15th May 2017 Content supplied by: SpeeDx
SpeeDx and Thermo Fisher Partner for FDA Submission of ResistancePlus MG
SpeeDx Pty. Ltd. has signed an agreement with Thermo Fisher Scientific to submit its ResistancePlus MG Test for the detection of Mycoplasma genitalium to the US Food & Drug Administration (FDA), the announcement was made at the recent 27th European Congress of Clinical Microbiology and Infectious Disease (ECCMID) in Vienna.
Following ongoing validity, SpeeDx will submit the test for use with the Applied Biosystems 7500 Fast Dx Real-Time PCR System. The ResistancePlus MG Test is designed to identify both M. genitalium and mutations in the 23S rRNA gene of the bacteria that have been shown to confer resistance to azithromycin, a commonly prescribed macrolide-based antibiotic. The test has previously received a CE mark, accreditation by the Australian Therapeutic Goods Administration (TGA), and is already marketed across Europe, Australia and New Zealand.
“We developed this diagnostic test to address an immediate need for detection and resistance screening for this difficult to manage STI,” said Colin Denver, CEO of SpeeDx. “With its reputation for scientific excellence, we are very pleased to partner with Thermo Fisher to bring this test to the US market. Applied Biosystems qPCR instrumentation has a long-standing reputation for quality, and a wide install base across the region.”
Date Published: 15th May 2017
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