The Diagnostic Foundation of Precision Cancer Care
The Department of Pathology and Molecular Diagnostics at Fudan University Shanghai Cancer Center (FUSCC) is one of China's most distinguished and research-active cancer pathology programs, providing the diagnostic foundation upon which all cancer treatment decisions at FUSCC are built. With expertise spanning surgical pathology, cytopathology, dermatopathology, neuropathology, molecular pathology, next-generation sequencing (NGS), liquid biopsy, and immunohistochemistry, the department offers international patients access to some of China's most expert cancer pathologists and the most advanced molecular diagnostic technologies available.
For international patients seeking expert pathological review of cancer diagnoses — whether for a second opinion on a biopsy, comprehensive molecular profiling to guide treatment decisions, or access to specialized diagnostic tests not available in their home country — FUSCC's pathology and molecular diagnostics department represents one of the most compelling destinations in Asia. China Medical Concierge Shanghai (CMCS) provides seamless coordination for international patients requiring pathological consultation and molecular diagnostic services at FUSCC.
About the Department
FUSCC's pathology department is a national key clinical specialty processing tens of thousands of cancer specimens annually, including surgical resection specimens, core needle biopsies, fine needle aspirations, and liquid biopsy samples. The department operates a comprehensive surgical pathology laboratory, a cytopathology laboratory, a molecular pathology laboratory with NGS capabilities, an immunohistochemistry laboratory, a fluorescence in situ hybridization (FISH) laboratory, a liquid biopsy laboratory, and a tumor biobank.
The department's molecular pathology laboratory is one of the most advanced in China, providing the full range of companion diagnostic testing required for precision oncology treatment decisions across all major tumor types. Faculty members publish regularly in leading pathology and oncology journals including Journal of Pathology, Modern Pathology, Cancer Cell, Nature Medicine, and Journal of Clinical Oncology.
Diagnostic Services
Surgical Pathology & Expert Second Opinion
FUSCC's surgical pathology service provides expert histopathological diagnosis for all cancer types, with subspecialty expertise in:
- Breast Pathology — Invasive carcinoma subtyping; DCIS grading; ER, PR, HER2, and Ki67 scoring; oncotype DX and Mammaprint coordination; HER2 low and ultralow assessment
- Gastrointestinal Pathology — Colorectal, gastric, esophageal, hepatobiliary, and pancreatic cancer; GIST subtyping; neuroendocrine tumor grading
- Gynecologic Pathology — Ovarian, cervical, endometrial, and vulvar cancer; p53, MMR protein IHC; BRCA and HRD testing coordination
- Thoracic Pathology — Lung adenocarcinoma, squamous cell carcinoma, and SCLC subtyping; mesothelioma diagnosis; thymic tumor classification
- Head & Neck Pathology — Thyroid cancer subtyping; salivary gland tumor classification; HPV testing for oropharyngeal cancer; EBV testing for NPC
- Urological Pathology — Prostate cancer Gleason/ISUP grading; bladder cancer staging; renal tumor subtyping
- Soft Tissue & Bone Pathology — Sarcoma subtyping; molecular confirmation of diagnosis
- Hematopathology — Lymphoma and leukemia classification; WHO 2022 criteria
- Neuropathology — Brain tumor classification per WHO 2021 CNS tumor classification; IDH, MGMT, 1p/19q, TERT, ATRX, H3 K27M testing
Expert Second Opinion Service: International patients can submit digitized pathology slides or paraffin-embedded tissue blocks for expert second opinion review by FUSCC's subspecialty pathologists. This service is particularly valuable for:
- Rare or unusual tumor types requiring subspecialty expertise
- Discordant diagnoses between institutions
- Re-classification of tumors using updated WHO criteria
- Assessment of HER2 status in borderline (2+) cases
- Molecular testing not available at the referring institution
Immunohistochemistry (IHC)
FUSCC's IHC laboratory provides the full range of companion diagnostic and prognostic IHC testing:
- Predictive Biomarkers — ER, PR, HER2 (breast); PD-L1 (22C3, 28-8, SP142, SP263 clones); MMR proteins (MLH1, MSH2, MSH6, PMS2); CLDN18.2; HER2 (gastric/GEJ); ALK (lung); ROS1; MET; NTRK pan-TRK; BRAF V600E; IDH1 R132H; EGFR; AR
- Prognostic Markers — Ki67; p53; p16; SMAD4; CDX2; TTF-1; Napsin A; CK7; CK20; synaptophysin; chromogranin; CD56
- Tumor Origin Panels — IHC panels for cancer of unknown primary (CUP) to identify tissue of origin
Fluorescence In Situ Hybridization (FISH)
- HER2 FISH — For IHC 2+ equivocal cases in breast and gastric cancer
- ALK FISH — For ALK rearrangement confirmation in lung cancer
- ROS1 FISH — For ROS1 rearrangement in lung cancer
- FGFR2 FISH — For FGFR2 amplification in gastric and cholangiocarcinoma
- MYC, BCL2, BCL6 FISH — For double/triple-hit lymphoma diagnosis
- 1p/19q Co-deletion — For oligodendroglioma diagnosis
Next-Generation Sequencing (NGS) — Comprehensive Genomic Profiling
FUSCC's molecular pathology laboratory provides the full range of NGS-based molecular profiling for cancer patients:
