KRAS Mutation Detection with Reflex to BRAF Codon 600 Mutation Detection (INACTIVE as of 11/15/21: Refer to 0040248, 2002498)
Determine eligibility for anti-EGFR (cetuximab and panitumumab) therapy in patients with metastatic colorectal cancer.
Polymerase Chain Reaction/Pyrosequencing
DNA isolation: Sun-Sat
New York DOH Approval Status
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. 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.
If multiple specimens (blocks or slides) are sent to ARUP, they must be accompanied by one of the following: an order comment indicating that the ARUP pathologist should choose the specimen most appropriate for testing (e.g., "Choose best block"), or individual orders for each sample submitted. A Pathologist Block Selection Fee (ARUP test code 3002076) will be added to orders that utilize the first option. If multiple specimens are sent to ARUP without a request for pathologist block/slide selection or individual orders, they will be held until clarification is provided.
Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable
Extracted DNA: Ambient: 1 month; Refrigerated: Indefinitely; Frozen: Indefinitely
Refer to report.
This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.
Laboratory Developed Test (LDT)
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)