Solid TumorSEQ™

Test Code

14309

CPT Codes
0379U<br><strong>This test is not available for Wyoming patient testing</strong>

Preferred Specimen

Tissue: 1 paraffin block

Minimum Volume

1 paraffin block • 5 unstained slides

Other Acceptable Specimens

Slides: 10 unstained slides

Instructions

Ship ambient or on ice pack in summer.

For FFPE and slides a pathology report must be submitted with sample. Do not reject. Submit tissue in sterile biohazard plastic bag.

Transport Temperature

Room temperature

Specimen Stability

Room temperature: Acceptable
Refrigerated: Acceptable
Frozen: Unacceptable

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Do not reject, send to laboratory for testing assessment

Methodology
Next Generation Sequencing

FDA Status
This test was developed and its performance characteristics determined by Quest Diagnostics. 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

Set up: Sun, Tue, Thu; Report available: 7-10 days

Clinical Significance

The 523-gene comprehensive genomic profiling panel is intended to help oncologists deliver precision medicine by providing personalized genomic analysis of a patient's tumor tissue. This comprehensive panel offers the opportunity for a broader scope of genomic information compared to single gene tests or smaller panels. For example, it may be useful for patients with limited or ill-defined treatment options and for those considering clinical trials. This panel uses next-generation sequencing to detect mutations present in DNA and RNA extracted from formalin-fixed, paraffin embedded (FFPE) tissue sections of solid tumors. The test is designed to detect single nucleotide variants (SNVs) and small insertions/deletions, as well as whole-gene copy number alterations, translocations, and splice site variants in a select group of genes. Microsatellite instability (MSI) and tumor mutation burden (TMB) are also evaluated.

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.