Test Details
Methodology
SNaPshot Multiplex PCR (primer extension-based method)
Result Turnaround Time
5 - 7 days
Use
NRAS is a guanosine triphosphate (GTP)-binding protein involved in downstream receptor signaling, which is critical for cell proliferation, survival and differentiation. Mutations in the NRAS oncogene are frequently found in human cancers. They are common in melanomas, colorectal cancer and thyroid cancer. This assay detects NRAS mutations in exons 2, 3 and 4, allowing the determination of drug response.
Special Instructions
Provide a copy of the pathology report; the NRAS test will be delayed if the pathology report is not received. Direct any questions regarding this test to customer service at 800-345-4363.
Specimen Requirements
Limitations
This assay is able to detect 5% mutation in a background of wild-type DNA.
This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.
References
Bae JS, Choi SK, Jeon S, et al. Impact of NRAS mutations on the diagnosis of follicular neoplasm of thyroid. Int J Endocrinol. 2014:289834. 25254041
Benson AB 3rd, Bekaii-Saab T Chan E, et al. Rectal cancer. J Natl Compr Canc Netw. 2012 Dec 1;10(12):1528-1564. 23221790
Benson AB 3rd, Venook AP, Bekaii-Saab T, et al. Colon cancer, version 3.2014. J Natl Compr Canc Netw. 2014 Jul;12(7):1028-1059. 24994923
Bokemeyer C, Van Cutsem E, Rougier P, et al. Addition of cetuximab to chemotherapy as first-line treatment for KRAS wild-type metastatic colorectal cancer. Pooled analysis of the CRYSTAL and OPUS randomized clinical trials. Eur J Cancer. 2012 Jul; 48(10):1466-1475. 22446022
Douillard JY, Siena S, Cassidy J, et al. Randomized, phase III trial of panitumumab with fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as first-line treatment in patients with previously untreated metastatic colorectal cancer: The PRIME study. J Clin Oncol. 2010 Nov 1;28(31):4697-4705. 20921465
Thumar J, Shahbazian D, Aziz SA, Jilaveanu LB, Kluger HM. MEK targeting in N-RAS mutated metastatic melanoma. Mol Cancer. 2014 Mar 4;13:45-54. 24588908
Specimen
Formalin-fixed, paraffin-embedded (FFPE) tissue or slides
Volume
Formalin-fixed, paraffin-embedded tissue block or four unstained slides and one matching H&E-stained slide at 5 μM
Minimum Volume
Two unstained slides and one matching H&E-stained slide at 5 μM; samples with >4mm² and ≥50% tumor content are preferred
Container
Formalin-fixed, paraffin-embedded (FFPE) tissue blocks or slides
Storage Instructions
Maintain blocks/slides at room temperature.
Causes for Rejection
Tumor block containing insufficient tumor tissue; broken or stained slides
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 570168 | NRAS Extended Analysis | 570169 | Referring Physician | 18781-5 | ||
| 570168 | NRAS Extended Analysis | 570170 | Treating Physician | 18781-5 | ||
| 570168 | NRAS Extended Analysis | 570171 | Body Site | 39111-0 | ||
| 570168 | NRAS Extended Analysis | 570172 | Client Specimen ID | N/A | ||
| 570168 | NRAS Extended Analysis | 570173 | Specimen(s) Received | 31208-2 | ||
| 570168 | NRAS Extended Analysis | 570174 | Clinical Data | 55752-0 | ||
| 570168 | NRAS Extended Analysis | 570175 | Results: | 50397-9 | ||
| 570168 | NRAS Extended Analysis | 570176 | Interpretation | 62365-2 | ||
| 570168 | NRAS Extended Analysis | 570177 | Analytical Results | 21702-6 | ||
| 570168 | NRAS Extended Analysis | 570178 | Comments | 77202-0 | ||
| 570168 | NRAS Extended Analysis | 570179 | Methodology: | 49549-9 | ||
| 570168 | NRAS Extended Analysis | 570180 | References: | 75608-0 | ||
| 570168 | NRAS Extended Analysis | 570181 | Signed By | 19139-5 | ||
| 570168 | NRAS Extended Analysis | 570182 | Disclaimers | N/A | ||
| 570168 | NRAS Extended Analysis | 570183 | 11502-2 | |||
| 570168 | NRAS Extended Analysis | 570184 | Bill Code Entry Hold | N/A | ||
| Order Code | 570168 | |||||
| Order Code Name | NRAS Extended Analysis | |||||
| Order Loinc | ||||||
| Result Code | 570169 | |||||
| Result Code Name | Referring Physician | |||||
| UofM | ||||||
| Result LOINC | 18781-5 | |||||
| Order Code | 570168 | |||||
| Order Code Name | NRAS Extended Analysis | |||||
| Order Loinc | ||||||
| Result Code | 570170 | |||||
| Result Code Name | Treating Physician | |||||
| UofM | ||||||
| Result LOINC | 18781-5 | |||||
| Order Code | 570168 | |||||
| Order Code Name | NRAS Extended Analysis | |||||
| Order Loinc | ||||||
| Result Code | 570171 | |||||
| Result Code Name | Body Site | |||||
| UofM | ||||||
| Result LOINC | 39111-0 | |||||
| Order Code | 570168 | |||||
| Order Code Name | NRAS Extended Analysis | |||||
| Order Loinc | ||||||
| Result Code | 570172 | |||||
