SpeeDx and Thermo Fisher Scientific Announce Strategic Partnership for FDA Clearance of Molecular Diagnostic.
ResistancePlus™ MG Test would bring disease and antibiotic resistance testing to U.S. market for sexually transmitted infection and potential “superbug”
Under the terms of the agreement, SpeeDx will submit the test to the FDA upon successful validation for use with the Applied Biosystems 7500 Fast Dx Real-Time PCR System to detect M. genitalium, a rapidly growing sexually transmitted infection (STI) that has developed significant resistance to first-line antibiotic treatment and threatens to become a potential “superbug.” The announcement was made at the 27th European Congress of Clinical Microbiology and Infectious Disease (ECCMID) in Vienna.
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 now marketed across Europe, Australia and New Zealand.
Read the full press release here