Determine eligibility for anti-EGFR (cetuximab and panitumumab) therapy in patients with metastatic colorectal cancer.
Polymerase Chain Reaction/Pyrosequencing
DNA isolation: Sun-Sat
Assay: Mon, Wed, Fri
Tumor tissue. Also acceptable: DNA extracted by CLIA certified lab with corresponding client-circled H&E slide.
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.
Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months.
Extracted DNA: Refrigerated.
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.
Include surgical pathology report.
Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable
Extracted DNA: Ambient: 1 month; Refrigerated: Indefinitely; Frozen: Indefinitely
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.
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.
88381; 81275; 81276; If reflexed, add 81210
|Component Test Code*||Component Chart Name||LOINC|
|0040249||KRAS Mutation Detection||21702-6|
- Anti-EGFR therapy eligibility
- anti-EGFR therapy resistance testing
- BRAF codon 600
- Cetuximab (Erbitux)
- KRAS codons 12, 13, 61
- Panitumumab (Vectibix)