Pancreatic Cancer

Synonyms: -

Material:

FFPE tissue sections

TAT:

varies depending on the analysis

Method:

NGS

Overview

Pancreatic cancer accounted for an estimated 531,318 new cases worldwide in 2024 and was the 11th most commonly diagnosed cancer globally. Pancreatic ductal adenocarcinoma (PDAC) is the predominant malignant epithelial tumour of the pancreas. Molecular profiling of tumour tissue can identify clinically actionable or emerging alterations that may inform treatment selection and eligibility for molecularly guided clinical trials.

Clinical background and relevance

The classification of pancreatic neoplasms is based primarily on the direction of tumour-cell differentiation, including ductal, acinar and neuroendocrine differentiation, together with the gross configuration of the lesion. Because distinct pancreatic tumour entities have different molecular characteristics, histopathological classification should precede and guide the selection and interpretation of molecular tests. Nearly 90% of malignant pancreatic neoplasms in adults are invasive ductal adenocarcinomas.

Current NCCN Guidelines recommend tumour/somatic molecular profiling, preferably using a validated next-generation sequencing assay, for all patients with pancreatic adenocarcinoma who are candidates for anticancer therapy. Testing should be initiated sufficiently early for potentially actionable results to be available when treatment decisions are made. Clinically relevant findings may include sequence variants, gene fusions or rearrangements, copy-number alterations, microsatellite instability, mismatch repair deficiency and tumour mutational burden.

Genetic testing for inherited cancer susceptibility is recommended for every patient with confirmed pancreatic cancer. Germline testing and tumour profiling are complementary. Tumour-only testing cannot always establish whether a detected variant is somatic or germline. A tumour finding with potential hereditary significance should therefore prompt evaluation in constitutional DNA and genetic counselling in accordance with applicable guidelines.

Tumour tissue is the preferred specimen for molecular profiling when adequate material is available. A core biopsy is recommended where possible to obtain sufficient material for molecular profiling and other ancillary studies.

Oncogenic KRAS variants are present in approximately 90% of conventional PDACs. KRAS-wild-type PDACs are enriched for alternative oncogenic drivers, including clinically relevant fusions and alterations involving BRAF, ERBB2/HER2, FGFR2, NRG1, NTRK1, NTRK2, NTRK3, ALK, RET and ROS1. The prevalence of individual alterations varies according to patient population, histological classification and testing methodology.

Pathogenic alterations in homologous recombination repair genes, particularly BRCA1, BRCA2 and PALB2, may have therapeutic and hereditary implications. Their interpretation must consider variant classification, germline status, zygosity or evidence of biallelic inactivation, and gene-specific clinical evidence. Detection of an alteration in an HRR-associated gene is not, by itself, equivalent to demonstration of a homologous recombination-deficient phenotype.

MSI-high and mismatch repair-deficient PDACs are rare, generally accounting for less than 1% of conventional PDACs, but their identification may have therapeutic implications. MSI can be assessed using a validated molecular assay, whereas loss of MMR protein expression is generally assessed by immunohistochemistry. MSI-H and dMMR are closely related but should not be treated as analytically interchangeable terms.

Available tests

The analyses listed below may be ordered individually or, where applicable, as part of a combined molecular analysis. The assays described here represent a focused set of biomarkers and do not replace comprehensive biomarker profiling when broader testing is clinically indicated.

Single-method analyses	Panel	Gene scope	Purpose
Sequencing	Panel00741	BRAF, BRCA1, BRCA2, KRAS, PALB2	Detection of somatic sequence variants in tumour tissue
Fusion gene analysis	Panel00745	ALK, FGFR2, NTRK1, NTRK2, NTRK3, RET, ROS1	Detection of gene fusions in tumour tissue
Microsatellite instability (MSI) analysis	Panel00744	Microsatellite marker analysis	Determination of tumour microsatellite instability (MSI) status

	Panel	Gene scope
Combined focused analysis	Panel00540	BRAF, BRCA1, BRCA2, KRAS, PALB2, ALK, FGFR2, NTRK1, NTRK2, NTRK3, RET, ROS1

Additional molecular genetic analyses on tumour tissue, e.g., the determination of tumour mutational burden (TMB) and homologous recombination deficiency (HRD) are also available (see Panel 00617 – ).

Therapy

References

Created by

Our editorial team consists of medical specialists and scientists in the field of human genetics. All content is created and reviewed in accordance with current scientific standards.

Last Update : 24.09.2026

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