AcornMed's utLIFE-UC Urinary Tract Cancer Early Screening Test Receives FDA Breakthrough Device Designation

September 9, 2023,Golden Oak MedicineSelf-Developed Liquid Biopsy Product for Early Screening of Urothelial CarcinomaAcornMed^® utLIFE-UC™ Urothelial Carcinoma Assay (utLIFE-UC, marketed in China as U Ai™) has been granted by the U.S. Food and Drug Administration (FDA)"Breakthrough Medical Device" Designation(Breakthrough Device Designation). At the China International Fair for Trade in Services, which concluded last week, utLIFE-UC stood out among numerous candidate demonstration cases due to its leading edge, innovativeness, and public benefit, and was awarded the title of “Demonstration Case for Technological Innovation Services.”

utLIFE-UC leverages Jinxiang Medicine’s proprietary database and algorithms to screen for urothelial carcinoma-specific biomarkers using a multi-dimensional, multi-omics approach, enabling simultaneous non-invasive detection of early-stage bladder cancer, ureteral cancer, and renal pelvic cancer via urine samples.

This time, it received the FDA "Breakthrough Device" designation,This not only signifies that the innovativeness, efficacy, and clinical value of utLIFE-UC in the early detection of urothelial carcinoma have been recognized by international authoritative regulatory agencies., while also greatlyAccelerate the overseas regulatory filing and product launch of utLIFE-UCprocess, and the product will be covered by insurance from the U.S. Centers for Medicare & Medicaid Services (CMS) upon approval, facilitating rapid internationalization and large-scale clinical application.

What is the "Breakthrough Medical Device Program"?

The “Breakthrough Devices Program” is a “fast-track” initiative launched by the FDA in April 2015 to accelerate the development and review of medical devices. It provides patients with life-threatening or irreversible degenerative diseases greater access to treatments, facilitating timely availability of newer, more effective, and safer therapies or diagnostic methods. The program covers reviews conducted under the Pre-Market Approval (PMA), Pre-Market Notification [510(k)], or De Novo classification request frameworks. Given the global leadership of U.S. medical devices, the FDA’s “Breakthrough Devices” designation represents, to some extent, the forefront of global innovation in the medical device industry.

What are the benefits of being included in the FDA’s “Breakthrough Devices Program”?

The FDA will provide “end-to-end support” throughout the entire market lifecycle for products designated as “Breakthrough Devices,” including priority review, timely interactive communication, balanced assessment of pre- and post-market clinical data, flexible and efficient clinical trial designs, and expedited reviews of manufacturing quality systems. The implementation of the “Breakthrough Devices Program” has effectively facilitated the clinical adoption and application of breakthrough products.

“What are the criteria for ‘Breakthrough Medical Device’ certification?”

Medical device products applying for “Breakthrough Medical Device Designation” must simultaneously meet the following two criteria: First, the device is used to treat or diagnose life-threatening diseases. Second, the device must satisfy at least one of the following conditions: a. it represents a breakthrough technology; b. there are no approved alternative products on the market; c. it offers significant advantages over existing or approved alternative products; d. the accessibility of the device aligns with the best interests of patients.