KR Pharmtech Wins 'Most Valuable Investment Award' and Expands Molecular Diagnostics for Intracranial Tumors
In late March, the “Bright·Lab – The 4th IVD Young Entrepreneurs Forum,” hosted by the Medical Laboratory Industry Branch of the China Association for Health Industry Enterprise Management (CAIVD), concluded successfully at the Chongqing Yuelai International Convention Center. Guests from research institutions, healthcare facilities, and the industry gathered around the forum theme “Vision · Strategy · Opportunity” to discuss hot topics such as innovation in chronic disease management, the clustered development and global expansion of the IVD industry, and the clinical application of innovative IVD technologies.
During the subsequent roadshow session for youth entrepreneurship and innovation projects, Kuoran Biomedical Technology (Shanghai) Co., Ltd. (hereinafter referred to as “Kuoran Genomics”) was awarded the Investment Value Award.
Having cultivated expertise in molecular oncology diagnostics for six years, the company has quietly established a distinctive advantage in the molecular diagnosis of intracranial tumors. It offers a comprehensive suite of molecular diagnostic services covering gliomas, meningiomas, ependymomas, medulloblastomas, and other intracranial neoplasms. By 2020, its business scale had risen to second place in the industry. Its independently developed Capitol-X and Capitol-M series, along with proprietary algorithms, hold an irreplaceable competitive edge in the field.
In the view of Mr. Bu Lingbin, Chairman of Kuoran Genomics, in addition to optimizing and enhancing its testing technology platforms, the company’s precise understanding of and rapid response to genuine clinical needs were key factors that enabled it to stand out during this roadshow. “Taking our glioma diagnosis project as an example, we closely monitor the most urgent emerging demands driven by iterations in clinical diagnostic and therapeutic technologies,” Mr. Bu told VCBeat. “By maintaining continuous tracking from preoperative through intraoperative to postoperative stages, we effectively improve molecular diagnostic efficiency and elevate the standard of care for glioma, ultimately benefiting patients.”
At this roadshow, Mr. Zhang Rui, co-founder of Kuoran Genomics, primarily showcased the innovative clinical applications of Kuoran Genomics’ flagship project: molecular diagnosis of glioma.
Gliomas are the most common intracranial tumors in clinical practice. They are associated with poor prognosis, high recurrence rates, and reduced quality of life. In China, the annual incidence of gliomas is 6.2 per 100,000 population. Based on the number of glioma surgeries served, Kuoran Genetics holds a market share of approximately 60% in this niche segment.
Unlike malignant tumors arising in other organs, conventional pathological diagnosis cannot objectively reflect the true biological characteristics of gliomas; therefore, molecular diagnosis is an indispensable component in establishing the pathological diagnosis of brain gliomas.
The 2018 edition of the “Chinese Guidelines for Diagnosis and Treatment of Glioma” explicitly states that gliomas require testing for molecular markers such as IDH, 1p/19q, EGFR, TERTp, and BRAF. In other words, with advances in genomics and molecular biology, the diagnosis of glioma has entered an era of “no molecular profiling, no diagnosis.”
Gliomas also present challenges in tissue sampling; for instance, limitations of biopsy techniques, tumor heterogeneity, sampling location, and sample size can all affect the accuracy of pathological diagnosis. Furthermore, it is difficult to obtain pathological tissue via surgery or needle biopsy in many patients with lesions located in inaccessible or high-risk areas.
Furthermore, there are currently limited multimodal treatment options for glioma, with surgery remaining the most effective therapeutic approach. Given the unique characteristics of brain tissue and its functional implications, glioma resection is highly complex. Optimizing surgical strategies based on molecular features has been widely adopted in clinical practice as the most effective means to improve patient prognosis.
According to Mr. Zhang Rui, Kuoran Genomics has laid out its molecular diagnostic products around the perioperative period, covering preoperative, intraoperative, and postoperative stages.
In recent years, the use of ctDNA technology to detect nucleic acid fragments released by tumor cells in the blood has been proven applicable for molecular diagnosis of tumors, monitoring treatment efficacy, and predicting prognosis. However, due to the presence of the blood-brain barrier, cfDNA released by brain tumors is difficult to detect in peripheral blood. Cerebrospinal fluid (CSF), the body’s own circulating fluid within the brain, fills the ventricles and spinal canal and comes into direct contact with tumor cells at the lesion site, allowing for the detection of molecular biomarkers of brain tumors in the CSF.
