SYDNEY, Australia, Dec. 6 (Korea Bizwire) — SpeeDx Pty. Ltd. announced today it has received CE-IVD marking for its ResistancePlus® GC assay that detects both the sexually transmitted infection (STI) N. gonorrhoeae, and sequences in the gyrA gene of the bacteria associated with susceptibility to ciprofloxacin (Cipro), a previously used front-line antibiotic treatment. Currently, ceftriaxone [...]
SYDNEY, Australia, Nov. 8 (Korea Bizwire) — SpeeDx have announced the signing of a further four distribution partners, in preparation to strengthen representation across Europe. Axonlab (Germany, Benelux and Switzerland), Vircell (Spain), Diamedica (Estonia, Latvia, and Lithuania) and Biomedica (Central Eastern Europe) each have a strong presence in their chosen markets and synergies with the [...]
SYDNEY, Australia, Sept. 25 (Korea Bizwire) — SpeeDx Pty. Ltd. today announced the start of patient testing in their multisite U.S.-based clinical trials for ResistancePlus® MG (not available for sale in the U.S.). The molecular diagnostic test detects the sexually transmitted infection (STI) Mycoplasma genitalium, also known as Mgen or MG, along with genetic markers [...]
SYDNEY, Australia, Apr. 19 (Korea Bizwire) — SpeeDx’s ResistancePlus® MG Positive Control kit has now been listed with the US Food and Drug Administration (FDA) for sale in the United States through the company’s recently incorporated US entity, SpeeDx Inc. The announcement coincides with the FDA registration of the Australian parent company – SpeeDx Pty [...]
SYDNEY, Australia, Dec. 4 (Korea Bizwire) — SpeeDx Pty. Ltd, a developer of advanced multiplex molecular diagnostic solutions, announced the incorporation of a US-based subsidiary company, SpeeDx Inc. The parent company, headquartered in Australia, will use the US base to support current clinical trial activity for ResistancePlus™ MG (not currently for sale in the US), [...]