LungSEQ Concurrent Panel, without PD-L1

Test Code

12184

CPT Codes
81445, 88377 (x4)

Includes

ALK Variant,
AKT1 Variant
BRAF Variant
EGFR Variant
ERBB2 (HER2) Variant
KRAS Variant
MAP2K1 (MEK1) Variant
NRAS Variant
PIK3CA (PI3K) Variant
PTEN Variant
ALK Rearrangement
RET Rearrangement
ROS1 Rearrangement
MET Amplification

Preferred Specimen

Paraffin-embedded tissue accompanied by a circled H&E slide indicating the area to be examined collected in a sterile biohazard plastic bag or
19 formalin-fixed paraffin-embedded tissue slides and H&E slide collected in a slide holder

Other Acceptable Specimens

Paraffin-embedded tissue block or slides

Instructions

Submit paraffin embedded tissue block accompanied by a circled H&E slide indicating the area to be examined:
submit in sterile biohazard plastic bag at ambient temperature or on ice pack in summer.
Slides: submit 19 unstained slides and H&E slide in slide holder at ambient temperature.
Do not freeze. Do not reject.
Please submit Path report for FFPE and Slides. Specimen to be tested should contain a minimum of 10 percent tumor nuclei. Decalcified specimens are not acceptable.
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 Temperature

Room temperature

Specimen Stability

Room temperature: Preferred
Refrigerated: Acceptable
Frozen: Unacceptable

Methodology
Next Generation Sequencing • Fluorescence in situ Hybridization (FISH)

FDA Status
This test was developed and its performance characteristics determined by MedFusion. 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 2 days a week.

Clinical Significance

This test is intended to be used for the mutational profiling of tumors from patients with Non-Small-Cell Lung Cancer in order to help prioritize and direct treatment. It may be useful for patients who have become refractory to prior therapies and are searching for investigational targeted therapies offered in clinical trials or for newly diagnosed patients who would like to know their mutational profile to inform treatment options with approved targeted therapies or for the identification of potential future clinical trials or future approvals of targeted therapies.

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.