However, the concentration of cell-free DNA (cfDNA) in cerebrospinal fluid (CSF) is relatively low, and the sensitivity of qPCR and NGS fails to meet detection requirements. For instance, with an NGS sensitivity of only 1%, false-negative results are highly likely. There is a clinical gap in glioma diagnosis and treatment for detection methods that offer high sensitivity, low equipment requirements, and rapid turnaround. To address this, Kuoran Gene leverages its proprietary digital PCR technology to detect trace molecular signatures of gliomas in CSF, enabling non-invasive preoperative diagnosis for glioma patients, assisting pathological diagnosis, and providing preoperative grading to guide surgical intervention.
Furthermore, in glioma surgery, the extent of resection is closely correlated with patient prognosis. Clinical practice has demonstrated that gliomas with different molecular subtypes derive varying benefits from surgical resection. With the advancement of rapid PCR technology, rapid detection of molecular markers can be achieved within 40 minutes. Based on the principles of rapid PCR, Kuoran Genetics has developed an intraoperative point-of-care molecular diagnostic product that can be performed synchronously with frozen section pathology to clarify the pathological diagnosis and guide surgical resection.
Mr. Zhang Rui candidly stated that patients with gliomas are predominantly concentrated in Grade 3A hospitals in first-tier cities, which has greatly facilitated product development, clinical validation, and promotional efforts, enabling Kuoran Genetics to efficiently secure a dominant market position through its stable diagnostic and therapeutic services.
In 2015, after more than a decade of experience in the healthcare industry, Mr. Bu Lingbin founded Kuoran Genomics in Zhangjiang, Shanghai.
In its early stages, Kuoran Genomics entered the market through a multi-omics research platform, gradually built and refined its R&D team, and began to venture into genetic testing and clinical testing for personalized medication.
Since 2018, Kuoran Genomics has partnered with leading medical institutions, including Huashan Hospital, Zhongshan Hospital, and Fudan University Shanghai Cancer Center (affiliated with Fudan University), as well as Ruijin Hospital and Renji Hospital (affiliated with Shanghai Jiao Tong University), to conduct whole-exome and transcriptome sequencing studies, while also providing tumor genetic testing services. Over the past three years, Kuoran Genomics’ independent clinical laboratories in Xuzhou and Shanghai have successively become operational. Leveraging its extensive genomic database, the company offers a one-stop molecular diagnostic solution for tumors across multiple application scenarios.
According to Mr. Bu Lingbin, Kuoran Genomics has cumulatively provided services to more than 500 hospitals and research institutions across China. At present, Kuoran Genomics is striving to deliver comprehensive solutions to hospitals based on the “LDT Services and IVD Products” model. On one hand, closely aligning with clinical guidelines and needs, the company focuses primarily on tumor molecular diagnostics by implementing high-standard performance validation processes, strict internal quality control standards, and comprehensive testing SOPs. It aims to transform mature LDT projects into IVD products, thereby establishing a dual-engine growth strategy driven by both LDTs and IVDs.
In the future, in addition to its full-cycle molecular diagnostic products for gliomas, Kuoran Gene has established a strategic presence in several areas, including preoperative early auxiliary diagnosis and postoperative recurrence risk assessment for liver cancer; detection of the tumor immune microenvironment for evaluating immunotherapy across major cancer types; assessment of multiple immunotherapy biomarkers using mIHC technology; and detection of major pathogens causing central nervous system infections based on qPCR. Meanwhile, Kuoran Gene is collaborating with government agencies to conduct large-scale national cohort clinical studies and is working with local governments, health examination centers, and medical institutions to explore more accessible and feasible solutions for early disease screening.
On the other hand, leveraging NGS and dPCR technologies, Kuoran Gene has established a diagnostic technology platform for intraoperative and postoperative use, deepening clinical application collaborations and advancing the NMPA registration of IVD products for liver cancer, intracranial tumors, and other major cancer types, thereby gradually building complementary market and brand advantages both within and outside hospitals.