GeneOaks Medicine Breaks Through Key Technical Barriers with 'One-Tube Urine' Solution for Comprehensive Urothelial Carcinoma Management

Urothelial Carcinoma (UC)It is one of the most common malignant tumors of the genitourinary system and can occur in any site lined with urothelium, including the renal pelvis, ureter, bladder, and urethra.High incidence, difficult early diagnosis, and high postoperative recurrence rateand other characteristics.

Urothelial carcinoma (UC) is classified into upper tract urothelial carcinoma (UTUC) and bladder urothelial carcinoma (BUC). Among these, UTUC accounts for 5%–10% of all urothelial carcinomas, while BUC accounts for 90%–95%.

Data show that there are approximately 570,000 new cases of bladder urothelial carcinoma (BUC) and about 210,000 deaths worldwide. In China, the number of new BUC cases exceeds 80,000, accounting for 14.9% of the global total, while deaths reach approximately 39,000, representing 18.5% of the global total. China ranks first globally in both new cases and deaths from BUC.

Although upper tract urothelial carcinoma (UTUC) accounts for a small proportion of urothelial carcinomas, it is more aggressive and has a higher grade of malignancy, with 60% of cases being invasive at initial diagnosis. In China, the proportion of UTUC is higher, ranging from 9.3% to 29.9%. Therefore, Chinese UTUC patients overall exhibit greater aggressiveness, and there is a higher proportion of patients with advanced-stage tumors.

Furthermore,Urothelial carcinoma has a highly insidious onset, often presenting with painless hematuria as an initial symptom., making it difficult to effectively differentiate from conditions such as calculi and inflammation in the early stages. For patients with suspected urothelial carcinoma of unknown etiology, diagnosis and postoperative follow-up require cystoscopy, a highly painful procedure that leads to poor patient compliance and may delay optimal treatment timing.

To address these clinical pain points, Beijing Xiangxin Biotechnology Co., Ltd. (hereinafter referred to as “Jinxiang Medicine”) hasGlobal Debut of the “U-Ai” Series: A Comprehensive Urine-Based Product Line for the Full-Course Management of Urothelial Carcinoma, further improving the diagnostic methods for urothelial carcinoma, achieving“A single urine sample” enables early detection and screening of urothelial carcinoma, guides medication, and predicts treatment efficacy, achieving comprehensive management from tumor prevention and control to precision diagnosis and therapy.。

On April 23, Jinxiang Medicine officially launched its U-Ai series products. The event was attended by more than 30 urology experts from across China, including Professor Ye Dingwei from Fudan University Shanghai Cancer Center, Professor Niu Yuanjie from the Second Hospital of Tianjin Medical University, Professor Wei Qiang from West China Hospital of Sichuan University, Professor He Zhisong from Peking University First Hospital, Professor Yao Xin from Tianjin Medical University Cancer Institute and Hospital, and Professor Xue Wei from Renji Hospital, Shanghai Jiao Tong University School of Medicine. These experts jointly witnessed the market debut of the U-Ai series and engaged in in-depth discussions on the target patient populations for urine testing products and their application prospects.

The presiding chairman stated in his address that Golden Acorn Medical’s U-Ai series leverages urine as a sample source, overcoming multiple technical bottlenecks. By employing multi-omics technologies, it performs multidimensional detection of variant information in urine, offering precise and non-invasive solutions to unresolved clinical challenges with excellent performance parameters. It is believed that as clinical research on the U-Ai series deepens, it will better serve patients with urothelial carcinoma in the future, aiding clinical decision-making and enabling comprehensive, precision-based management throughout the entire diagnostic and therapeutic journey. It is hoped that Golden Acorn Medical will continue to develop more diagnostic products to assist in the diagnosis and treatment of urological tumors, thereby better serving clinical practice.

Dr. Cao Shanbai, CEO of Jinxiang MedicineConsider, the significance of technology lies in its ability to truly address clinical problems, which need to be examined in conjunction with clinical sample data specific to particular cancer types.Technology, Samples, and Clinical Outcomes: Only by satisfying all three can truly valuable solutions be proposed for clinical practice.

With years of in-depth expertise in urological oncology, Golden Acorn Medical has accumulated clinical sample data from nearly 100,000 individuals. Building on this foundation, the company has successively overcome a series of key technical challenges, including urinary DNA extraction, enrichment, and analysis, and has pioneered the breakthrough development of the “U-Ai” product series for the comprehensive management of urothelial carcinoma based on urine testing.

The U Love series includes a total of UThree Product Categories: iSEEK, uMRD, and uHOPE。

First, U-Ai SEEK provides early diagnosis of urothelial carcinoma for patients with unexplained hematuria.

Secondly, for patients undergoing neoadjuvant therapy, U-Ai MRD can predict the efficacy of neoadjuvant therapy for urothelial carcinoma and help determine the optimal timing for surgery; for patients requiring postoperative efficacy monitoring, U-Ai MRD provides precise postoperative monitoring to detect recurrence.

Finally, U-Ai HOPE can perform panoramic urine-based targeted therapy and immunotherapy efficacy assessments, providing patients with precise medication guidance.

