Acrivon Therapeutics, Inc.?s Acrivon Predictive Precision Proteomics or AP3, announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the ACR-368 OncoSignature assay, a multiplex immunofluorescence assay for the identification of ovarian cancer patients who may benefit from ACR-368 treatment. The designation reflects FDA?s determination that the device is reasonably expected to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions. The Breakthrough Devices Program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and marketing authorization.

Acrivon has partnered with Akoya Biosciences to co-develop, validate, and commercialize Acrivon?s ACR-368 OncoSignature assay.