Urothelial carcinoma (UC) is one of the most common malignancies of the genitourinary system, which can occur in any part of the urothelium covering the urethelium, including the renal pelvis, ureter, bladder, urethra, etc., with high incidence, difficulty in early diagnosis, and high postoperative recurrence rate.
Urothelial carcinoma (UC) is divided into upper urinary tract urethelial carcinoma (UTUC) and bladder urothelial carcinoma (BUC). Among them, UTUC accounts for 5%-10% of all urothelial carcinomas, and BUC accounts for 90%-95%.
The data shows that there are about 570,000 new cases of BUCs and about 210,000 deaths worldwide. In China, the number of new cases of BUC exceeded 80,000, accounting for 14.9% of the world, the number of deaths was about 39,000, accounting for 18.5% of the world, and the new and dead cases accounted for the first in the world.
Although UTUC accounts for a small proportion of urinary intestinal carcinoma, it is more invasive and worse, with 60% of cases initially diagnosed as invasive (i.e., more harmful). In China, the proportion of UTUC is higher, reaching 9.3% to 29.9%. Therefore, the overall invasiveness of UTUC patients in China is stronger, and the proportion of patients with advanced tumors is higher.
In addition, the occurrence of urinary urothelial carcinoma is highly insidious, often with painless hematuria as a precondition, and it is difficult to make an effective differential diagnosis with stones, inflammation and other diseases in the early stage. For patients with suspected urinary urothelial cancer of unknown cause, diagnosis and postoperative follow-up require cystoscopy, which is very painful, resulting in poor patient compliance and may delay the optimal time for disease treatment.
In view of these clinical pain points, Beijing Oaks Biotechnology Co., Ltd. (hereinafter referred to as "Golden Oak Medicine") launched a series of urine-based urothelial cancer management products in the world - "U Love" series, which further improved the diagnostic methods of urinary intestinal carcinoma, realized the early diagnosis and early screening, medication guidance and efficacy prediction of UC with "one tube of urine", and realized the whole process management from tumor prevention and treatment to accurate diagnosis and treatment.
On April 23, Golden Oak Medical U Love series products were officially released, and invited more than 30 urology experts from all over the country, including Professor Ye Dingwei of Fudan University Affiliated Cancer Hospital, Professor Niu Yuanjie of the Second Hospital of Tianjin Medical University, Professor Wei Qiang of West China Hospital of Sichuan University, Professor He Zhisong of peking University First Hospital, Professor Yao Xin of Cancer Hospital of Tianjin Medical University, and Professor Xue Wei of Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine to witness the listing of Golden Oak Medical U Love series products. At the same time, the patient population and application prospects of urine detection products are discussed in depth.
The presidium attending the meeting said that golden oak medicine's U love series products use urine as a sample source, break multiple technical bottlenecks, use multi-omics technology, multi-dimensional detection of mutation information in urine, can accurately and non-invasively solve the problems to be solved clinically, and its performance parameters are excellent. It is also believed that with the continuous deepening of clinical research on U Love series products, it will be able to better serve patients with urothelial cancer in the future, help clinical decision-making, and achieve accurate diagnosis and treatment of patients with urothelial cancer in the whole process of management. It is hoped that Golden Oak Medicine will develop more detection products that assist in the diagnosis and treatment of urinary tumors in the future, serving the clinic.
"One tube of urine" achieves urothelial cancer
Accurate diagnosis and treatment of the whole process of management
Dr. Cao Shanbai, CEO of Golden Oak Medicine, believes that the significance of technology lies in the ability to truly solve clinical problems, and clinical problems need to be combined with clinical sample data of specific cancers. Technology, samples, clinical outcomes, only by meeting these three can we propose truly valuable solutions for the clinic.
With many years of deep cultivation in the field of urinary system tumors, Golden Oak Medicine has accumulated clinical sample data of nearly 100,000 people. On this basis, it has successively overcome a series of key technologies such as the extraction, enrichment and analysis of urine DNA, and has taken the lead in developing the UAi series of products based on the whole process management of urinary tract carcinoma based on urine.
U love series has three types of products: U love SEEK, U love MRD, and U love HOPE.
First of all, U Love SEEK provides early diagnosis of urothelial cancer for patients with unexplained hematuria.
Secondly, for patients with neoadjuvant therapy, Uai MRD can be used to predict the efficacy of neoadjuvant therapy for urinary urothelial cancer and determine the best time for surgery in time; for patients who need postoperative efficacy monitoring, UAI MRD provides accurate monitoring of postoperative efficacy and monitors postoperative recurrence.
Finally, UAiHOPE can conduct urine panorama targeting and immunotherapy efficacy evaluation, providing patients with precise medication guidance.
Taking urine as a test sample, UAi series products realize the whole process of management of urinary tract carcinoma in three dimensions, from early diagnosis and early screening of tumors, to neoadjuvant efficacy prediction and recurrence monitoring, to precise medication.
