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Test ID KRASW KRAS Somatic Mutation Analysis, Peritoneal Fluid


Shipping Instructions


Send specimens refrigerated (4° C)



Necessary Information


Pathology report (final or preliminary) is required and must accompany specimen for testing to be performed. At minimum, it should contain the following information:

1. Patient name and second identifier

2. Fluid collection date

3. Source of the fluid



Specimen Required


Container/Tube: 50-mL Falcon tube

Preferred: Fresh, peritoneal washing; no fixatives added to wash

Specimen Volume: Two 50-mL Falcon tubes

Collection Instructions: Containers must be labeled with two unique patient identifiers.


Forms

Molecular Genetics: Inherited Cancer Syndromes Patient Information (T519)

Secondary ID

616452

Useful For

Staging of the pancreatic ductal adenocarcinoma.(1)

Method Name

Droplet Digital Polymerase Chain Reaction (ddPCR)

Reporting Name

KRAS Mutation Analysis, Peritoneal

Specimen Type

Varies

Specimen Minimum Volume

100 mL of peritoneal washing

Specimen Stability Information

Specimen Type Temperature Time
Varies Refrigerated

Clinical Information

Pancreatic ductal adenocarcinoma (PDAC) is an aggressive malignancy with predilection for peritoneal dissemination. Accurate peritoneal staging is important for management of patients with PDAC. The Kirsten RAS (KRAS) oncogene is the most commonly mutated oncogene in pancreatic ductal adenocarcinoma (PDAC). Detection of KRAS mutations within peritoneal fluid has been associated with clinically positive laparoscopic findings (gross metastases and/or positive peritoneal cytology) and elevated peritoneal fluid CA19-9 and/or carcinoembryonic antigen and may portend an increased risk of residual/recurrent pancreatic cancer metastases within the peritoneal cavity.

 

This test uses DNA extracted from cells shed into the peritoneum to evaluate for the presence of KRAS (G12A, G12C, G12D, G12R, G12S, G12V, G13D, Q61K, Q61L, Q61R, Q61H, and A146T) mutations. A positive result indicates the presence of an activating KRAS mutation and can be a useful marker to aid in the staging of pancreatic ductal adenocarcinoma.

Reference Values

An interpretive report will be provided.

Cautions

Patients with a negative test result may still harbor a KRAS mutation below the level of detection.

 

The limit of detection of this assay is influenced by the amount of cells and DNA in the peritoneal wash. This is a biological variable that cannot be controlled.

 

This assay was designed to detect mutations in KRAS codons 12, 13, 61, and 146 (G12A, G12C, G12D, G12R, G12S, G12V, G13D, Q61K, Q61L, Q61R, Q61H, and A146T).

 

This test has not been clinically validated for use as a tool to monitor response to therapy or for early detection of tumors.

 

This test cannot differentiate between somatic and germline alterations.

Day(s) Performed

Monday through Friday

Report Available

4 to 10 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

81275-KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene) (eg, carcinoma) gene analysis, variants in codons 12 and 13

81276-KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene) (eg, carcinoma) gene analysis, additional variants

81479 (if appropriate for government payers)

NY State Approved

Yes