World's First! Fudan University Shanghai Cancer Center Self-Develops and Files Pancreatic Cancer 6-Gene Mutation Detection Kit

Background

Pancreatic cancer is known as the "king of cancers" due to its high malignancy, rapid progression and often hidden early symptoms. Clinical data referenced in reports indicate that the majority of patients are diagnosed at an advanced stage, at which point opportunities for curative surgery are typically lost and five-year survival rates remain low.

With the development of precision medicine, targeted therapies and immunotherapies guided by genetic detection have shown efficacy for pancreatic cancer. Traditional detection methods, however, usually focus on single or a limited number of genes. Reports describe this as akin to searching a small area with a magnifying glass, which can miss the full spectrum of mutation features in pancreatic cancer driver pathways. These approaches can also have limitations in sensitivity, specificity and testing duration, restricting timely options for patients.

What was achieved

On December 31, 2025, the "Human Pancreatic Cancer 6-Gene Mutation Detection Kit" independently developed by a team led by Professor Xianjun Yu, president of Fudan University Shanghai Cancer Center, formally passed filing with the Shanghai Municipal Medical Products Administration.

It is one of the first batch of hospital-developed in vitro diagnostic reagents approved for self-use by medical institutions in China. Multiple sources, including the hospital's English-language newsroom, describe it as the world's first medical institution-developed IVD reagent with a clear indication specifically for pancreatic cancer. Professor Xin Hu, deputy director of the hospital's Precision Oncology Center, led the technical personnel. The interdisciplinary team centered its work on the molecular characteristics of pancreatic cancer in Chinese populations and completed the project after three years of technical development.

How it works

The kit combines next-generation sequencing technology, ultra-deep capture technology and paired analysis strategies. For a general audience, next-generation sequencing rapidly reads genetic information. Ultra-deep capture enriches and deeply examines selected DNA regions of interest so that mutations, even those present at low levels, can be identified. Paired analysis compares samples to improve accuracy and reduce errors.

It targets six core mutant genes in the driver pathways of pancreatic cancer. This provides a more comprehensive gene variation profile than traditional methods that typically examine fewer genes. Reports state that the approach significantly improves mutation detection rates while achieving higher sensitivity and specificity and a shorter detection cycle than conventional testing. The resulting molecular map supplies clinicians with information to support individualized treatment decisions and prognostic evaluation, including for patients with advanced disease.

What it means for international patients

The filing of this kit represents an institutional effort to address gaps in the precise molecular diagnosis of pancreatic cancer. Sources indicate it offers a potential Chinese contribution to precision approaches for a cancer with limited treatment options in many cases by enabling better identification of actionable mutations early or in advanced stages.

Fudan University Shanghai Cancer Center operates an International Medical Center and VIP outpatient services that accept foreign patients using passports and provide interpreter support, including in English. International patients interested in this detection kit or associated precision pancreatic cancer care must confirm current availability, eligibility and integration into clinical pathways directly with the hospital, as these details for overseas patients are not specified in public reports.

About the hospital

Fudan University Shanghai Cancer Center is located in Shanghai with campuses in Xuhui and Pudong districts. Affiliated with Fudan University and founded in 1931, it is one of the earliest tertiary specialized cancer hospitals in China and functions as a national cancer center. It is a Grade A tertiary hospital focused exclusively on oncology.

The center specializes in cancer prevention, screening, diagnosis, treatment and research with noted strengths in precision oncology, multidisciplinary teams and pancreatic cancer. It has established a Precision Oncology Center and is advancing its role as an integrated clinical-research-education institution aiming for international standards in precision medicine. Dedicated services for international patients are available through its International Medical Center.