Ordering Recommendation

Screening panel detects EGFR and KRAS mutations (pyrosequencing), ALK and ROS1 fusion proteins (IHC).

Mnemonic
LUNG PLUS
Methodology

Polymerase Chain Reaction/Pyrosequencing/Immunohistochemistry

Performed

Varies

Reported

7-14 days

New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation
Collect

Tumor tissue.

Specimen Preparation

Formalin fix (10 percent neutral buffered formalin) and paraffin embed tissue. Protect from excessive heat. Transport tissue block or 13 unstained 5- micron slides (8 on positively charged slides AND 5 on uncharged slides). (Min: 9 slides: 5 positively charged AND 4 uncharged). Tissue block will be returned after testing. Transport block and/or slide(s) in a tissue transport kit (ARUP supply #47808) available online through eSupply using ARUP Connect or contact ARUP Client Services at (800) 522-2787

Storage/Transport Temperature

Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months.

Unacceptable Conditions

Less than 25 percent tumor. Specimens fixed/processed in alternative fixatives (alcohol, Prefer®) or heavy metal fixatives. Decalcified specimens.

Remarks

Include surgical pathology report.

Stability

Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable

Reference Interval
Interpretive Data

Refer to report.

Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

Note

Panel consists of KRAS Mutation Detection by Pyrosequencing, EGFR Mutation Detection by Pyrosequencing, ALK (D5F3) with Interpretation by Immunohistochemistry, and ROS1 with Interpretation by Immunohistochemistry with Reflex to FISH if Equivocal. If reflexed, additional charges apply.

Hotline History
N/A
CPT Codes

88381; 81275; 81276; 81235; 88342; 88341; if reflexed, add 88366

Components
Component Test Code* Component Chart Name LOINC
0040249 KRAS Mutation Detection 21702-6
2002148 Block ID 57723-9
2002442 EGFR by Pyrosequencing 21665-5
2007325 ALK(D5F3) by IHC Reference Number 57723-9
2007327 ALK(D5F3) by IHC Result 35474-6
2008415 ROS1 by IHC Result
2008417 ROS1 Client Block ID
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
Lung Cancer Panel with KRAS