Early May 2023, TAGMe DNA Methylation Detection Kit(qPCR) for Urothelial Cancer independently developed by Shanghai Epiprobe Biotechnology Co., Ltd, obtained “Breakthrough Device Designation” from US FDA.
US FDA Breakthrough Devices Program aims to ensure promoting the approval of manufacturers’ products to market in a relatively short period of time, and enable patients to use advanced products earlier.
To qualify as a Breakthrough Device, two key requirements must be met,
1, Aids in more effective treatment or diagnosis of life-threatening or debilitating diseases or conditions.
2, Meet at least one of the following requirements,
A, Represents a breakthrough technology.
B, No approved alternative product.
C, Compare with existing approved products, it has significant advantages.
D, Usability is in the best interest of the patient.
The designation not only means that Epiprobe’s technological innovation in the early detection of urothelial cancer has been recognized by the authorities, but also confirms the great clinical significance and social value of UCOM (universal cancer only markers) in the detection of urothelial cancer. Urothelial cancer detection kits will also enter the fast track for registration, application and marketing in the United States.
Post time: Jun-09-2023