Clinical stage precision medicine company Acrivon Therapeutics Inc (Nasdaq:ACRV) announced on Wednesday that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation for its ACR-368 OncoSignature assay.

The assay is designed to identify endometrial cancer patients most likely to benefit from ACR-368 treatment.

Breakthrough Device designation reflects the assay's potential to improve treatment outcomes for life-threatening diseases. Acrivon is currently evaluating ACR-368 in a Phase 2b trial for endometrial cancer and other tumour types.

Clinical data presented at ESMO 2024 demonstrated a statistically significant correlation between biomarker-positive patients and response to ACR-368. The trial reported an overall response rate of 62.5% in biomarker-selected patients.

Developed using Acrivon's Predictive Precision Proteomics platform, the assay enables precise patient selection and drug development. There are approximately 30,000 new cases of advanced or recurrent endometrial cancer annually in the United States.

The Breakthrough Devices Program aims to expedite the regulatory review process, facilitating timely patient access to innovative medical technologies.