Policy & Regulation
Acrivon Therapeutics secures FDA Breakthrough Device designation for ACR-368 OncoSignature assay
28 November 2023 -

Clinical stage biopharmaceutical company Acrivon Therapeutics Inc (Nasdaq:ACRV) announced on Tuesday that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation for its ACR-368 OncoSignature assay, a multiplex immunofluorescence assay designed to identify ovarian cancer patients who may benefit from ACR-368 treatment.

This designation acknowledges the FDA's belief that the device could enhance the treatment or diagnosis of life-threatening or irreversibly debilitating human diseases.

Based on the Acrivon Predictive Precision Proteomics (AP3) platform, the ACR-368 OncoSignature assay is being used in Acrivon's ongoing Phase 2 trial to predict patient responses to the CHK1/2 inhibitor ACR-368 across three tumour types. The AP3 platform is also used more broadly to uncover resistance mechanisms and rational drug combinations, and for biological rational drug design for Acrivon's drug candidates.

Acrivon has partnered with spatial phenotyping specialist Akoya Biosciences Inc (NASDAQ:AKYA) to co-develop, validate and commercialise the ACR-368 OncoSignature assay.