Funding will support US clinical trials, FDA clearance of ResistancePlus™ MG test and development of further tests for antibiotic resistance
, AUSTRALIA - Sep 18, 2017 - SYDNEY, AUSTRALIA - (September 18, 2017). For a second time, SpeeDx Pty. Ltd., an Australian-based molecular diagnostics company, was awarded a grant from the New South Wales Medical Devices Fund (MDF). SpeeDx was awarded AU $2.5 million for the 2017-2018 funding period to support the continued roll-out of its one-of-a-kind multiplex molecular diagnostic tests that detect infectious diseases and identify antibiotic resistant strains of the disease.
The NSW MDF funding allows us the scope to achieve some near-term key milestones with product approval, said Colin Denver, CEO. Accessing the U.S. market and bringing our pipeline of antibiotic resistance focused products to regulatory approval are paramount to the overall success of our business.
SpeeDx products focus on sexually transmitted infections (STIs) and other infectious disease panels using proprietary technology that yields treatment-specific information for antibiotic resistant infections to be obtained from a single, cost-effective test. In 2016, SpeeDx launched
ResistancePlus
® MG, the first commercially available test combining detection for the increasingly treatment-resistant STI
Mycoplasma genitalium
with identification of genetic markers responsible for antibiotic resistance.
Since winning the first grant in 2014, SpeeDx have doubled in size, opened a new production facility, and successfully achieved sales of their market-leading
ResistancePlus
® MG test in 6 countries worldwide. SpeeDx has recently entered into a strategic partnership with ThermoFisher Scientific in the US for clearance of its ResistancePlus® MG test and a European distribution partnership for the test with Cepheid. The 2017 funds will support continued growth of the Sydney-based design and manufacturing facilities, along with increased global sales, including bringing
ResistancePlus
® MG to the US market.
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.plexpcr.com