SpeeDx, a molecular diagnostics company, has received CE-IVD mark for sale of its ResistancePlus MG FleXible for the Cepheid GeneXpert System in Europe.

SpeeDx said that ResistancePlus MG FleXible is used in detecting the sexually transmitted infection (STI) Mycoplasma genitalium (Mgen) and markers associated with azithromycin resistance.

In addition, it marks the first test to be launched under collaboration of Cepheid and SpeeDx, to provide access to the GeneXpert sample-to-answer FleXible cartridge and is part of FleXible Cartridge programme.

SpeeDx CEOColin Denver said: “ResistancePlus MG FleXible represents both an evolution of our technology and of Resistance Guided Therapy for Mgen.

“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 Mgen infections.”

Cepheid to exclusively distribute ResistancePlus MG FleXible

SpeeDX said that Mgen could cause symptoms, including urethritis, cervicitis, endometritis and pelvic inflammatory disease, and is associated with reproductive health complications including pre-term birth and infertility.

In addition, Macrolide antibiotics, and azithromycin in particular, are used as the first-line treatment, but the resistance to antibiotics has increased up to 50% in several countries.

Alternative treatment options for the problem are limited and of which many are expensive, difficult to access, or associated with undesirable side-effects.

The Resistance Guided Therapy, through timely detection of antibiotic resistant infections, would result in better treatment of the disease for patients, reduced spread of infection.

Cepheid chief medical and technology officer David Persing said: “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.

“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.”