SpeeDx and Thermo Fisher Scientific Partner for FDA Clearance of Molecular Diagnostic Test
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SpeeDx Pty. Ltd. has signed an agreement with Thermo Fisher Scientific. The announcement was made at the 27th European Congress of Clinical Microbiology and Infectious Disease (ECCMID) in Vienna to submit its ResistancePlus MG Test for the detection of Mycoplasma genitalium to the US Food & Drug Administration (FDA).
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.”
”We are proud to be partnering with SpeeDx to enable them to bring their diagnostic test to the U.S. market,” said Kim Kelderman, vice president and general manager, Genetic Analysis, at Thermo Fisher Scientific. “We are committed to working with diagnostic partners around the world who share our vision of driving better health outcomes by using precision medicine.”