OpGen files De Novo FDA request for Unyvero UTI panel; sensitivity 96.8%

CapForce Inc.

Submitted De Novo classification request to FDA for Unyvero UTI panel after clinical trial.
Primary endpoint met: weighted avg sensitivity 96.8%, specificity 97.4% across 1,800+ samples.
Panel detects bacterial/fungal pathogens and antimicrobial resistance markers from urine.
OpGen will present study data at ASM Microbe 2023 on June 17.
Unyvero UTI aims to be first high multiplex molecular diagnostic IVD for urine cleared by FDA.

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