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ALK (D5F3) CDx IHC

Department

Advanced Diagnostics

Specimen Collection Criteria

Collect (preferred specimen):  Formalin-fixed, paraffin-embedded (FFPE) block with corresponding H&E slide. Tissue should be well fixed and processed. Tissue should not be decalcified. Please provide a pathology report with each specimen, including type of fixative and hours duration of fixation (if known). Tissue must be fixed for a minimum of 6 hours in 10% neutral buffered formalin. Indicate fixation time on test requisition.

Also acceptable: One H&E slide plus 3 unstained tissue sections cut at 4.0 um thick and placed on charge slides. Air dry, do not oven dry. Tissue adherence cannot be guaranteed for sections placed on plain glass slides. Send all slides within 6 weeks of cutting.

Specimen must be accompanied by a completed requisition and must contain the patient name, date of birth, collection date, ordering physician, source of specimen, and fixation time, if known. Please provide a pathology report with each specimen.

Alternative (suboptimal specimen): If non-decalcified FFPE is not available, ALK IHC testing may be attempted on tissue that has been decalcified or on cytology cell block sections; however, ALK IHC testing is not FDA-approved for decalcified tissue or cytology cell blocks. It will be stated in the report that ALK IHC testing on these alternative specimens is not recommended, not validated, and not FDA-approved.

Physician Office/Draw Specimen Preparation

Maintain paraffin-embedded tissue or slides at room temperature (20-26ºC or 68-78.8ºF) until transport.

Preparation for Courier Transport

Transport:  Paraffin-embedded tissue or slides at room temperature (20-26ºC or 68-78.8ºF).

Rejection Criteria

Tissue in fixatives other than 10% neutral buffered formalin. (See above regarding decalcified FFPE tissue and cytology cell blocks)

Improper labeling, inadequate information.

Inpatient Specimen Preparation

In-house specimens are picked up by a Surgical Pathology assistant every hour on the hour.

In-Lab Processing

Maintain specimens at room temperature (20-26ºC or 68-78.8ºF) until testing.

Storage

Specimen Stability for Testing:

Paraffin-Embedded Tissue
Room Temperature (20-26ºC or 68-78.8ºF): Indefinitely
Refrigerated (2-8ºC or 36-46ºF): Unacceptable
Frozen (-20ºC/-4ºF or below): Unacceptable                                                                                 
Tissue Section on Glass Slide
Room Temperature (20-26ºC or 68-78.8ºF): 6 weeks
Refrigerated (2-8ºC or 36-46ºF): Unacceptable
Frozen (-20ºC/-4ºF or below): Unacceptable 

Decalcified FFPE tissue blocks or cytologic cell blocks
Room Temperature (20-26ºC or 68-78.8ºF): Indefinitely
Refrigerated (2-8ºC or 36-46ºF): Unacceptable
Frozen (-20ºC/-4ºF or below): Unacceptable 

Specimen Storage in Department Prior to Disposal

Room Temperature (20-26ºC or 68-78.8ºF): 7 days

Laboratory

Royal Oak Anatomic Pathology – Advanced Diagnostics Laboratory.

Performed

Twice weekly.
Results available in 7 business days.

Reference Range

Scoring Guidelines:

Clinical Interpretation	Staining Description
Positive for ALK	Presence of strong granular cytoplasmic staining in viable tumor cells (any percentage of positive tumor cells). Certain staining elements in cells other than viable neoplastic cells will be excluded according to the manufacturer’s instructions.1
Negative for ALK	Absence of strong granular cytoplasmic staining in viable tumor cells.

Test Methodology

Ventana ALK (D5F3) CDx Assay is a rabbit monoclonal primary antibody that binds to ALK in paraffin-embedded tissue sections. The specific antibody can be visualized using OptiView DAB IHC Detection Kit followed by the OptiView Amplification Kit.

Interpretation

The clinical interpretation of any staining, or the absence of staining, must be complemented by histological studies and evaluation of proper controls.  Evaluation must be made by a qualified pathologist within the context of the patient’s clinical history and other diagnostic tests.¹

Clinical Utility

XALKORI ® (crizotinib) is indicated for treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ALK positive as detected by a FDA-approved test.

Reference

1. Ventana ALK (D5F3) CDx Assay Interpretation Guide for Non-Small Cell Lung Carcinoma (NSCLC), Roche.

CPT Codes

88342

Contacts

Last Updated

9/29/2022