TEST CATALOG ORDERING & RESULTS SPECIMEN HANDLING CUSTOMER SERVICE EDUCATION & INSIGHTS
Test Catalog

Test ID: PRKAF    
Fibrolamellar Carcinoma, 19p13.1 (PRKACA) Rearrangement, FISH, Tissue

Useful For Suggests clinical disorders or settings where the test may be helpful

Aid in the diagnosis of identifying PRKACA gene rearrangements of patients with fibrolamellar carcinoma

Testing Algorithm Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

This test does not include a pathology consultation. If a pathology consultation is requested, PATHC / Pathology Consultation should be ordered and the appropriate FISH test will be ordered and performed at an additional charge.

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

DNAJB1-PRKACA fusion has been associated with a distinct subtype of hepatocellular carcinoma called fibrolamellar carcinoma. A break-apart strategy FISH probe has been developed to detect the rearrangement event that occurs in the DNAJB1-PRKACA fusion, specifically the loss of the 5' region labeled in red and retention of the 3' region labeled in green.

Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

An interpretive report will be provided.

Interpretation Provides information to assist in interpretation of the test results

A positive result with the PRKACA probe is detected when the percent of cells with an abnormality exceeds the normal cutoff for the probe set.

 

A positive result of PRKACA suggests fusion of the PRKACA and DNAJB1 genes at 19p13.1. A negative result suggests no fusion of the PRKACA and DNAJB1 genes has occurred.

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

This test is not approved by the US Food and Drug Administration, and it is best used as an adjunct to existing clinical and pathologic information.


Fixatives other than formalin (eg, Prefer, Bouin) may not be successful for FISH assays, however non-formalin fixed samples will not be rejected.


Paraffin-embedded tissues that have been decalcified are generally unsuccessful for FISH analysis. The pathologist reviewing the hematoxylin and eosin-stained slide may find it necessary to cancel testing.

Supportive Data

FISH analysis was performed on 60 formalin-fixed paraffin-embedded specimens including 10 fibrolamellar carcinoma tissue samples, 25 non-fibrolamellar carcinoma liver tumor samples, and 25 noncancerous control specimens. The normal controls were used to generate the normal cutoff values. Structural alterations resulting in the rearrangement of the PRKACA gene region were identified and results correlated with pathology and previous FISH findings.

Clinical Reference Recommendations for in-depth reading of a clinical nature

R Graham, L Jin, D Knutson, S Kloft-Nelson, et al: DNAJB1-PRKACA is specific for fibrolamellar carcinoma. Mod Path 2015;28:822-829