At the 2016 annual meeting of the American Association for Clinical Chemistry, in Philadelphia, SpeeDx Pty Ltd, Sydney, Australia, is featuring its PlexPCR kit for the detection of infectious disease pathogens and its unique ResistancePlus MG multiplex, real-time polymerase chain reaction (qPCR) test for the detection of Mycoplasma genitalium and antimicrobial resistance markers.
ResistancePlus MG is the first qPCR test to combine M. genitalium identification and information on macrolide antibiotic resistance. SpeeDx expects to receive the CE mark for the test in August 2016. In the United States, the test kit is available for research use only; it is not for sale in the United States for diagnostic applications.
“This is an exciting time for SpeeDx, with a number of recent positive developments,” says Colin Denver, CEO of SpeeDx. Recent achievements for the company have included:
- Publication of a ResistancePlus MG study showing strong results in the detection of both M. genitalium and mutations shown to confer resistance to macrolide-based antibiotics.1
- CE marking of the PlexPCR HSV 1/2 and VZV kit.
- Establishment of a European subsidiary, SpeeDx Ltd, headquartered in the London Bioscience Innovation Center.
- Partnership with Goffin Molecular Technologies to support European sales and marketing efforts.
During the AACC meeting, Alison Todd, PhD, SpeeDx founder and chief scientific officer, will present a scientific poster, “A qPCR assay that simultaneously detects Mycoplasma genitalium and mutations associated with macrolide resistance has the potential to improve patient management” (Poster B-065; Wednesday, August 3).
M. genitalium is a sexually transmitted infection that can cause symptoms including urethritis, cervicitis, and pelvic inflammatory disease. In the general population, the prevalence of M. genitalium ranges from 1% to 3%. In higher risk populations it ranges from 10% to 40%, often exceeding the prevalence of Neisseria gonorrhoeae.
M. genitalium infection has been largely underreported due to the difficulty of isolating and culturing the organism, which can take months. This difficulty means that molecular testing is the only practical method of reliably identifying M. genitalium. Antibiotic resistance to the recommended antimicrobial treatment, azithromycin, is rapidly emerging. Various government initiatives have focused on increasing the development and use of rapid molecular diagnostic tests for identifying infections and also characterizing the presence of any resistant bacteria.
PlexPCR and ResistancePlus constitute multiplex qPCR kits for the detection of infectious disease pathogens and antimicrobial resistance markers, respectively. Powered by SpeeDx’s proprietary PlexZyme and PlexPrime technologies, both product lines offer high multiplexing capability for better, more streamlined infectious disease management. With increased ability to detect more pathogens, as well as multiple genetic markers, every PlexPCR and ResistancePlus test provides more actionable information for laboratories and clinicians.
For more information, visit SpeeDx at AACC booth 358 or online at SpeeDx.
- Tabrizi SN, Tan LY, Walker S, et al. Multiplex assay for simultaneous detection of Mycoplasma genitalium and macrolide resistance using PlexZyme and PlexPrime Technology. PLoS One. 2016;11(6): e0156740; doi: 10.1371/journal.pone.0156740.