MELANOMASEQPlus

Test Code

36912

CPT Codes
81445<br>**This test is not available for New York patient testing.**

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

Other Acceptable Specimens

4-6 aspirates (18 gauge needed preferred) Core needle biopsy • Fine needle aspirate • Malignant fluid in formalin-fixed paraffin-embedded block

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

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

Tuesday Morning
Report available: 8 Days

Reference Range

See Laboratory Report

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.

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.