Screening panel detects EGFR mutations (pyrosequencing), ALK and ROS1 fusion proteins (IHC).
Polymerase Chain Reaction/Pyrosequencing/Immunohistochemistry
New York DOH Approval Status
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.
Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months.
Less than 25 percent tumor. Specimens fixed/processed in alternative fixatives (alcohol, Prefer) or heavy metal fixatives. Decalcified specimens.
Include surgical pathology report.
If multiple specimens (blocks or slides) are sent to ARUP, they must be accompanied by one of the following: an order comment indicating that the ARUP pathologist should choose the specimen most appropriate for testing (e.g., "Choose best block"), or individual orders for each sample submitted. A Pathologist Block Selection Fee (ARUP test code 3002076) will be added to orders that utilize the first option. If multiple specimens are sent to ARUP without a request for pathologist block/slide selection or individual orders, they will be held until clarification is provided.
Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable
Refer to report.
This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.
Laboratory Developed Test (LDT)
Panel consists of 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.
88381; 81235; 88342; 88341; if reflexed, add 88366
|Component Test Code*||Component Chart Name||LOINC|
|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|