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Oncology Drug Research, Development, and Manufacturing
The 2nd China International Import Expo (hereinafter referred to as the “CIIE”) has officially kicked off. Roche Diagnostics and Roche Pharmaceuticals, as two core businesses of the Roche Group, once again jointly participated in this grand event, showcasing innovative products and comprehensive solutions in the field of personalized medicine on a 700-square-meter exhibition stand.
Yao Guoliang, General Manager of Roche Diagnostics China, stated, “The China International Import Expo (CIIE) is a significant initiative in China’s market opening-up. It not only embodies the new expectations of global enterprises for the Chinese market but also brings new opportunities for development across various industries. Having grown alongside the Chinese market for nearly two decades, China has become one of Roche’s most important strategic hubs globally. We attach great importance to the CIIE as a global trade and exchange platform. Through this prestigious event, we aim to accelerate the introduction of more innovative in vitro diagnostic technologies in China, benefiting more Chinese patients and contributing to the ‘Healthy China 2030’ strategy.”

Pictured: Mr. Yao Guoliang, General Manager of Roche Diagnostics China
Roche Showcases Latest In Vitro Diagnostic Technologies, Bringing New Hope for Cancer Diagnosis and Treatment
In vitro diagnostics (IVD) involves the testing of human samples such as body fluids, blood, urine, and tissues to obtain objective information regarding health and disease, playing a pivotal role in clinical treatment decision-making. Currently, IVD technologies are being widely applied in the diagnosis and treatment of tumors. Particularly in the era of personalized medicine, the importance of companion diagnostics has become increasingly prominent. This innovative IVD concept enables physicians to determine the molecular subtyping of a patient’s cancer and select targeted therapeutic agents, thereby facilitating “differentiated treatment for the same type of cancer” and allowing patients to benefit from more effective personalized medical solutions.
Roche’s integrated strengths in diagnostics and pharmaceuticals have positioned it as a pioneer and leader in the advancement of personalized medicine. At this year’s China International Import Expo (CIIE), Roche Diagnostics showcased its latest innovations in oncology diagnostics, including companion diagnostic products for immunotherapy and targeted therapy. Through this exhibition, Roche aims to raise public awareness of the critical role that cutting-edge diagnostic technologies play in cancer diagnosis and treatment.

Since its inception, cancer immunotherapy has garnered widespread attention, particularly in the past two years as various immunotherapeutic agents have been sequentially approved for market launch in China, sparking considerable public discussion. In reality, however, precise testing constitutes the first step toward achieving precision medicine. The VENTANA PD-L1 (SP263) Assay Kit showcased by Roche Diagnostics is designed to detect PD-L1 expression in lung cancer and urothelial carcinoma, supporting companion diagnostic testing for three mainstream immunotherapeutic drugs. It is currently the companion diagnostic product associated with the largest number of immunotherapies worldwide and is expected to receive regulatory approval for market launch in China by early next year. Additionally, the VENTANA PD-L1 (SP142) Assay Kit is the first globally approved companion diagnostic for immunotherapy in triple-negative breast cancer (TNBC). For a long time, chemotherapy was virtually the only treatment option for patients with metastatic TNBC. Recently, the advent of Roche Diagnostics’ PD-L1 (SP142) companion diagnostic alongside Roche Pharma’s immunotherapy drug Tecentriq has brought new hope to patients with triple-negative breast cancer.
Lung cancer is the leading cause of both incidence and mortality among all cancers in China. Lung cancer can be classified into small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC), with the latter accounting for approximately 80–85% of all lung cancer cases. NSCLC is further subdivided into lung adenocarcinoma, squamous cell carcinoma of the lung, and large cell carcinoma. Among Chinese patients with lung cancer, lung adenocarcinoma accounts for 50.1%, and squamous cell carcinoma accounts for 33.4%. Approximately 50% of patients with lung adenocarcinoma harbor EGFR mutations. Targeted therapy is currently the most effective treatment approach for patients with EGFR mutations. This year, Roche Diagnostics’ next-generation cobas EGFR V2 Test Kit officially received approval in China for use with plasma samples, making it a tumor genetic testing product compatible with both tissue and plasma specimens. Testing using plasma samples offers new hope for patients from whom tumor tissue samples cannot be obtained surgically. The product is also approved by both China’s National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) as a companion diagnostic for EGFR-targeted therapies such as Tarceva®, Tagrisso®, and Iressa®, all of which are indicated for first-line treatment of EGFR mutation-positive non-small cell lung cancer.

The Latest Digital Solution for Multidisciplinary Oncology Consultation: Opening a New Era in Disease Management
In recent years, digitalization has become a focal point across various industries. Roche Diagnostics is also actively exploring digital transformation and developing more digital products to support clinical decision-making. At the China International Import Expo (CIIE), Roche unveiled its newly launched NAVIFY Tumor Board, a multidisciplinary tumor board platform. As Roche’s first digital product, it not only assists physicians in multidisciplinary oncology teams in organizing all relevant clinical data for patients but also leverages a robust database to provide global clinical guidelines, clinical research findings, and other resources that are continuously updated, thereby serving as an “intellectual hub” for physicians participating in multidisciplinary oncology consultations.

Figure: NAVIFY Tumor Board 2.0
Intelligent Solutions for Building “Smart” Laboratories
The continuous rise in demand for medical services has imposed higher requirements on testing processes and management. Laboratory management is facing multifaceted pressures and severe challenges, with increasing attention being paid to the concepts of automation, systematization, and lean management. The MyLab+ intelligent laboratory management solution is Roche Diagnostics’ customized smart solution for laboratories, built on automation and integrated with lean management principles as well as advanced technologies such as big data and artificial intelligence. For clinicians and patients, MyLab+ enables faster access to test reports. This is particularly critical for emergency conditions such as myocardial infarction, where earlier availability of highly accurate test results can save more lives. Additionally, the testing menu includes tumor-related markers, and these results assist physicians in diagnosing and treating patients.

Over the nearly 20 years since Roche Diagnostics entered the Chinese market, the company has consistently aligned its own growth with China’s healthcare reform and development. Alongside the robust expansion of China’s healthcare industry and the in vitro diagnostics (IVD) sector, China has become Roche Diagnostics’ second-largest global market and one of the key markets for its sustained investment.
Mr. Yao Guoliang, General Manager of Roche Diagnostics China, emphasized, “The holding of the China International Import Expo (CIIE) demonstrates China’s determination to continue opening its market and sharing the future with the world, while also revealing greater opportunities for multinational enterprises to develop in China. Roche Diagnostics remains passionate and confident about this open and ever-evolving market. Rooted here, we will continuously innovate to enrich our in vitro diagnostic solutions, advance healthcare, and help Chinese patients and physicians address more questions related to diseases.”