LiquidSEQ™

Test Code

14308

CPT Codes
81464<br><strong>This test is not available for New York and Wyoming patient testing.</strong>

Preferred Specimen

10 mL whole blood collected in each of two separate Streck cell-free DNA blood collection tubes

Minimum Volume

10 mL

Instructions

This test requires two Streck tubes. Blood will be collected in office via Quest-LiquidSEQ Gen Kit. Specimens may be shipped separately and at different times. Do not hold blood specimen due to short stability. Do not reject.

Blood collection using a straight needle is preferred. Use kit only. All tubes must be filled completely. Gently invert tube at least 8 times immediately after draw.

Transport Temperature

Room temperature

Specimen Stability

Room temperature: 7 days
Refrigerated: Unacceptable
Frozen: Unacceptable

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

Do not reject, send to laboratory for testing assessment

Methodology
Next Generation Sequencing (NGS)

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, Tues, Thurs; Report available: 7-10 days

Reference Range

See Laboratory Report

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 blood. This comprehensive panel offers the opportunity for a broader scope of genomic information compared to single gene tests or smaller panels and an alternative specimen type for comprehensive genomic profiling of a patient s solid tumor. For example, it may be useful for patients with limited or ill-defined treatment options and for those considering clinical trials in the event tumor tissue is not available or insufficient for tissue-based testing. This panel uses next-generation sequencing to detect mutations present in circulating tumor DNA (ctDNA) extracted from a solid tumor patient's blood plasma. The test is designed to detect single nucleotide variants (SNVs) and small insertions/deletions, as well as whole-gene copy number alterations and translocations 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.