| A B C D E F G H I J K L M N O P Q R S T U V W X Y Z # |
RAS Mutation Analysis, Cell-based
Test Code16128
CPT Codes
81275, 81276, 81311, 81403
Includes
HRAS Mutation, Cell-based; KRAS Mutation, Cell-based; NRAS Mutation, Cell-based
Preferred Specimen
Formalin-fixed paraffin embedded tissue
Minimum Volume
3 mL whole blood • 1 mL bone marrow aspirate • 4 slides
Other Acceptable Specimens
5 mL whole blood collected in an EDTA (lavender-top) tube, or sodium heparin (green-top) tube • 3 mL bone marrow aspirate collected in an EDTA (lavender-top) tube, or sodium heparin (green-top) tube • 8 unstained positively charged slides
Instructions
Submission of formalin-fixed, paraffin-embedded tissue is the preferred sample type. Other sample types listed are acceptable for testing. For submission of paraffin block, another preferred specimen type, tissue source and block ID are required on the requisition form.
A pathology report must be submitted.
Whole Blood: Follow standard whole blood collection procedures. Collect 3-5 mL's whole blood in an EDTA tube. Record sample type, collection time and date onto tube and requisition form.
Bone Marrow collection, the notation of sample type, collection time and date onto the tube and requisition form is required. Ship sample at refrigerated temperature or room temperature. Ship immediately to maintain stability.
A pathology report must be submitted.
Whole Blood: Follow standard whole blood collection procedures. Collect 3-5 mL's whole blood in an EDTA tube. Record sample type, collection time and date onto tube and requisition form.
Bone Marrow collection, the notation of sample type, collection time and date onto the tube and requisition form is required. Ship sample at refrigerated temperature or room temperature. Ship immediately to maintain stability.
Transport Temperature
Room temperature
Specimen Stability
Formalin-fixed paraffin embedded tissue and Unstained slides
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
Whole blood and bone marrow aspirate
Room temperature: 72 hours
Refrigerated: 72 hours
Frozen: Unacceptable
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
Whole blood and bone marrow aspirate
Room temperature: 72 hours
Refrigerated: 72 hours
Frozen: Unacceptable
Methodology
Next Generation Sequencing
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Set up: Tues-Sat; Report available: 4-5 days
Reference Range
| HRAS Mutation, Cell-based | Not detected |
| KRAS Mutation, Cell-based | Not detected |
| NRAS Mutation, Cell-based | Not detected |
Clinical Significance
Activating RAS mutations can be found in human malignancies with an overall frequency of 15-20%. A high incidence of RAS gene mutations has been reported in malignant tumors of the pancreas (80-90%, KRAS), in colorectal carcinomas (30-60%, KRAS), in non-melanoma skin cancer (30-50%, HRAS), in hematopoietic neoplasia of myeloid origin (18-30%, KRAS or NRAS). The presence of KRAS mutation in most tumor types is associated with adverse prognosis as well as resistance to receptor tyrosine kinase-directed targeted therapies, including against EGFR. The presence of a KRAS G12C mutation has been shown to be associated with response to targeted therapy with KRAS G12C inhibitors. KRAS, along with others, is an emerging biomarkers in NSCLC (non-small cell lung cancer) and other tumor types. Currently, in NSCLC the KRAS G12C mutation is prevalent in approximately 13% of patients and represents nearly half (44%) of all KRAS mutations. Investigational agents targeting KRAS G12C are currently in clinical trials.
Performing Laboratory
| Quest Diagnostics Nichols Institute-San Juan Capistrano, CA |
| 33608 Ortega Highway |
| San Juan Capistrano, CA 92675-2042 |
