Subsidiary prepares for expected 2018 US product launch
SYDNEY, Australia, Dec 5 (Bernama-GLOBE NEWSWIRE) -- 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), in preparation for an expected 2018 launch. The SpeeDx ResistancePlus™ MG test detects the sexually transmitted bacteria Mycoplasma genitalium along with mutations that confer resistance to azithromycin, the front-line antibiotic treatment of choice.
ResistancePlus™ MG will potentially be a first-to-market molecular diagnostic test in the US, providing both detection of the MG infection along with information about antibiotic resistance of the disease. The test previously received regulatory clearances in Europe, Australia and New Zealand and is already experiencing strong sales in those locations. SpeeDx recently signed a partnership agreement with Thermo-Fisher to help bring the ResistancePlus™ MG test to the US and a distribution agreement with Cepheid in Europe for their PlexPCR™ and ResistancePlus™ tests.
SYDNEY, Australia, Dec 5 (Bernama-GLOBE NEWSWIRE) -- 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), in preparation for an expected 2018 launch. The SpeeDx ResistancePlus™ MG test detects the sexually transmitted bacteria Mycoplasma genitalium along with mutations that confer resistance to azithromycin, the front-line antibiotic treatment of choice.
ResistancePlus™ MG will potentially be a first-to-market molecular diagnostic test in the US, providing both detection of the MG infection along with information about antibiotic resistance of the disease. The test previously received regulatory clearances in Europe, Australia and New Zealand and is already experiencing strong sales in those locations. SpeeDx recently signed a partnership agreement with Thermo-Fisher to help bring the ResistancePlus™ MG test to the US and a distribution agreement with Cepheid in Europe for their PlexPCR™ and ResistancePlus™ tests.
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