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Corporate Style | AcornMed · Youai ® Launched with Great Weight and Significance!
On October 29, the early detection kit for urothelial cancer (bladder cancer cancer, ureter cancer, and renal pelvis cancer) independently developed by AcornMed, the combined detection kit for human FGFR3/TERT gene mutation and ONECUT2/VIM gene methylation (PCR fluorescent probe method) - AcornMed · Youai ® Formally obtained the approval of Class III Medical Device Registration Certificate from the National Medical Products Administration (NMPA).
Urethral epithelial cancer is a highly occult, malignant tumor with a high degree of malignancy and a high recurrence rate. Among the commonly used diagnostic methods, ultrasound and urine cytology have low sensitivity and are prone to missed diagnosis. The painful process of endoscopic examination (cystoscopy, ureteroscopy) is unbearable for patients. As the only product recommended by authoritative guidelines such as the 2024 CSCO Guidelines for Diagnosis and Treatment of Urinary Epithelial Cancer, the Expert Consensus for Early Diagnosis and Treatment of bladder cancer (2024 Edition), the Technical Expert Consensus of China Cancer Screening Center, AcornMed Youai ® The listing of this product will create a new diagnosis and treatment model for suspected and high-risk patients with urothelial carcinoma, which is "less money, less suffering, and more accurate", helping clinical decision-making and striving for the best treatment time for patients.
AcornMed Youai ® It is a multicenter, double-blind, prospective registered clinical study initiated by Professor Ye Dingwei's team from Fudan University Cancer Hospital, Professor He Zhisong's team from Peking University First Hospital, and Professor Niu Yuanjie's team from Tianjin Medical University Second Hospital. A total of 1080 clinical patients were enrolled, with an overall sensitivity of 92.5% and specificity of 95.8%. This performance is the most outstanding among the publicly reported data worldwide, and the related research data has been published in the internationally authoritative journal Molecular Cancer (with an impact factor of 41.444, ranking in the top 5% of oncology).
From basic technological innovation to prospective clinical trial verification, AcornMed has taken six years to overcome a series of technical challenges such as urine sample storage, extraction, detection marker development, and model establishment. From tens of thousands of potential biomarkers, it has found four markers, FGFR3, TERT, ONECUT2, and VIM, that are significantly related to the occurrence and development of urothelial carcinoma, in order to create this globally leading urine early detection product. Before obtaining NMPA approval, AcornMed Youai ® It has also obtained breakthrough medical device certification from the US FDA, and early research and development data has been published in the international authoritative journal Molecular Cancer, which fully proves that AcornMed Youai ® Excellent product strength The person in charge of AcornMed stated.
AcornMed is a high-tech enterprise specializing in precision medical detection of tumors. Relying on its strong technological innovation and transformation capabilities, it has developed a series of tumor gene detection products with core intellectual property rights. In 2019, invested in the construction of a production conversion base in Wuqing Development Zone. We have formed three major business layouts: early diagnosis and screening of tumors, precision medical testing for cancer patients, and global research and development cooperation with anti-tumor drug companies. In the future, AcornMed Medicine will always focus on pain points of clinical concern, continuously launch a series of original first-class products, create new diagnostic and treatment models, and benefit the vast number of doctors and patients.
Source：Wuqing Development Area, Tianjin, China
Release Time：2024-10-31 10:18:00
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