Yuding Bio's Groundbreaking Urine-Based RNA Diagnostic Kit for Prostate Cancer Receives China's First Approval, Unlocking a Billion-Dollar Non-Invasive Screening Market
Recently,York Biotech’s self-developed “Human PCA3 and PSA Gene Expression Detection Kit (Fluorescent PCR Method)” has officially received the Class III Medical Device Registration Certificate from the National Medical Products Administration (NMPA) (Registration No.: Guo Xie Zhu Zhun 20253400447), becoming China’s first RNA-based urine test for the early diagnosis of prostate cancer.
According to the introduction, this product can painlessly and rapidly differentiate prostate cancer patients from those with benign conditions through urine testing, reducing the risk of complications such as infection and pain caused by biopsies, while also alleviating the burden on medical resources.
According to the "Chinese Guidelines for Prostate Cancer Screening and Early Diagnosis and Treatment (2022 Edition)," the survival time of prostate cancer patients is closely related to the stage of malignancy at clinical diagnosis. In China, the majority of newly diagnosed prostate cancer cases are in the intermediate to advanced stages, with only 30% being clinically localized cases. Most patients are already in the intermediate to advanced stages at the time of diagnosis, resulting in less than ideal post-treatment recovery outcomes for prostate cancer patients in China. In contrast, over 80% of newly diagnosed prostate cancer cases in the United States are clinically localized, with a 5-year survival rate approaching 100%. This indicates that strengthening early screening and diagnosis of prostate cancer and improving the detection rate of early-stage cases are key to enhancing patient prognosis in China.
The approval of China’s first RNA-based urine test for early diagnosis of prostate cancer provides a novel solution for early screening and precision diagnosis and treatment of prostate cancer. The promotion of this innovative product is expected to further increase the early diagnosis rate of prostate cancer in China, thereby improving patient survival rates and quality of life.
Currently, the early diagnosis of prostate cancer is facing a severe dilemma—a trade-off between invasiveness and patient compliance, as well as a significant disconnect between diagnostic efficacy and clinical needs.
Serum Prostate-Specific Antigen (PSA) testing, a commonly used clinical screening tool, has long faced the urgent challenge of an excessively high false-positive rate. As PSA is not a specific marker, it is susceptible to interference from various non-specific factors such as inflammation and benign prostatic hyperplasia, resulting in a false-positive rate as high as 70%.1, which means that a large number of patients are forced to undergo needle biopsy due to "suspiciously elevated" PSA levels. However, as an invasive procedure, needle biopsy not only poses risks of complications such as bleeding and infection to patients, but the incidence rate can reach 10%.2, meanwhile, the missed diagnosis rate of traditional biopsy for clinically significant prostate cancer remains as high as 15%–20%.3This means that under the current diagnostic paradigm, many patients not only endure unnecessary pain from biopsies but may also miss the optimal window for treatment due to missed diagnoses. Meanwhile, the prostate cancer screening rate among men aged 50 and older in China is less than 18%. This low screening rate directly results in nearly 60% of patients being diagnosed at a metastatic stage, thereby losing the opportunity for early intervention.
Faced with this predicament,Leveraging its world-class R&D team and technological expertise, York Biotech has launched the revolutionary “Human PCA3 and PSA Gene Expression Detection Kit (Fluorescent PCR Method),” which not only offers new possibilities for the early diagnosis of prostate cancer but also represents a significant step forward in non-invasive, precise urine-based diagnostics.
According to Dr. Huang Jiaoti, a titan in the field of urological pathology worldwide, Tenured Professor and Chair of the Department of Pathology at Duke University, and Founder of York BiotechGrantIntroduction: The “Human PCA3 and PSA Gene Expression Detection Kit (Fluorescent PCR Method),” which has obtained the first domestic regulatory approval in China, employs non-invasive urine sampling. It utilizes real-time quantitative PCR technology to quantitatively detect mRNA expression levels. Based on the final calculations, it assesses the risk of prostate cancer occurrence, significantly improving the detection rate of early-stage prostate cancer. Clinical trials have shown thatThe product’s performance metrics are internationally leading, filling the domestic gap in non-invasive, precise diagnostic technologies for urological tumors and addressing the lack of domestic products for early diagnosis of prostate cancer.
It must be emphasized that this product from York Biotech,It effectively eliminates confounding factors such as prostate volume and inflammation, significantly improving the detection rate of prostate cancer and providing a novel solution for early screening and precision diagnosis and treatment in patients with prostate cancer.Professor Huang Jiaoti pointed out: “As a novel prostate cancer-specific genetic biomarker, PCA3 demonstrates significantly superior sensitivity and specificity compared to traditional PSA testing; however, its clinical translation faces challenges such as urine sample stability, nucleic acid enrichment efficiency, and assay standardization.”“The team spent seven years overcoming technical challenges, innovating methodologies, and completing clinical validation in nearly 10,000 cases, ultimately achieving a breakthrough.”
