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SpeeDx and Thermo Fisher Scientific announce strategic partnership for FDA clearance of molecular diagnostic test

publication date: May 31, 2017
 | 
author/source: SpeeDx

ResistancePlus™ MG Test would bring disease and antibiotic resistance testing for potential “superbug”

SpeeDx logoSpeeDx Pty. Ltd., a developer of innovative molecular diagnostic solutions, has signed an agreement with Thermo Fisher Scientific, the world leader in serving science. The announcement was made at the 27thEuropean 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.”


Find out more about ResistancePlus™ MG Test


About SpeeDx

Founded in 2009, SpeeDx is an Australian-based private company with offices in London and distributors across Europe. SpeeDx specializes in molecular diagnostic solutions that go beyond simple detection to offer comprehensive information for improved patient management. Innovative real-time polymerase chain reaction (qPCR) technology has driven market-leading multiplex detection and priming strategies. Product portfolios focus on multiplex diagnostics for sexually transmitted infection (STI), antibiotic resistance markers, and respiratory disease. Currently, SpeeDx markets the only CE-marked and TGA approved commercial molecular test for the STI M. genitalium (ResistancePlus™ MG) that combines detection of the disease with detection of markers for antibiotic resistance.

For more information on about SpeeDx please see: http://www.speedx.com.au


About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of $18 billion and more than 55,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.

For more information, please visit www.thermofisher.com


 


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