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Medical Devices / Submissions and Approvals

SpeeDx Gains CE Mark for Gonorrhea Test

Dec. 7, 2018
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SpeeDx’s ResistancePlus GC gonorrhea assay has earned the CE Mark.

The polymerase chain reaction test detects gonorrhea and allows doctors to assess the disease’s susceptibility to the antibiotic ciprofloxacin before prescribing.

The assay is the first commercially available molecular test in the EU that provides information on the disease’s antibiotic susceptibility.

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