Tag Archives: SpeeDx

August 2019—SpeeDx Pty. announced that the FDA has granted breakthrough device designation for its ResistancePlus GC, a molecular test providing ciprofloxacin susceptibility and resistance information to effectively treat N. gonorrhoeae. It is CE marked and cleared by the Therapeutic Goods Association for use in Europe, Australia, and New Zealand.

July 2018—SpeeDx’s ResistancePlus MG Positive Control kit has been cleared by the FDA.

February 2018—SpeeDx announced it has received CE-IVD marking for its PlexPCR VHS multiplex qPCR test. The test offers a single-well solution to cover the detection and differentiation of the main causes of genital and oral lesions—herpes simplex virus types 1 and 2, Treponema pallidum (syphilis), and varicella zoster virus.

July 2017—SpeeDx announced an agreement with Cepheid for distribution of its PlexPCR and ResistancePlus molecular diagnostic products in key markets throughout Europe. The agreement, covering Germany, France, Italy, and the U.K., will increase coverage for the ResistancePlus MG test, a CE-IVD test for the sexually transmitted infection Mycoplasma genitalium that combines detection with testing for azithromycin resistance.

October 2016—SpeeDx Pty, Ltd., featured its PlexPCR for the detection of infectious disease pathogens and the ResistancePlus multiplex qPCR test for the detection of Mycoplasma genitalium and antimicrobial resistance markers.

September 2016—SpeeDx received CE-IVD marking for its PlexPCR HSV-1&2, VZV multiplex qPCR kit. The multiplex molecular diagnostic test offers a single-well solution to cover the detection and differentiation of three herpes viruses (HSV-1, HSV-2, VZV) in addition to an internal control.