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KRAS Mutation Detection with Reflex to BRAF Codon 600 Mutation Detection
2001932
Ordering Recommendation

Determine eligibility for anti-EGFR (cetuximab and panitumumab) therapy in patients with metastatic colorectal cancer.

Mnemonic
KRAS RFLX
Methodology
Polymerase Chain Reaction/Pyrosequencing
Performed
DNA isolation: Sun-Sat
Assay: Mon, Wed, Fri
Reported
10-14 days
New York DOH Approval Status
This test is New York DOH approved.
Submit With Order
Specimen Required
Patient Preparation
 
Collect
Tumor tissue. Also acceptable: DNA extracted by CLIA certified lab with corresponding client-circled H&E slide. 
Specimen Preparation
Tumor Tissue: Formalin fix (10 percent neutral buffered formalin) and paraffin embed tissue. Protect paraffin block from excessive heat. Tissue block will be returned after testing. Transport tissue block or 5 unstained 5-micron slides. (Min: 3 slides). Transport block and/or slide(s) in a tissue transport kit (ARUP Supply #47808) available online through eSupply using ARUP Connect™ or contact ARUP Client Services at (800) 522-2787.
Extracted DNA: Transport 40uL DNA with at least 50 ng/uL concentration. (Min: 40uL) Transport DNA in a tissue transport kit (ARUP Supply #47808) available online through eSupply using ARUP Connect™ or contact ARUP Client Services at (800) 522-2787. 
Storage/Transport Temperature
Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months.
Extracted DNA: Refrigerated. 
Unacceptable Conditions
Less than 25 percent tumor. DNA extracted by a non-CLIA lab. DNA extracted without a corresponding circled H&E slide. Specimens fixed/processed in alternative fixatives (alcohol, Prefer) or heavy metal fixatives (B-4 or B-5). Decalcified specimens. 
Remarks
Include surgical pathology report. 
Stability
Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable
Extracted DNA: Ambient: 1 month; Refrigerated: Indefinitely; Frozen: Indefinitely 
Reference Interval
Interpretive Data
Refer to report.

Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

Note
This test detects mutations in codons 12, 13, and 61. If KRAS is not detected, BRAF codon 600 Mutation Detection will be performed. Additional charges apply.
Hotline History
View Hotline History
CPT Code(s)
88381; 81275; 81276; If reflexed, add 81210
Components
Component Test Code*Component Chart NameLOINC
0040249KRAS Mutation Detection21702-6
2002148Block ID57723-9
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
  • Anti-EGFR therapy eligibility
  • anti-EGFR therapy resistance testing
  • BRAF codon 600
  • Cetuximab (Erbitux)
  • KRAS codons 12, 13, 61
  • Panitumumab (Vectibix)
  • RAS