NEW YORK – SpeeDx announced today it has received CE-IVD mark for its test for the sexually transmitted infection Mycoplasma genitalium and antibacterial resistance determination on the Cepheid FleXible cartridge.
The test, called the ResistancePlus MG Flexible cartridge, detects M. gen as well as five genetic markers associated with resistance to the macrolide antibiotic azithromycin.
It is the first assay to be launched under Cepheid's FleXible cartridge program, and the first near-patient test to support so-called resistance-guided therapy for M. gen.
"There is considerable interest by clinicians and laboratories alike, as it will now be even easier to adhere to international and local management guidelines and provide clinically relevant and timely information to manage the growing problem of macrolide resistance in M. gen infections," said Colin Denver, CEO of Sydney, Australia-based SpeeDx, in a statement.
David Persing, chief medical and technology officer at Cepheid, said that SpeeDx offers unique technology for simultaneous detection of pathogens and drug resistance directly from clinical specimens.
"Together, we have leveraged the open architecture of our new FleXible cartridge to enable detection of this emerging drug-resistant pathogen on the GeneXpert System," Persing said, adding, "The ResistancePlus MG Flexible cartridge offers best-in-class performance in an easy to use, on-demand format to address a significant medical need in symptomatic individuals, and adds to the growing portfolio of STI testing options available on our platform.”
About half of all M. gen infections are macrolide-resistant globally, and current guidelines in Europe, the UK, and Australia suggest resistance testing of M. gen infections to guide effective therapy and reduce selective pressure on the bacteria.
In the US, lab-based assays for detection of M. gen from Hologic and Roche were recently cleared by the US Food and Drug Administration, and SpeeDx is also in the process of submitting its open-platform M. gen assay kit that also detects resistance.