- Targeted Gene Panels — Hot-spot mutation panels for EGFR, KRAS, NRAS, BRAF, PIK3CA, and other commonly mutated genes; rapid turnaround for urgent treatment decisions
- Comprehensive Genomic Profiling (CGP) — Large panel NGS (300-500+ genes) for identification of all actionable mutations, fusions, copy number alterations, TMB, and MSI; tissue and liquid biopsy platforms
- RNA Fusion Panel — RNA-based NGS for detection of ALK, ROS1, RET, NTRK, MET, FGFR2, and other gene fusions; superior sensitivity for fusion detection compared to DNA-based methods
- Whole Exome Sequencing (WES) — For research-grade comprehensive mutation profiling and neoantigen prediction
- Tumor Mutational Burden (TMB) — Quantitative TMB measurement for pembrolizumab eligibility in TMB-high solid tumors
- Microsatellite Instability (MSI) — PCR and NGS-based MSI testing for immunotherapy eligibility
- Homologous Recombination Deficiency (HRD) — myChoice CDx and other HRD assays for PARP inhibitor eligibility in ovarian and breast cancer
Liquid Biopsy (ctDNA)
FUSCC's liquid biopsy laboratory provides cell-free DNA (cfDNA) analysis from blood samples for:
- Treatment Monitoring — ctDNA dynamics as an early indicator of treatment response or resistance
- Resistance Mechanism Identification — Detection of acquired resistance mutations (e.g., EGFR T790M, C797S; ALK resistance mutations; ESR1 mutations) to guide next-line therapy selection
- Minimal Residual Disease (MRD) Detection — Post-surgical ctDNA for early detection of molecular recurrence before radiological progression
- Tumor Heterogeneity Assessment — Capturing clonal evolution and spatial heterogeneity not represented in a single tissue biopsy
- When Tissue Biopsy is Not Feasible — Molecular profiling when tumor tissue is insufficient or inaccessible
Germline Genetic Testing
- BRCA1/2 Germline Testing — For breast, ovarian, pancreatic, and prostate cancer patients
- Multi-Gene Hereditary Cancer Panels — PALB2, CHEK2, ATM, CDH1, PTEN, TP53, MLH1, MSH2, MSH6, PMS2, and other hereditary cancer genes
- Lynch Syndrome Testing — MMR gene sequencing and large rearrangement analysis
- RET Germline Testing — For medullary thyroid cancer and MEN2
- SDH Germline Testing — For pheochromocytoma and paraganglioma
- Genetic Counseling Coordination — Pre- and post-test genetic counseling; family cascade testing
Molecular Tumor Board
FUSCC's molecular tumor board meets weekly to review complex molecular profiling results and develop personalized treatment recommendations for patients with actionable genomic alterations. The board integrates pathological, oncological, and bioinformatics expertise to:
- Interpret complex or ambiguous molecular profiling results
- Identify off-label targeted therapy options based on molecular alterations
- Assess clinical trial eligibility based on molecular profile
- Recommend additional molecular testing when initial results are inconclusive
- Provide tumor-agnostic treatment recommendations for rare actionable alterations
Why International Patients Choose FUSCC Pathology & Molecular Diagnostics
- Expert Second Opinion — Subspecialty pathologist review of complex or unusual cancer diagnoses using the latest WHO classification criteria
- Comprehensive Molecular Profiling — Full range of NGS, IHC, FISH, and liquid biopsy testing under one roof
- Companion Diagnostic Expertise — All approved companion diagnostic tests for targeted therapy and immunotherapy eligibility
- Liquid Biopsy Leadership — ctDNA-based treatment monitoring, resistance detection, and MRD assessment
- Molecular Tumor Board — Expert interpretation of complex molecular results with actionable treatment recommendations
- Cost-Effectiveness — World-class molecular diagnostics at significantly lower cost than equivalent testing in Western countries
The CMCS Patient Journey
- Initial Inquiry — Share your pathology reports, prior molecular profiling results, and specific diagnostic questions with CMCS.
- Specimen Coordination — We coordinate the transfer of paraffin-embedded tissue blocks, unstained slides, or blood samples to FUSCC's laboratory.
- Test Selection — We work with FUSCC's pathology team to identify the most appropriate diagnostic tests based on your tumor type and clinical question.
- Priority Processing — We ensure expedited processing and reporting for time-sensitive treatment decisions.
- Results Translation — We translate and explain pathology and molecular profiling reports in plain language.
- Oncology Consultation — Where appropriate, we arrange a consultation with FUSCC's medical oncology team to discuss treatment implications of molecular profiling results.
- Molecular Tumor Board Submission — For complex cases, we facilitate review by FUSCC's molecular tumor board.
- Remote Follow-Up — Ongoing coordination for repeat liquid biopsy testing and treatment monitoring after you return home.
Book a Consultation
If you are seeking expert pathological review, molecular profiling, or a second opinion on a cancer diagnosis — CMCS can arrange access to FUSCC's pathology and molecular diagnostics services.
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