18 April 2019 - - Australia-based molecular diagnostics company SpeeDx Pty, Ltd has inked an agreement with molecular diagnostics company Cepheid to manufacture their ResistancePlus tests for use on the GeneXpert System, the companies said.

The first test in Cepheid's FleXible Cartridge programme, planned for launch early 2019, is ResistancePlus MG, detecting the sexually transmitted infection Mycoplasma genitalium (Mgen) and markers associated with azithromycin resistance.

Management guidelines for Mgen infection include resistance testing in response to rising rates of macrolide resistance observed with Mgen detection-only or empiric Mgen treatment.

ResistancePlus MG supports Mgen management guidelines and allows for Resistance Guided Therapy, which is clinically proven to improve cure rates by providing clinicians with much needed information to guide antibiotic treatment.

M. genitalium can cause symptoms such as urethritis, cervicitis, endometritis and pelvic inflammatory disease. In recent studies, it has been found to have a higher prevalence than gonorrhea. 

Like gonorrhea, M. genitalium is also evolving into a so-called STI superbug that is becoming resistant to many antibiotic treatments, leading to exceedingly difficult-to-treat infections and threatening global public health.

Macrolide antibiotics, specifically azithromycin, are the first-line treatment for the rapidly growing problem of M. genitalium STIs, but resistance to these antibiotics has increased up to 50% in several countries.

Due to this growing antibiotic resistance problem, several global STI Management Guidelines on Mgen Infections recommend complementing the use of molecular testing to detect M. genitalium with an assay capable of detecting macrolide resistance-associated mutations.

Currently, there is no FDA-cleared molecular diagnostic test for the detection of M. genitalium in the US.

The SpeeDx ResistancePlus MG assay is CE marked for sale in Europe and TGA approved for sale in Australia. The test provides valuable detection and antibiotic resistance information to clinicians in a rapid time frame.

Timely detection of antibiotic resistant infections enables Resistance Guided Therapy for better treatment of the disease for patients, lessening the potential for spreading among vulnerable populations and combating antibiotic resistance.

Founded in 2009, SpeeDx is an Australian-based private company with offices in London and the US, and distributors across Europe.

SpeeDx specialises in molecular diagnostic solutions that go beyond simple detection to offer comprehensive information for improved patient management. Real-time polymerase chain reaction technology has driven market-leading multiplex detection and priming strategies.

Product portfolios focus on multiplex diagnostics for sexually transmitted infection, antibiotic resistance markers, and respiratory disease.

Based in Sunnyvale, California, Cepheid is a molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests.

By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases.

Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer.