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# Breakthrough Status for ACR-368 OncoSignature Assay
- URL: https://www.fdaweb.com/breakthrough-status-for-acr-368-oncosignature-assay/
- Published: 2025-02-05T12:00:00.000Z
- Updated: 2026-09-14T14:52:28.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158608

FDA has granted Acrivon Therapeutics a breakthrough device designation for the ACR-368 OncoSignature assay, which the company describes as a multiplex immunofluorescence assay for identifying endometrial cancer patients who may benefit from ACR-368 treatment. The device is being developed to prospectively predict tumor sensitivity to ACR-368, described by Acrivon as a potent, selective CHK1/2 inhibitor being studied as monotherapy or in combination with low-dose gemcitabine in patients with platinum-resistant ovarian carcinoma, endometrial adenocarcinoma, and urothelial carcinoma. The device was developed using the company’s generative AI-driven Acrivon Predictive Precision Proteomics platform