Clinical Molecular Medicine Testing Center

Department Profile: Clinical Molecular Medicine Testing Center

The Clinical Molecular Medicine Testing Center of the First Affiliated Hospital of Chongqing Medical University was established in 2012 with the approval of the former Chongqing Municipal Health Bureau as the “Chongqing Clinical Molecular Medicine Testing Center.” It was subsequently approved as the National Health Commission’s “First Group of Pilot Institutions for the Clinical Application of Prenatal Screening and Diagnosis Using High-Throughput Gene Sequencing,” the National Health Commission’s “Construction Institution for Gene-Diagnosis Laboratories under the Pilot Project for the Prevention and Control of Thalassemia,” and a “Core Institution of the China Precision Medicine Clinical Research and Application Alliance.” It is a molecular diagnostic laboratory integrating medical services, teaching, research, and technology transfer.

The Center has established a disciplinary team with strong professional competence, a well-balanced knowledge structure, and distinctive disciplinary characteristics, bringing together 40 multidisciplinary professionals from clinical medicine, clinical laboratory diagnostics, pathology and pathophysiology, pharmacy, molecular biology, bioinformatics, and other fields, including 1 person-time of a Chongqing Outstanding Young Scientist, 2 person-times of Chongqing young and middle-aged high-level talent, and 1 person-time under the Chongqing Medical Young Top Talent Program. The Center focuses, in response to the major needs of the development of the national healthcare system and the national independent innovation strategy, on the precise diagnosis of major and difficult diseases such as tumors, rare genetic diseases, infections, prenatal conditions, healthy reproduction and child-rearing, as well as common chronic diseases such as cardiovascular and cerebrovascular diseases and endocrine and metabolic diseases, leading the development of individualized molecular diagnostics in western China.

Group photo of all department staff

I. Clinical Services

(1) Advanced and Comprehensive Department Equipment

The Center’s laboratory covers 1,200 square meters and has established molecular diagnostic technology platforms including a pathology technology platform, a flow cytometry technology platform, a gene amplification platform, and a high-throughput sequencing technology platform. It is equipped with more than 100 internationally advanced pieces of equipment related to molecular testing, with instrumentation valued at more than 20 million yuan, including a microdissection instrument, a fully automated immunohistochemistry instrument, a fluorescence in situ hybridization instrument, a circulating tumor cell scanning and analysis system, a fluorescence quantitative PCR instrument, a digital PCR instrument, a first-generation sequencer, a high-throughput sequencer, a nucleic acid time-of-flight mass spectrometer, a flow cytometric cell-sorting and analysis system, and a large number of other high-end instruments.

Pathology Technology Platform Flow Cytometry Technology Platform Gene Amplification Platform High-Throughput Sequencing Platform

The Center has adopted “efficiency, standardization, precision, and innovation” as its quality policy. In accordance with the requirements for gene amplification laboratories, it has established a complete quality management system, passed on-site acceptance for a gene amplification laboratory, and has consistently operated under a comprehensive quality management system to ensure the accuracy of test results.

(2) Business Capabilities

The Center carries out more than 200 molecular diagnostic projects, including molecular pathology of solid tumors, MICM classification of hematologic tumors, hereditary rare diseases and prenatal screening, and drug-metabolism genes. It receives specimens from this hospital, Chongqing, and surrounding provinces and municipalities (Guizhou, Yunnan, Sichuan, etc.), and its annual testing volume reaches 500,000 test instances. It has explored a new multidisciplinary collaboration model oriented toward the precision diagnosis and treatment of major clinical diseases, laying a solid foundation for precision medicine. It has participated many times with clinical departments in domestic MDT lectures and academic exchanges, actively promoting 15 MDT teams for lung nodules and lung cancer, gastrointestinal stromal tumors, hematologic tumors, and thyroid cancer, as well as patient education activities. It has become the individualized molecular diagnostic laboratory and molecular R&D and technology-transfer platform in Chongqing with the most complete technology platforms, the most comprehensive range of projects, and the broadest outreach capacity, leading the development of individualized molecular diagnostics in western China.

(1) Personnel Team

The Center attaches great importance to the development of its disciplinary team and personnel, and after more than ten years of construction and development, it has established a disciplinary team with strong professional competence, a well-balanced knowledge structure, and distinctive disciplinary characteristics. It brings together technical personnel from multiple disciplines and specialties, including clinical medicine, clinical laboratory diagnostics, pathology and pathophysiology, pharmacy, genetics, molecular biology, and bioinformatics. It currently has 40 professional and technical personnel, including 3 with senior professional titles, 12 with intermediate professional titles, 11 postdoctoral fellows, 11 doctoral degree holders, and 15 master’s degree holders; the average age is 33. Eighteen hold clinical physician qualification certificates in the pathology testing specialty, 21 are qualified to provide demonstration teaching to undergraduate students in laboratory medicine, and all laboratory technicians hold PCR certificates for taking up their posts.

Team members have held academic positions on multiple occasions in academic organizations at various levels, including positions such as deputy chair and member on more than 10 national-, provincial-, and municipal-level academic committees, including the Molecular Diagnostics Group of the Laboratory Medicine Branch of the Chinese Medical Association, the Tumor Marker Special Committee of the Chinese Anti-Cancer Association, the Special Committee on Molecular Diagnostic Medicine of the Chinese Research Hospital Association, and the Laboratory Medicine Special Committee of the Chinese Association of Integrated Traditional and Western Medicine.

II. Teaching Work

The Center has 2 postdoctoral co-supervisors, 2 doctoral supervisors, and 3 master’s supervisors. It undertakes undergraduate graduation thesis supervision in laboratory medicine at its university, as well as medical education for the training of master’s, doctoral, and postdoctoral students in clinical laboratory diagnostics and other university medical education work. It undertakes the training of laboratory medicine visiting trainees and teaching work for continuing education and training in laboratory medicine, molecular diagnostics, and other fields.

It is the chief editor of the national-level planned undergraduate textbook for general higher education under the 14th Five-Year Plan, *Clinical Laboratory Instruments and Techniques*; a co-editor of the national planned textbook *Precision Medicine: Outline of Drug Therapy*; and a co-editor of Shanghai Jiao Tong University Press publications *Clinical Application of Molecular Testing and Precision Medicine* and *Clinical Precision Molecular Diagnostics*, as well as China Population Publishing House’s *Commonly Used Clinical Molecular Biology Testing Techniques*, among others. It has cumulatively trained more than 20 master’s students and 6 doctoral students, supervised the graduation theses of more than 20 undergraduates, including 2 recipients of the Chongqing Outstanding Graduate and Chongqing Outstanding Graduation Thesis awards, and trained more than 40 visiting trainees.

III. Research Work

The team’s core personnel have long engaged in research on new molecular diagnostic technologies, HBV molecular biology, tumor markers, and their clinical applications, and have independently developed and implemented 56 laboratory-developed test (LDT) reagent assays for clinical molecular diagnostics. The team has successively led more than 30 national-, provincial-, and ministerial-level projects, published 146 SCI papers, and obtained a cumulative total of ≥5 granted national and international invention patents. It has co-edited 17 academic monographs. It has received talent designations including Chongqing Outstanding Young Scientist, Chongqing High-Level Young and Middle-Aged Medical Talent, and Chongqing Medical Young Top Talent, and has received awards including the Ministry of Education Higher Education Institutions Scientific Research Outstanding Achievement Award, the Chongqing Natural Science First Prize, and the Chinese Medical Science and Technology Award. Its members serve as editorial board members and reviewers for multiple SCI and other journals.