FISH, Chromosome +9/Deletion 9p21, TC

Test Code

12630

CPT Codes
88271 (x2), 88275<br>Restricted Client Code - Tech Only

Preferred Specimen

3 mL bone marrow or 5 mL whole blood collected in sodium heparin (green-top) tube

Minimum Volume

1 mL bone marrow • 3 mL whole blood

Other Acceptable Specimens

Bone marrow or whole blood collected in: sodium heparin (royal blue-top) tube, or sodium heparin, lead-free (tan-top) tube • Bone marrow submitted in culture transport media

Instructions

Clinical history and reason for referral are required with test order. Prior therapy and transplant history should be provided with test order.

Submit 1 to 3 mL of bone marrow or 3 to 5 mL whole blood in a sodium heparin (green-top) tube. Bone marrow culture transport medium available upon request.

Specimen viability decreases during transit. Send specimen to testing lab for viability determination. Do not freeze. Do not reject.

Transport Temperature

Room temperature

Specimen Stability

See Instructions

Methodology
Fluorescence in situ Hybridization

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: 5 days

Clinical Significance

100-300 interphase cells are microscopically scored for the number of probe signals to determine the copy number for 9p21 and centromere 9. Deletions of 9p21 region are found mainly in acute lymphoblastic leukemia (ALL), occurring in approximately 10% of both pediatric and adult cases. The deletion is an adverse risk factor for B-lineage ALL, but not for T-lineage. Trisomy 9 and additional copies of 9p due to unbalanced chromosome rearrangements are recurrent abnormalities in chronic myeloproliferative disorders (MPD), including polycythemia vera, essential thrombocythemia, and myelofibrosis.

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.