SpeeDx

Aiming to receive 501(k) clearance for its M. genitalium detection panel early next year, the firm plans to initially target the assay for use in US hospitals and private pathology centers.

The deal covers SpeeDx's line of multiplexed PlexPCR and ResistancePlus tests in the UK and Ireland.

The ResistancePlus MG Positive Control kit was listed with the FDA for sale in the US, where it will be sold through SpeeDx's US entity.

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.

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