STD MDx

NEW YORK (GenomeWeb) – Australian diagnostics firm SpeeDx has received CE marking for an assay to detect resistant strains of Mycoplasma genitalium, the company announced today.

The ResistancePlus MG assay detects M. genitalium as well as mutations in the bacterium's 23S rRNA that confer resistance to the macrolide drug azithromycin.

"As with the better known STD, gonorrhea, M. genitalium has developed serious treatment challenges because of the recent rise of antibiotic resistance," Colin Denver, SpeeDx's CEO, noted in a statement.

Although there is recent evidence M. genitalium infections are more prevalent than gonnorhea, infection is often misdiagnosed because symptoms resemble other STDs 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. European guidelines on Mycoplasma genitalium infections issued last month now recommend macrolide resistance testing, where available.

The ResistancePlus MG assay detects five SNPs that lead to resistance to the macrolide azithromycin, as previously reported, and the test was shown in a recent study to have high sensitivity and specificity.

SpeeDx plans to file a Premarket Approval application for the test with the US Food and Drug Administration in 2017, the firm said, noting that there are currently no approved molecular tests for M. genitalium in the US. The company has also entered into a Material Transfer Agreement with the US Centers for Disease Control and Prevention to evaluate the performance of the test.