Acrivon Therapeutics announces FDA granted BDD for ACR-368

Acrivon Therapeutics (ACRV) announced the U.S. Food and Drug Administration, FDA, has granted Breakthrough Device designation, BDD, for the ACR-368 OncoSignature assay, a multiplex immunofluorescence assay for the identification of endometrial cancer patients who may benefit from ACR-368 treatment. The designation reflects the 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. Clinical data presented at ESMO 2024 demonstrates statistically significant segregation of patient responders in biomarker-positive versus biomarker-negative subgroups based on prospective OncoSignature patient selection.