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)
Copyright (c) 2025 Dow Jones & Company, Inc.
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