BRAF Mutation Analysis

BRAF Mutation Analysis

Test Code

16767
81210
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
16767
81210
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
Not offered in Quest Diagnostics Nichols Institute (IFD) – San Juan Capistrano. Please provide SERVICE AREA INFORMATION to find available tests you can order.
In-home collection may be available in your area for purchase through Quest Mobile.

Clinical Significance

BRAF Mutation Analysis - BRAF encodes a serine/threonine protein kinase downstream of the epidermal growth factor receptor (EGFR) and the RAS family of small G-proteins (KRAS, HRAS and NRAS) in the MAPK pathway. BRAF is mutated in a variety of human tumors, most frequently in melanoma and in papillary thyroid cancer. BRAF mutations are also found in lower frequency in colorectal cancer, non-small cell lung cancer (NSCLC), acute myeloid leukemia (AML), hairy cell leukemia, glioma, sarcomas, breast cancer, hepatoma and ovarian cancer.

BRAF mutations are found clustered within the P-loop (exons 11&12) and activation ...

Test Resources

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Test Details

Methodology

Next Generation Sequencing

Assay Category

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.

Reference Range(s)

Not detected

Alternative Name(s)

BRAF Mutation Analysis,B-RAF

LOINC® Codes, Performing Laboratory

Service Area must be determined

Methodology

Next Generation Sequencing
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.

Reference Range(s)

Not detected

Alternative Name(s)

BRAF Mutation Analysis,B-RAF
Service Area must be determined

Preferred Specimen(s)

Formalin-fixed, paraffin-embedded tissue

Alternative Specimen(s)

5 mL whole blood or 3 mL bone marrow aspirate collected in an EDTA (lavender-top) tube or sodium heparin (green-top) tube • 8 unstained charged (+) slides

Minimum Volume

3 mL whole blood • 1 mL bone marrow aspirate • 4 unstained charged (+) slides

Collection Instructions

Do not reject specimens, send to laboratory for screening.

For submission of paraffin block, tissue source and block ID are required on the requisition form. A pathology report must be submitted.

For whole blood in EDTA specimens, sample type, collection time and date should be entered on tube and requisition form. Ship samples immediately to maintain stability. Ship samples room temperature or on ice pack in summer.

Transport Container

Formalin-fixed, paraffin-embedded tissue block

Transport Temperature

Room temperature

Specimen Stability

  • Specimen viability decreases during transit. Send specimen to testing lab for viability determination. Do not freeze. Do not reject.

Reject Criteria

Received frozen

Setup Schedule

Service Area must be determined

Formalin-fixed, paraffin-embedded tissue

5 mL whole blood or 3 mL bone marrow aspirate collected in an EDTA (lavender-top) tube or sodium heparin (green-top) tube • 8 unstained charged (+) slides

3 mL whole blood • 1 mL bone marrow aspirate • 4 unstained charged (+) slides
Do not reject specimens, send to laboratory for screening.

For submission of paraffin block, tissue source and block ID are required on the requisition form. A pathology report must be submitted.

For whole blood in EDTA specimens, sample type, collection time and date should be entered on tube and requisition form. Ship samples immediately to maintain stability. Ship samples room temperature or on ice pack in summer.
Formalin-fixed, paraffin-embedded tissue block
Room temperature
Specimen viability decreases during transit. Send specimen to testing lab for viability determination. Do not freeze. Do not reject.
Received frozen
Service Area must be determined
Not offered in Quest Diagnostics Nichols Institute (IFD) – San Juan Capistrano. Please provide SERVICE AREA INFORMATION to find available tests you can order.
In-home collection may be available in your area for purchase through Quest Mobile.
Test Details

Clinical Significance

Test Resources

Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.

The CPT codes provided are based on AMA guidance and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

This material contains content from LOINC® (http://loinc.org). The LOINC Table, LOINC Table Core are copyright © 1995-2019, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license.

The tests listed by specialty and category are a select group of tests offered. For a complete list of Quest Diagnostics tests, please adjust the filter options chosen, or refer to our Directory of Services.

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