Lung Cancer (NSCLC), ROS1 (6q22) Rearrangement, FISH

Test Code

91836

CPT Codes
88271 (x2), 88274

Preferred Specimen

Formalin-fixed, paraffin-embedded tissue block

Other Acceptable Specimens

5x5 mm tumor tissue in culture transport medium • 4-5 microns sections on charged slide (x5)

Instructions

Lung tissue biopsy, formalin fixed paraffin-embedded block or charged/+slides from formalin fixed paraffin embedded tissue. Specimen MUST be fixed with 10% neutral buffered formalin. Fixation between 6 and 48 hours is recommended. Pathology report must accompany paraffin block or slides.
Information required in this report includes: Physician identification, specimen identifiers (case and block number), specimen site and type, tissue processing used (routine or microwave), type of fixative, time and duration of fixation, pathologic diagnosis.

Transport Temperature

Room temperature

Specimen Stability

Specimen viability decreases during transit. Send specimen to testing lab for viability determination. Do not freeze. Do not reject.

Methodology
Fluorescence in situ Hybridization (FISH)

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

Set up: Daily; Report Available: 7 days

Clinical Significance

ROS1 rearrangement has been identified in 1.7% of non small-cell lung cancer (NSCLC) by using a FISH assay. Treatment with ALK/MET tyrosine kinase inhibitors such as crizotinib (Xalkori(R)) has shown early evidence of therapeutic efficacy in ROS1-rearranged NSCLC (Bergethon, et al. J Clin Oncol. 2012;30:863-870)

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.