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Test Code ALKLC Anaplastic Lymphoma Kinase for Lung Cancer, Immunohistochemistry


Shipping Instructions


Attach the green "Attention Pathology" address label (T498) included in the kit to the outside of the transport container.



Necessary Information


A pathology/diagnostic report and a brief history, including primary site of neoplasm, are required.



Specimen Required


Supplies: Pathology Packaging Kit (T554)

Specimen Type: Formalin-fixed, paraffin-embedded tissue block; or 3 unstained glass, “positively charged" slides with 4-microns, formalin-fixed, paraffin-embedded tissue

Additional Information: One slide will be stained with hematoxylin and eosin and returned.


Useful For

Identification of anaplastic lymphoma kinase (ALK) expression

 

Prediction of tumor response to targeted therapy of non-small cell lung carcinomas.

Method Name

Immunohistochemistry (IHC)

Reporting Name

ALK for Lung Cancer IHC

Specimen Type

Special

Specimen Stability Information

Specimen Type Temperature Time
Special Ambient (preferred)
  Refrigerated 

Reject Due To

Wet/frozen tissue Reject
Cytology smears Reject
Nonformalin fixed tissue Reject
Nonparaffin embedded tissue Reject
Noncharged slides Reject
ProbeOn slides Reject

Clinical Information

A subset of lung cancers, specifically adenocarcinomas, harbor anaplastic lymphoma kinase (ALK) rearrangements. Expression of ALK in tumor cells can be used as a surrogate marker for ALK rearrangement. The presence of ALK rearrangement (ALK protein expression) is a predictive biomarker for response to ALK tyrosine kinase inhibitors.

Interpretation

This test, when not accompanied by a pathology consultation request, will be answered as either positive or negative. If additional interpretation or analysis is needed, request PATHC / Pathology Consultation along with this test.

Cautions

Age of a cut paraffin section can affect immunoreactivity. Stability thresholds vary widely among published literature and are antigen dependent. Best practice is for paraffin sections to be cut within 6 weeks.

 

The charge of glass slides can be affected by environmental factors and subsequently may alter slide staining. Sending unsuitable glass slides can result in inconsistent staining due to poor slide surface chemistry.

 

Best practices for storage of positively charged slides:

-Minimize time slides are stored after being unpackaged

-Limit exposure to high humidity and heat

-Minimize exposure to plastics

Method Description

Immunohistochemistry on sections of paraffin-embedded tissue.(Unpublished Mayo method)

Day(s) Performed

Monday through Friday

Report Available

5 to 7 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

88342-Primary

88341-If additional IHC

LOINC Code Information

Test ID Test Order Name Order LOINC Value
ALKLC ALK for Lung Cancer IHC 47303-3

 

Result ID Test Result Name Result LOINC Value
615714 Interpretation 59465-5
615715 Participated in the Interpretation No LOINC Needed
615716 Report electronically signed by 19139-5
615717 Material Received 81178-6
615718 Disclaimer 62364-5
615719 Case Number 80398-1

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
IHPCA IHC Additional No No
IHPCI IHC Initial No No

Testing Algorithm

For the initial immunohistochemistry (IHC) stain performed, the appropriate bill-only test ID will be added and charged (IHPCI). For each additional IHC stain performed, an additional bill-only test ID will be added and charged (IHPCA).