FusionSEQ Panel

Test Code

12353

CPT Codes
81445<br><strong>This test is not available for New York or Rhode Island patient testing.</strong>

Includes

FusionSEQ
ALK RNA Rearrangement
EGFR RNA Rearrangement
FGFR1 RNA Rearrangement
FGFR2 RNA Rearrangement
FGFR3 RNA Rearrangement
MET RNA Rearrangement
NRG1 RNA Rearrangement
NTRK1 RNA Rearrangement
NTRK2 RNA Rearrangement
NTRK3 RNA Rearrangement
RET RNA Rearrangement
ROS1 RNA Rearrangement
EGFR Skipping
MET Skipping

Preferred Specimen

6-10 slides (10-micron sections) for resection or surgical specimens with H&E slide in slide holder, or 10-20 slides (10-micron sections) for core needle biopsies

Other Acceptable Specimens

Paraffin-embedded tissue block accompanied by a circled H&E slide indicating the area to be examined

Instructions

Do not freeze. Do not reject. Submit in sterile biohazard plastic bag at room temperature or on ice pack in summer. Specimen to be tested should contain a minimum of 10 percent tumor nuclei.
All specimens must be accompanied with Pathology report. All FFPE specimens will be examined by a pathologist for confirmation and adequacy. Macrodissection if warranted is performed in the lab.

Transport Container

Sterile biohazard plastic bag

Transport Temperature

Room temperature or refrigerated (cold packs)

Specimen Stability

Room temperature: Preferred
Refrigerated: Acceptable
Frozen: Unacceptable

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

Decalcified tissue specimen

Methodology
Anchored Multiplex Polymerase Chain Reaction • 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

Set up: Daily; Report available: 11-15 days

Reference Range

See Laboratory Report

Clinical Significance

The FusionSEQ assay detects the presence of known and novel gene rearrangements (fusions) and exon skipping events in clinically relevant genes associated with the pathogenesis of many pediatric and adult solid tumors malignancies. FDA approved therapies and clinical trials are available for patients with these genomic abnormalities in certain solid tumors, and the detection of these abnormalities is beneficial in the management of disease and survival of the patient.

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.