Currently, the market for early diagnosis of prostate cancer is ushering in unprecedented development opportunities. According to forecasts by Gongyan Industry Consulting, the market size for prostate cancer drugs will exceed RMB 50 billion by 2030, further confirming that this field has become a blue-ocean market valued at tens of billions, with demand for precision medicine accelerating rapidly.
Top-level design at the national strategic level is accelerating the standardization and scaled development of the early diagnosis market for prostate cancer. The "Healthy China 2030" Planning Outline explicitly sets the goal of “increasing the overall five-year survival rate for cancer by 15% by 2030,” with early cancer screening designated as a key initiative. Furthermore, the "Guidelines for the Diagnosis and Treatment of Prostate Cancer," issued by the National Health Commission in 2024, mandate the prioritization of molecular diagnostic techniques for precise triage among individuals with PSA levels in the gray zone.
From the demand side, prostate cancer has become the second most common cancer among men globally, with both high incidence and mortality rates in China. According to statistics from the National Cancer Center, there were approximately 134,000 new cases and 47,500 deaths from prostate cancer in China in 2022. Meanwhile, the five-year survival rate for prostate cancer in China is only 66.4%, whereas it exceeds 95% in developed countries in Europe and America. The fundamental reason for this disparity lies in the widespread adoption of early diagnosis and screening in Western countries; currently, the penetration rate of prostate cancer screening in China is less than 20%, indicating substantial room for market growth.4. As population aging accelerates and public health awareness becomes widespread, there is an explosive growth in demand for disease prevention and precision diagnosis and treatment, along with a rapid increase in the need for precise, non-invasive testing.
Continuous technological advancements have provided solid and robust support for market development. Currently, precision diagnosis and treatment have become the core driving force in the healthcare sector, spearheading the emergence of a series of more innovative and refined diagnostic methods. The maturity curve of liquid biopsy technology has entered an explosive growth phase, positioning it as a powerful complement to existing PSA testing. Its non-invasive nature, convenience, and repeatability make it a strong alternative to traditional biopsies, holding significant value particularly in early cancer screening and personalized medicine.
The early diagnosis market for prostate cancer is at the convergence of a “golden triangle” comprising policy, demand, and technology. With the advancement of the “Healthy China 2030” strategy and breakthroughs in diagnostic technologies, York Biotech has met the clinical need for precise, non-invasive testing through its innovative “non-invasive urine-based + precision” products, providing significant impetus to the progress of urologic oncology diagnostics in China. Driven by both policy incentives and technological iteration, this field is poised for a historic leap from technological breakthroughs to industrial explosion, offering critical support for achieving the goals of “Healthy China.”
“Currently, the company’s commercialization strategy is well-defined. The products developed by the company are designed to address clinical pain points and meet urgent current clinical needs, thereby helping physicians enhance the current standard of diagnosis and treatment, which in turn enables large-scale clinical adoption.”Zhu Xiaoxia, CEO of York Biotechstated, “Based on our profound understanding of the disease, the early cancer diagnosis industry is a duet of prevention and monitoring. We will stratify populations according to disease progression and develop products for corresponding indications through this stratification process.”
As a technological leader in the field of early cancer diagnosis, York Biotech has implemented a comprehensive strategic layout centered on “liquid biopsy-based approaches with a focus on urological tumors” since its establishment in 2017, driving the research, development, and commercialization of innovative diagnostic products.
Driven by the dual forces of technological innovation and clinical demand, York Biotech is reshaping the landscape of the early prostate cancer diagnosis market through continuous technological advancements and in-depth commercialization strategies, thereby further enhancing its products' competitiveness. Looking ahead, York Biotech will deeply integrate policy incentives, market demand, and technological innovation to consolidate its advantages in early screening for urological tumors and gradually expand into other high-incidence cancer fields. This strategy aims to help more patients seize the optimal window for treatment, benefiting tens of millions of patients and contributing core strength toward achieving the grand vision of "Healthy China 2030."
References:
1. Expert Consensus on Early Diagnosis of Prostate Cancer in China (2021)
2. Chinese Journal of Urology (2020)/PPA (2022)
3. Ahmed HU, et al. "Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS)"(Lancet, 2017)
4. “Global Market Research Report on Prostate Cancer Diagnosis and Treatment” (2024)