Acrivon Therapeutics Gets FDA's Breakthrough Designation for Cancer Assay

By Dean Seal

Acrivon Therapeutics said federal regulators have granted breakthrough device designation for its ACR-368 OncoSignature assay, which is being developed to identify ovarian cancer patients who may benefit from ACR-368 treatment.

The Watertown, Mass.-based company said the U.S. Food and Drug Administration's designation will help get patients and healthcare providers more timely access to its medical device by speeding up the development, assessment and review processes for premarket approval and marketing authorization.

Chief Executive Peter Blume-Jensen said the assay is being developed to predict tumor sensitivity to ACR-368 and used in ongoing clinical studies.

Breakthrough device designation is granted to devices that may provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions for which no approved alternative exists.

"We believe this designation is the first of its kind for such an assay, and represents yet another powerful validation of our [Acrivon Predictive Precision Proteomics] platform," Blume-Jensen said.

Write to Dean Seal at dean.seal@wsj.com

(END) Dow Jones Newswires

November 28, 2023 08:43 ET (13:43 GMT)

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