SpeeDx

The Australian company incorporated the subsidiary as it plans for the US launch of its ResistancePlus MG assay.

The test is designed to detect and differentiate herpes simplex virus types 1 and 2, Treponema pallidum, and varicella-zoster virus.

The agreement will open markets in Denmark, Sweden, and Norway for SpeeDx's STI detection product lines.

The funding will be used to pay for clinical trials in the US that will be used as underlying evidence for FDA clearance of the test, the company said.

The deal covers SpeeDx's PlexPCR and ResistancePlus multiplex real-time PCR diagnostic products in certain European nations.

The companies will work together to secure US approval for SpeeDx's antibiotic-resistant Mycoplasma genitalium assay.

As SpeeDx preps for the European launch of its STI tests, it will incorporate UgenTec's automated data analysis tool for PCR applications.

The firm plans to submit the Mycoplasma genitalium test to the FDA in 2017 and has entered an agreement with the CDC for test evaluation. 

The multiplex qPCR test can detect and discriminate herpes simplex virus 1 and 2 as well as varicella zoster virus, which can be mistaken for HSV in a proportion of cases.

The antibiotic-resistant Mycoplasma genitalium test would be the first on the market for a pathogen with increasing evidence for adverse outcomes.

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