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Methodology
Molecular
Test Description

The Cholangio/Pancreatic Carcinoma NGS Fusion Panel is an RNA-based next-generation sequencing panel that detects translocations and fusions with known and novel fusion partners of these genes: ALK, BRAF, CCDC6, FGFR2, NTRK1, NTRK2, NTRK3, NRG1, RAF1, RET, ROS1, and TACC3.

Clinical Significance

The Cholangio/Pancreatic Carcinoma NGS Fusion Panel is intended to detect gene fusions associated with cholangiocarcinoma and pancreatic carcinoma to aid in diagnosis, prognosis, and therapy selection.

Cholangiocarcinoma is an uncommon biliary tract cancer that typically presents at an advanced disease stage and is characterized by an aggressive disease course and poor clinical outcome. FGFR2 fusions are present up to 15% in cholangiocarcinoma and a prognostic indicator for survival and chemotherapy response.

Pancreatic cancer is a highly aggressive, recalcitrant malignancy with a 5-year survival of less than 9%. NRG1 fusions have been identified as a targetable oncogenic driver for pancreatic cancer. ALK and ROS1 fusions are also recommended for actionable targets.

NTRK fusions are rare in both cholangiocarcinoma and pancreatic cancers, but testing is of high interest due to possible treatment with specific TRK inhibitors (entrectinib, larotrectinib).

Specimen Requirements
  • FFPE tissue: Paraffin block is preferred. Alternatively, send 1 H&E slide plus 5-10 unstained slides cut at 5 or more microns. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives.
Storage and Transportation

Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

CPT Code(s)*
81445
Turnaround Time

21 Days

References
  1. Jain, A. et al. Cholangiocarcinoma With FGFR Genetic Aberrations: A Unique Clinical Phenotype. JCO Precision Oncology 2018:2, 1-12.
  2. Kuznar, W. FGFR2 Emerges as a Promising Target in Cholangiocarcinoma. Targeted Oncology. 2019:8
  3. Demols A et al. NTRK gene fusions in bilio-pancreatic cancers. Journal of Clinical Oncology 2020 38:15_suppl, e16664-e16664
Level of Service
Global

*The CPT codes provided with our test descriptions are based on AMA guidelines and are for informational purposes only. Correct CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.