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 # |
MELANOMASEQPlus
Test Code36912
CPT Codes
81445<br><strong>This test is not available for New York patient testing.</strong>
Includes
BRAF, CTNNB1, BNA11, GNAQ, GNAS, HRAS, KIT, KRAS, NRAS, PIK3CA, PTEN
Preferred Specimen
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
Core needle biopsy (4-6 aspirates, 18 gauge needle preferred) or
Fine needle aspirate or
Malignant fluid in formalin-fixed paraffin-embedded block
Other Acceptable Specimens
10 formalin-fixed paraffin-embedded unstained, positively charged, unbaked 5 micron sections in slide holder
Instructions
Specimen to be tested must contain a minimum of 20% tumor
Transport Temperature
Room temperature
Specimen Stability
Room temperature: Indefinitely
Refrigerated: Indefinitely
Frozen: Unacceptable
Refrigerated: Indefinitely
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Decalcified tissue specimen
Methodology
Next Generation Sequencing
FDA Status
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.
Setup Schedule
Sets up 1 day a week.
Clinical Significance
Disease-specific solid tumor panel intended to aid the oncologist in prioritizing standard of care therapy and clinical trial choices for patients with advanced stage melanoma.