U-Ai Series Products Using Urine as the Test SampleFrom early diagnosis and screening of tumors, to prediction of neoadjuvant therapy efficacy and recurrence monitoring, and finally to precision medication, achieving full-process management of urothelial carcinoma across three dimensions.

As a tool for preoperative auxiliary diagnosis of urothelial carcinoma and postoperative recurrence monitoring, the U-Ai series products will provide strong support for clinical diagnosis by urologists; effectively reduce the frequency of cystoscopy in patients with unexplained hematuria and those undergoing follow-up examinations, thereby avoiding the pain and inconvenience associated with cystoscopy; promote early detection, screening, and treatment of suspected urothelial carcinoma cases, shifting cancer treatment to an earlier stage, and benefiting 20–50 million hematuria patients in China.

Since its discovery 70 years ago, liquid biopsy has emerged as a promising tool in early cancer detection and screening, treatment guidance, and efficacy prediction through the combined use of multiple biomarkers, and it has begun to influence the comprehensive management of cancer. Common liquid biopsy samples include blood, cerebrospinal fluid, saliva, urine, and other bodily fluids.

Among these options, urine, as a completely non-invasive biological sample type, stands out for its ease of collection, large sample volume, and entirely painless collection process, and has already been widely applied in various urological diseases.

Urine liquid biopsy is emerging as one of the focal points in the molecular diagnostics industry.In recent years, there have been successive reports in the literature on utilizing urine-derived samples for genomic, transcriptomic, epigenomic, and metagenomic studies.Especially for tumors of the urinary system,Performance can surpass blood tests。

Using urine instead of blood as a testing sample offers unique advantages. However, technical challenges are inevitably encountered during implementation. Compared with peripheral blood samples, cell-free DNA (cfDNA) in urine exhibits more severe fragmentation and shorter fragment lengths. Additionally, the abundant presence of DNases and unstable pH levels in urine pose significant interference and challenges to the extraction of urinary cell-free DNA.

Secondly, during transportation and storage, urine samples may undergo microbial proliferation, cell lysis, and degradation of small fragments. These factors can alter the true concentration of urinary tumor DNA, thereby affecting the detection rate of target biomarkers. Most existing solutions reported to date are complex to operate and costly, with sample preservation efficacy declining significantly over time.

Furthermore, unlike blood, using urine as a clinical sample requires consideration of interference caused by inflammation. This not only potentially affects the design of clinical protocols but also presents numerous challenges in integrating test results and communicating with physicians.

Golden Oak Medicine, targeting the unique characteristics of urine samples,Extensive evaluation and testing have been conducted on critical steps, including urine collection, storage and transportation, as well as the extraction and processing of trace urine samples. Proprietary patented technologies for the pretreatment and extraction of urine samples have been developed., to maximally preserve the minute signals derived from tumor cells.

By integrating the unique signal patterns of urinary cell-free DNA (cfDNA), the Golden Oak R&D team has also developed a proprietary algorithm, “utLIFE,” based on machine learning. This enables early detection and screening of urothelial carcinoma, guidance for medication, and prediction of therapeutic efficacy using just “a single urine sample.”

Founded in 2018, Xiangxin Biotechnology is a leading high-tech enterprise in the field of precision oncology. Leveraging core capabilities in genomic big data and artificial intelligence algorithms, the company has established a comprehensive precision medicine ecosystem integrating “early cancer diagnosis and screening, clinical testing, medical device manufacturing, and services for innovative pharmaceutical companies.”

The company has established an independent intellectual property system centered on nearly 100 authorized invention patents and software copyrights, covering the entire process from tumor prevention and control to precision diagnosis and treatment. It has successively entered into strategic collaborations with several renowned enterprises, including Huawei Cloud, MGI Tech, Twist Bioscience, AstraZeneca, and Roche Diagnostics, to jointly build a sustainable ecosystem for precision oncology.

Jinxiang Medicine is the clinical testing service brand under Xiangxin Biotechnology. Over the past four years, it has taken the lead in the industry by establishing a dual presence in both solid tumors and hematologic malignancies. It has successively launched more than 40 testing products in its “Xiang” series and “U Ai” series, among which nearly 20 have obtained Beijing New Technology and New Product Certification and EU CE marking.

For Jinxiang Medicine, the key lies in developing products that possess genuine medical and market value. “The U-Ai series represents a pivotal flagship product, signifying our breakthrough beyond traditional companion diagnostics to truly address critical unmet clinical needs,” said Dr. Cao Shanbai.

Currently, there are 20 to 50 million patients with hematuria in China, and the number of urothelial carcinoma cases is also on the rise. Dr. Cao Shanbai hopes that U-Ai can be included in routine health check-up screening programs in the future. “To achieve this goal, and considering national conditions, the product may need to be more affordable. We aim to reduce costs and lower prices within two to three years, thereby enabling its use by a larger population.”

Looking to the future, in the short term, Golden Oak Medicine will leverage its accumulated expertise in hematologic malignancies, lymphoma, prostate cancer, and urothelial carcinoma to gradually expand into early diagnosis, early screening, and minimal residual disease (MRD) detection. In the long run, the company is committed to identifying additional molecular biomarkers to address a wide range of clinical challenges.