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 in formalin fixed, paraffin embedded block


Other Acceptable Specimens
4-6 micron unstained sections (x5)


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 Container
Formalin-fixed, paraffin-embedded tissue block


Transport Temperature
Room temperature


Specimen Stability
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Not established


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 FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
Daily


Report Available
15 days


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.


Performing Laboratory
Quest Diagnostics Nichols Institute-San Juan Capistrano, CA
33608 Ortega Highway
San Juan Capistrano, CA 92675-2042



Last Updated: November 6, 2024


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.