Lung Cancer (NSCLC), ROS1 (6q22) Rearrangement, FISH
Test Summary
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)
Aliases
- N/A
Specimen Collection
Special Instructions
N/A
Preferred Specimen
Lung tissue biopsy in formalin-fixed paraffin-embedded tissue block
Minimum Volume
N/A
Instructions
Lung tissue biopsy, formalin-fixed, paraffin-embedded block or charged/+ slides from formalin fixed paraffin embedded tissue. Specimen MUST be fixed in 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 include: 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. Ship at room temperature. Do not freeze. Do not reject.
Note: Test performed: 100-300 interphase cells are microscopically analyzed for probe signal patterns indicating rearrangement of ROS1 located at 6q22.
If results are not possible, the test order may be canceled and replaced with a Cytogenetics Communication.
Pathology report must accompany paraffin block or slides. Information required in this report include: 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. Ship at room temperature. Do not freeze. Do not reject.
Note: Test performed: 100-300 interphase cells are microscopically analyzed for probe signal patterns indicating rearrangement of ROS1 located at 6q22.
If results are not possible, the test order may be canceled and replaced with a Cytogenetics Communication.
Patient Preparation
N/A
Storage
N/A
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.
Limitations
N/A
Other Acceptable Specimens
5x5 mm tumor tissue in culture transport medium • 4-5 microns sections on charged slide (x5)
Unacceptable Specimens
N/A
Order Code
LCROS1
EPIC (Premier) Code
LAB5412
Includes
N/A
CPT Code
- 88271 (x2)
- 88274
Billing Code
- 671066
- 671067
CPT Statement
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 by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Physician Attestation of Informed Consent
N/A
Testing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly VA, 20153
14225 Newbrook Drive
Chantilly VA, 20153
Reference Range
See Laboratory Report
Setup Schedule / Expected Turnaround Time
Daily; Report available: 7 days
Specimen Collection
Special Instructions
N/A
Preferred Specimen
Lung tissue biopsy in formalin-fixed paraffin-embedded tissue block
Minimum Volume
N/A
Instructions
Lung tissue biopsy, formalin-fixed, paraffin-embedded block or charged/+ slides from formalin fixed paraffin embedded tissue. Specimen MUST be fixed in 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 include: 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. Ship at room temperature. Do not freeze. Do not reject.
Note: Test performed: 100-300 interphase cells are microscopically analyzed for probe signal patterns indicating rearrangement of ROS1 located at 6q22.
If results are not possible, the test order may be canceled and replaced with a Cytogenetics Communication.
Pathology report must accompany paraffin block or slides. Information required in this report include: 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. Ship at room temperature. Do not freeze. Do not reject.
Note: Test performed: 100-300 interphase cells are microscopically analyzed for probe signal patterns indicating rearrangement of ROS1 located at 6q22.
If results are not possible, the test order may be canceled and replaced with a Cytogenetics Communication.
Patient Preparation
N/A
Storage
N/A
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.
Limitations
N/A
Other Acceptable Specimens
5x5 mm tumor tissue in culture transport medium • 4-5 microns sections on charged slide (x5)
Unacceptable Specimens
N/A
Result Information
Methodology
Fluorescence In Situ Hybridization (FISH)
Testing Laboratory
N/A
Reference Range
See Laboratory Report
Setup Schedule / Expected Turnaround Time
Daily; Report available: 7 days