Speedx ontvangt ce-ivd goedkeuring yeast infection from antibiotics voor resistanceplus mg flexible novumpr

SYDNEY-(BUSINESS WIRE)- speedx pty, ltd. Kondigde vandaag aan dat resistanceplus® MG flexible voor het cepheid genexpert® systeem, dat de seksueel overdraagbare infectie (STI) mycoplasma genitalium (mgen) en markers die geassocieerd worden met de resistentie tegen azithromycine yeast infection from antibiotics detecteert, een CE-IVD-markering heeft gekregen voor verkoop in europa. Dit is de eerste test die wordt gelanceerd in het yeast infection from antibiotics kader van het flexible cartridge-programma van cepheid, in samenwerking met speedx – een betrouwbare testfabrikant – om toegang te bieden tot de genexpert sample-to-answer flexible-cartridge.

SYDNEY–(BUSINESS WIRE)– speedx pty, ltd. Today announced resistance plus® MG flexible for the cepheid genexpert® system, detecting the sexually transmitted infection (STI) mycoplasma genitalium (mgen) and markers associated with azithromycin resistance, received CE-IVD mark for sale in europe. This is the first test to be launched under cepheid’s flexible cartridge programme, partnering with speedx – a trusted assay manufacturer – to provide access to the genexpert sample-to-answer flexible cartridge.

ResistancePlus MG flexible simultaneously detects M. Genitalium (mgen) and macrolide resistance. SpeeDx, a trusted assay manufacturer, has partnered with cepheid to provide resistance guided therapy for yeast infection from antibiotics mgen on the genexpert sample-to-answer flexible cartridge. (photo: business wire)

“resistanceplus MG flexible represents both an evolution of our technology yeast infection from antibiotics and of resistance guided therapy for mgen”, said colin denver speedx CEO. “there is considerable interest by clinicians and laboratories alike, as it will now be even easier to adhere to yeast infection from antibiotics international and local management guidelines and provide clinically relevant and yeast infection from antibiotics timely information to manage the growing problem of macrolide resistance yeast infection from antibiotics in mgen infections.”

Mgen can cause symptoms such as urethritis, cervicitis, endometritis and pelvic inflammatory disease, and has been linked to reproductive health complications including pre-term birth and infertility. 1,2 macrolide antibiotics, specifically azithromycin, are the first-line treatment for the rapidly growing problem of mgen, but resistance to these antibiotics has increased up to 50% in several countries. 4-6 there are limited alternative treatment options, many of which are expensive, difficult to access, or associated with undesirable side-effects. 4,5 current mgen guidelines focus on extending the utility of yeast infection from antibiotics azithromycin by testing for macrolide resistance-associated mutations and stratifying patient treatment accordingly. 1-3

“speedx offers unique technology for simultaneous detection of pathogens and yeast infection from antibiotics drug resistance directly from clinical specimens. Together, we have leveraged the open architecture of our new flexible yeast infection from antibiotics cartridge to enable detection of this emerging drug-resistant pathogen on the genexpert system,” said david H. Persing, M.D., ph.D., cepheid’s chief medical and technology officer. “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 yeast infection from antibiotics individuals, and adds to the growing portfolio of STI testing options yeast infection from antibiotics available on our platform.”

Timely detection of antibiotic resistant infections enables resistance guided therapy, resulting in better treatment of the disease for patients, reduced potential for spreading infection among vulnerable populations, and supporting antibiotic stewardship to combat rising antibiotic resistance.

SpeeDx has developed a molecular diagnostics test portfolio, principally for infectious diseases, that provides both identification as well as therapeutic guidance capabilities. The company is based in australia with offices in austin yeast infection from antibiotics and london, and distributors across europe. SpeeDx specializes in molecular diagnostic solutions that go beyond simple yeast infection from antibiotics detection to offer comprehensive information for improved patient management. The speedx resistance plus® MG open-platform assay is CE marked for sale in europe, TGA approved for sale in australia and clinical trials are yeast infection from antibiotics being finalised for submission to the U.S. FDA. Products in the speedx portfolio focus on multiplex diagnostics for yeast infection from antibiotics sexually transmitted infection (STI), antibiotic resistance markers, and respiratory disease.