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Anaplastic Lymphoma Kinase (ALK), D5F3, CDx, IHC

CPT Call client services.
Synonyms
  • ALK (D5F3), IHC

Test Details

Cancer Type

Hematologic malignancies, Lung, Non-small cell lung cancer

Technology Used

IHC

Turnaround Time

2 - 5 days

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Use

Detection of anaplastic lymphoma kinase (ALK) in FFPE non−small-cell lung carcinoma. The assay is indicated as an aid in identifying NSCLC patients eligible for treatment with crizotinib (Xalkori®), ZYKADIA® (ceritinib), LORBRENA® (lorlatinib) or ALECENSA® (alectinib).

Special Instructions

Pertinent clinical diagnosis, including pathology report documenting pulmonary origin, should be included with the specimen.

Methodology

Immunohistochemistry (IHC)

Specimen Requirements

Information on collection, storage, and volume

Specimen

Tissue

Volume

One formalin-fixed, paraffin-embedded (FFPE) tissue block or five unstained positively charged slides sectioned from FFPE tissue block at 4 to 5 microns

Minimum Volume

Three unstained tissue slides

Storage Instructions

Room temperature

Causes for Rejection

Insufficient tissue; inappropriate tissue source; incorrect specimen type; decalcified specimens

Collection

Tissue should be fixed in 10% neutral buffered formalin a minimum of six hours and no more than 72 hours. Embed in paraffin.

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