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Test ID KRASD Cell-Free DNA KRAS 12, 13, 61,146, Blood


Advisory Information


This test is not a prenatal screening test. To evaluate for the presence of common fetal chromosome abnormalities using cell-free DNA, order NIPS / Cell-Free DNA Prenatal Screen.



Shipping Instructions


1. Samples should be transported at ambient temperature or refrigerated (4° C).

2. Samples are viable for 7 days in the Streck Black/Tan Top Tube Kit (T715).



Specimen Required


Supplies: Streck Black/Tan Top Tube Kit (T715)

Container/Tube: Streck Cell-Free DNA blood collection kit (T715)

Specimen Volume: Two 10-mL Streck Cell-Free DNA blood collection tubes

Additional Information: Only blood collected in Streck Cell-Free DNA BCT tubes will be accepted for analysis. Whole blood will be processed to produce platelet-poor plasma before cfDNA isolation.


Useful For

As an alternative to invasive tissue biopsies for the determination of KRAS 12, 13, 61,146 (G12A, G12C, G12D, G12R, G12S, G12V, G13D, Q61K, Q61L, Q61R, Q61H, and A146T) mutation status

 

Selection of patients with colorectal cancer who are most likely to benefit from epidermal growth factor receptor (EGFR)-targeted therapies

Genetics Test Information

This test evaluates cell-free DNA (cfDNA) in the peripheral blood for the presence of KRAS mutations at codons 12, 13, 61, and 146 (G12A, G12C, G12D, G12R, G12S, G12V, G13D, Q61K, Q61L, Q61R, Q61H, and A146T) in patients with colorectal cancer and can be used to assess eligibility for targeted therapies.

 

This test is not validated for serial monitoring of patients with cancer. This test is also not intended as a screening test to identify cancer.

Highlights

This test provides rapid detection of KRAS mutations in colorectal cancer patients as an alternative for KRAS analysis of tissue.

 

Current data suggests that the efficacy of epidermal growth factor receptor (EGFR)-targeted therapy in colorectal cancer patients is limited to patients whose tumors do not harbor mutations in the KRAS gene.

Method Name

Digital Droplet Polymerase Chain Reaction (PCR)

Reporting Name

cfDNA KRAS 12, 13, 61, 146 Blood

Specimen Type

Whole blood

Specimen Minimum Volume

One 10 mL Streck tube

Specimen Stability Information

Specimen Type Temperature Time Special Container
Whole blood Ambient (preferred) 7 days Streck Black/Tan top
  Refrigerated  7 days Streck Black/Tan top

Day(s) and Time(s) Performed

 Monday through Friday; Varies

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. This test has not been cleared or approved by the U.S. Food and Drug Administration.

CPT Code Information

81275

81276

LOINC Code Information

Test ID Test Order Name Order LOINC Value
KRASD cfDNA KRAS 12, 13, 61, 146 Blood In Process

 

Result ID Test Result Name Result LOINC Value
113123 Result Summary 50397-9
113508 Result 75974-6
113125 Interpretation 69047-9
113126 Additional Information 48767-8
113127 Specimen 31208-2
113128 Source 31208-2
113129 Released By 18771-6

NY State Approved

Yes

Forms

If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.