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HelpTest Code KRASD Cell-Free DNA KRAS 12, 13, 61,146, Blood
Ordering Guidance
This test is not a prenatal screening test
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
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
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
Detecting molecular markers associated with response or resistance to specific therapy
This test is not intended as a screening test to identify cancer.
Method Name
Digital Droplet Polymerase Chain Reaction (PCR)
Reporting Name
cfDNA KRAS 12, 13, 61, 146 BloodSpecimen Type
Whole bloodSpecimen 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 |
Interpretation
The interpretation of molecular biomarker analysis includes an overview of the results and the associated diagnostic, prognostic, and therapeutic implications.
Clinical Reference
1. Schwarzenbach H, Hoon DS, Pantel K. Cell-free nucleic acids as biomarkers in cancer patients. Nat Rev Cancer. 2011;11(6):426-437
2. Allegra CJ, Rumble BR, Hamilton SR, et al. Extended RAS gene mutation testing in metastatic colorectal carcinoma to predict response to anti-epidermal growth factor receptor monoclonal antibody therapy: American Society of Clinical Oncology Provisional Clinical Opinion Update 2015. J Clin Oncol. 2016;34(2):179-185. doi:10.1200/JCO.2015.63.967
3. Olmedillas Lopez S, Garcia-Olmo DC, Garcia-Arranz M, et al. KRAS G12V mutation detection by droplet digital PCR in circulating cell-free DNA of colorectal cancer patients. Int J Mol Sci. 2016;17(4):484
4.Lam DC. Clinical testing for molecular targets for personalized treatment in lung cancer. Respirology. 2013 Feb;18(2):233-237
5.Hong DS, Fakih MG, Strickler JH, et al. KRAS G12C inhibition with sotorasib in advanced solid tumors. N Engl J Med. 2020;383(13):1207-1217
Day(s) Performed
Varies
Report Available
5 to 10 daysPerforming 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
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 |
Forms
If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.
Reference Values
An interpretive report will be provided