MELANOMASEQPlus
Test code
CPT code(s)*
Test resources
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Details
Includes
BRAF, CTNNB1, BNA11, GNAQ, GNAS, HRAS, KIT, KRAS, NRAS, PIK3CA, PTEN
Methodology
Next Generation Sequencing
Assay category
This test was developed and its performance characteristics determined by med fusion. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity clinical laboratory testing.
This test is not available for New York patient testing.
Specimen requirements | |
|---|---|
| Patient preparation | None Specified |
| Preferred specimen(s) | Paraffin-embedded tissue collected in a formalin-fixed paraffin-embedded block or Core needle biopsy (4-6 aspirates, 18 gauge needle preferred) or Fine needle aspirate or Malignant fluid in formalin-fixed paraffin-embedded block |
| Alternative specimen(s) | 10 formalin-fixed paraffin-embedded unstained, positively charged, unbaked 5 micron sections in slide holder |
| Collection instructions | Specimen to be tested must contain a minimum of 20% tumor |
| Transport container | Formalin-fixed paraffin-embedded tissue block |
| Transport temperature | Room temperature |
| Specimen stability | Room temperature: Indefinitely Refrigerated: Indefinitely Frozen: Unacceptable |
| Reject criteria | Decalcified tissue specimen |
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.
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