Beijing-based tumor precision medicine specialist, AcornMed, has been granted Breakthrough Device Designation (BDD) by the US FDA for its early screening liquid biopsy product, AcornMed utLIFE-UC, designed for detecting urothelial carcinoma.
Innovative Liquid Biopsy Technology for Urothelial Carcinoma Detection
The AcornMed utLIFE-UC product leverages the company’s proprietary database and algorithms to identify specific biomarkers of urothelial carcinoma. It offers a multi-dimensional and multi-omic approach to non-invasively detect early stages of bladder cancer, ureteral cancer, and renal pelvis cancer through urine samples. This innovative method provides a significant advancement in the early detection of these cancers.
Implications of BDD Status for AcornMed utLIFE-UC
The BDD status not only accelerates the development and review process of the AcornMed utLIFE-UC product but also signifies that the product may be covered by the Centers for Medicare & Medicaid Services in the US. This designation is a significant milestone for AcornMed, as it highlights the potential impact of their liquid biopsy product on improving early cancer detection and patient outcomes.-Fineline Info & Tech