As a means of preoperative auxiliary diagnosis of urothelial carcinoma and an auxiliary means of postoperative recurrence monitoring, UAi series products will provide strong help for the clinical diagnosis of urological surgeons; effectively reduce the frequency of cystoscopy in patients with unknown hematuria and re-examination, avoid the pain and inconvenience caused by cystoscopy; promote the early diagnosis and early screening and early treatment of suspected urinary urothelial cancer patients, and move the cancer treatment threshold forward, benefiting 20 million to 50 million hematuria patients in China.
Replace blood with urine,
What technical hurdles need to be overcome?
Since its discovery 70 years ago, liquid biopsy has emerged in the early diagnosis and early screening of cancer, medication guidance, and efficacy prediction through the combined use of a variety of markers, and has begun to affect the whole process of cancer management. Common fluid biopsy samples include blood, cerebrospinal fluid, saliva, urine, and other fluid sample types.
Among these options, urine, as a completely noninvasive biological sample type, stands out for its easy collection, large collection volume, and complete painless collection process, and has been widely used in a variety of urinary system diseases.
Liquid biopsies in the urine are becoming one of the centers of concern for the molecular diagnostics industry. In recent years, there have been literature reports of the use of urine sources for genomic, transcriptome, epigenomics and metagenomics studies, especially for urinary tract tumors, which can exceed blood tests.
The use of urine instead of blood as a test sample has its unique advantages. In the process of implementation, it is inevitable to encounter technical difficulties. Compared with peripheral blood samples, the free DNA fragmentation of urine cells is more serious, the length of fragments is shorter, the amount of DNase in the urine is abundant, and the PH value is unstable, which brings no small interference and challenge to the extraction of free DNA from urine cells.
Secondly, during the transportation and preservation of urine samples, microbial proliferation, cell lysis, and degradation of small fragments may occur, and many of the above factors will change the concentration of real urine tumor DNA in the urine, affecting the detection ratio of target markers, most of the existing solutions that have been reported are complex to operate, costly, and the preservation effect of the sample has decreased seriously with time.
In addition, unlike blood, the use of urine as a clinical sample also requires consideration of the interference caused by inflammation. Not only may it affect the design of clinical protocols, but there are also many problems that need to be solved in terms of the integration of test results and communication with doctors.
In view of the unique characteristics of urine samples, Golden Oak Medicine has done a lot of assessment tests in key aspects such as urine collection mode, storage and transportation mode and extraction and processing mode of urine trace samples, and developed a unique pretreatment and extraction patent technology for urine samples to retain trace signals from tumor cells to the greatest extent.
Combined with the unique signaling pattern of urine cfDNA, the Golden Oak research and development team also developed an exclusive algorithm "utLIFE" based on machine learning methods. Thus realizing the early diagnosis and early screening, medication guidance and efficacy prediction of urinary tract carcinoma can be carried out with "one tube of urine".
To drive technology upgrades with clinical needs,
Contribute to the development of the precision medicine industry
Founded in 2018, Oaks Bio is a leading high-tech enterprise of precision medicine oncology in the industry. With genetic big data and artificial intelligence algorithms as the core, it has completed the precision medicine industry layout integrating "early diagnosis and early screening of tumors, clinical testing, medical device manufacturing and innovative pharmaceutical enterprise services".
The company has built an independent intellectual property system with nearly 100 authorized invention patents and software copyrights as the core, covering the whole process from tumor prevention and treatment to accurate diagnosis and treatment. It has reached strategic cooperation with several well-known enterprises such as HUAWEI CLOUD, BGI Intelligent Manufacturing, Twist Bioscience, AstraZeneca, and Roche Diagnostics to build a sustainable cancer precision medicine ecosystem.
In the past four years or so, Golden Oak Medical has taken the lead in realizing the dual layout of solid tumors and hematological tumors in the industry, and has launched more than 40 kinds of testing products in the "Oak" series and "U Love" series, of which nearly 20 products have obtained Beijing new technology and new product certification and EU CE certification.
For Golden Oak Medicine, what is important is how to develop products that have real medical value and market value. "The UAi series is a very important representative product, which means that we have broken through the original companion diagnosis and begun to truly solve the clinical needs." Dr. Cao Shanbai said.
At present, there are 20 million to 50 million hematuria patients in China, and the number of patients with urinary urothelial cancer is also rising. Dr. Cao Shanbai hopes that in the future, U Love can be included in the daily physical examination screening program. "To achieve this goal, combined with national conditions, it may be necessary to make the product cheaper." We strive to achieve a larger number of people within 2 to 3 years by controlling costs and reducing prices. ”
Based on the future, in the short term, Golden Oak Medicine will combine the past accumulation in the field of hematological tumors, lymphoma, prostate cancer and urinary intestinal carcinoma, and gradually expand to early diagnosis and early screening and MRD. In the long term, the company will work to find more molecular markers that address a wide variety of clinical issues.
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