| Result Code Name | Client Specimen ID | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||
| Order Code | 570168 | |||||
| Order Code Name | NRAS Extended Analysis | |||||
| Order Loinc | ||||||
| Result Code | 570173 | |||||
| Result Code Name | Specimen(s) Received | |||||
| UofM | ||||||
| Result LOINC | 31208-2 | |||||
| Order Code | 570168 | |||||
| Order Code Name | NRAS Extended Analysis | |||||
| Order Loinc | ||||||
| Result Code | 570174 | |||||
| Result Code Name | Clinical Data | |||||
| UofM | ||||||
| Result LOINC | 55752-0 | |||||
| Order Code | 570168 | |||||
| Order Code Name | NRAS Extended Analysis | |||||
| Order Loinc | ||||||
| Result Code | 570175 | |||||
| Result Code Name | Results: | |||||
| UofM | ||||||
| Result LOINC | 50397-9 | |||||
| Order Code | 570168 | |||||
| Order Code Name | NRAS Extended Analysis | |||||
| Order Loinc | ||||||
| Result Code | 570176 | |||||
| Result Code Name | Interpretation | |||||
| UofM | ||||||
| Result LOINC | 62365-2 | |||||
| Order Code | 570168 | |||||
| Order Code Name | NRAS Extended Analysis | |||||
| Order Loinc | ||||||
| Result Code | 570177 | |||||
| Result Code Name | Analytical Results | |||||
| UofM | ||||||
| Result LOINC | 21702-6 | |||||
| Order Code | 570168 | |||||
| Order Code Name | NRAS Extended Analysis | |||||
| Order Loinc | ||||||
| Result Code | 570178 | |||||
| Result Code Name | Comments | |||||
| UofM | ||||||
| Result LOINC | 77202-0 | |||||
| Order Code | 570168 | |||||
| Order Code Name | NRAS Extended Analysis | |||||
| Order Loinc | ||||||
| Result Code | 570179 | |||||
| Result Code Name | Methodology: | |||||
| UofM | ||||||
| Result LOINC | 49549-9 | |||||
| Order Code | 570168 | |||||
| Order Code Name | NRAS Extended Analysis | |||||
| Order Loinc | ||||||
| Result Code | 570180 | |||||
| Result Code Name | References: | |||||
| UofM | ||||||
| Result LOINC | 75608-0 | |||||
| Order Code | 570168 | |||||
| Order Code Name | NRAS Extended Analysis | |||||
| Order Loinc | ||||||
| Result Code | 570181 | |||||
| Result Code Name | Signed By | |||||
| UofM | ||||||
| Result LOINC | 19139-5 | |||||
| Order Code | 570168 | |||||
| Order Code Name | NRAS Extended Analysis | |||||
| Order Loinc | ||||||
| Result Code | 570182 | |||||
| Result Code Name | Disclaimers | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||
| Order Code | 570168 | |||||
| Order Code Name | NRAS Extended Analysis | |||||
| Order Loinc | ||||||
| Result Code | 570183 | |||||
| Result Code Name | ||||||
| UofM | ||||||
| Result LOINC | 11502-2 | |||||
| Order Code | 570168 | |||||
| Order Code Name | NRAS Extended Analysis | |||||
| Order Loinc | ||||||
| Result Code | 570184 | |||||
| Result Code Name | Bill Code Entry Hold | |||||
| UofM | ||||||
| Result LOINC | N/A |
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 057168 | NRAS Extended Analysis (B) | 000000 | Results | Pending | |
| Reflex 1 | ||||||
| Order Code | 057168 | |||||
| Order Name | NRAS Extended Analysis (B) | |||||
| Result Code | 000000 | |||||
| Result Name | Results | |||||
| UofM | ||||||
| Result LOINC | Pending | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 057168 | NRAS Extended Analysis (B) | 000000 | Results | Pending | |
| Reflex 1 | ||||||
| Order Code | 057168 | |||||
| Order Name | NRAS Extended Analysis (B) | |||||
| Result Code | 000000 | |||||
| Result Name | Results | |||||
| UofM | ||||||
| Result LOINC | Pending | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 057168 | NRAS Extended Analysis (B) | 000000 | Results | Pending | |
| Reflex 1 | ||||||
| Order Code | 057168 | |||||
| Order Name | NRAS Extended Analysis (B) | |||||
| Result Code | 000000 | |||||
| Result Name | Results | |||||
| UofM | ||||||
| Result LOINC | Pending | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 057168 | NRAS Extended Analysis (B) | 000000 | Results | Pending | |
| Reflex 1 | ||||||
| Order Code | 057168 | |||||
| Order Name | NRAS Extended Analysis (B) | |||||
| Result Code | 000000 | |||||
| Result Name | Results | |||||
| UofM | ||||||
| Result LOINC | Pending | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 057168 | NRAS Extended Analysis (B) | 000000 | Results | Pending | |
| Reflex 1 | ||||||
| Order Code | 057168 | |||||
| Order Name | NRAS Extended Analysis (B) | |||||
| Result Code | 000000 | |||||
| Result Name | Results | |||||
| UofM | ||||||
| Result LOINC | Pending | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 057168 | NRAS Extended Analysis (B) | 000000 | 11526-1 | ||
| Reflex 1 | ||||||
| Order Code | 057168 | |||||
| Order Name | NRAS Extended Analysis (B) | |||||
| Result Code | 000000 | |||||
| Result Name | ||||||
| UofM | ||||||
| Result LOINC | 11526-1 | |||||