Acrivon Therapeutics Gets FDA Breakthrough Device Designation for Cancer Identification

Dow Jones

Feb 05, 2025

By Chris Wack

Acrivon Therapeutics said the Food and Drug Administration has granted Breakthrough Device designation for its ACR-368 OncoSignature assay, an immunofluorescence assay for the identification of endometrial cancer patients who may benefit from ACR-368 treatment.

The precision medicine company said the new 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.

The company said it sponsored a blind, third-party market research study, which showed strong interest in the emerging clinical profile of ACR-368.

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.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

February 05, 2025 08:20 ET (13:20 GMT)

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