Screening panel detects EGFR and KRAS mutations (pyrosequencing), ALK and ROS1 fusion proteins (IHC).
Polymerase Chain Reaction/Pyrosequencing/Immunohistochemistry
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.
Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable
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.
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.
88381; 81275; 81276; 81235; 88342; 88341; if reflexed, add 88366
|Component Test Code*||Component Chart Name||LOINC|
|0040249||KRAS Mutation Detection||21702-6|
|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|