Chromosomal Microarray, Solid Tumor FFPE, Clarisure® Oligo-SNP

Test Code

38842

CPT Codes
81277

Preferred Specimen

5x5 mm tissue in formalin-fixed, paraffin-embedded block

Minimum Volume

2x3 mm tissue block

Other Acceptable Specimens

5 unstained (4-6 micron sections), positively charged slides

Instructions

Formalin-fixed, paraffin-embedded tissue or charged/+slides from formalin fixed, paraffin embedded tissue. Specimen MUST be fixed in 10% neutral buffered formalin. Cold ischemic time of less than 1 hour and fixation between 6 and 72 hours is recommended.

Pathology report must be supplied with sample. Ship at room temperature. Do not freeze.

Send specimen to testing lab for viability determination. Do not reject.

Transport Temperature

Room temperature

Specimen Stability

Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable

Methodology
Oligo-SNP Array

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

Set up: Daily; Report available: 15 days

Reference Range

Interpretive report

Clinical Significance

To integrate the microarray in the investigation of neoplasms to assess genomic alterations and overall genomic complexity of the abnormal clone. To be used in conjunction with other established clinical laboratory tests for the malignancy in question.

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.