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SpeeDx Awarded A$2.5M Grant, Inks Scandinavian Distribution Deal

NEW YORK (GenomeWeb) – Australian molecular diagnostics company SpeeDx said it has received a A$2.5 million ($2 million) grant from the New South Wales Medical Devices Fund (MDF) to support the continued rollout of its multiplex molecular diagnostic ResistancePlus MG test.

Separately, it also announced a distribution deal with Scandinavian clinical laboratory supplier Diagen. 

The Australian funding, announced on Monday, will support US clinical trials, the results of which can be used as underlying evidence in an application to the US Food and Drug Administration for clearance of the test. ResistancePlus MG both detects the infectious sexually transmitted infection Mycoplasma genitalium and identifies markers in the bacterium's 23S rRNA that confer resistance to the macrolide drug azithromycin. SpeeDx also plans to use part of the new grant to develop additional tests for antibiotic resistance.

"The NSW MDF funding allows us the scope to achieve some near-term key milestones with product approval," SpeeDx CEO Colin Denver said in a statement. "Accessing the US market and bringing our pipeline of antibiotic resistance-focused products to regulatory approval are paramount to the overall success of our business."

In April, SpeeDx entered into a strategic partnership with Thermo Fisher Scientific to obtain FDA clearance for ResistancePlus MG. Under the terms of that deal, SpeeDx will submit the test to the FDA after it is successfully validated for use on the Applied Biosystems 7500 Fast Dx Real-Time-PCR system.

The company received CE marking for the diagnostic in September 2016.

Today, SpeeDx announced its deal with Diagen, which it said will open crucial sales channels in Denmark, Sweden, and Norway for SpeeDx's PlexPCR and ResistancePlus real-time PCR product lines.

Using SpeeDx's technology, the PlexPCR range will enable Diagen customers to receive diagnostic information on STIs and other infectious diseases from a single test. The agreement will also provide Diagen customers access to SpeeDx's ResistancePlus MG assay. The assay is the first CE-IVD test to simultaneously detect M. genitalium and genetic markers for azithromycin resistance, as recommended by new European guidelines on M. genitalium resistance screening in the management of  non-gonococcal urethritis.