FISH, ATM and TP53

Test Code

13574

CPT Codes
88271 (x2), 88275

Includes

If results are not possible from the submitted specimen, the test order will be cancelled and replaced by non-orderable test Cytogenetics Communication.

Preferred Specimen

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

Minimum Volume

3 mL whole blood • 1 mL bone marrow

Other Acceptable Specimens

Whole blood or bone marrow collected in: sodium heparin (dark blue-top) tube, sodium heparin lead-free (tan-top) tube, or EDTA (lavender-top) tube

Instructions

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

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

Transport Temperature

Room temperature

Specimen Stability

Room temperature: Preferred
Refrigerated: Acceptable
Frozen: Unacceptable

Methodology
Fluorescence in situ Hybridization (FISH)

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

Set up: Daily; Report available: 5 days

Reference Range

See Laboratory Report

Clinical Significance

The most common prognostically established cytogenetic abnormalities in CLL/SLL are 13q14 deletion, +12, TP53 (17p) deletion and ATM (11q) deletion. Although all these aberrations can be detected using the CLL/SLL FISH panel, the ATM and TP53 deletions status can be ordered separately. TP53 (17p) deletion predicts treatment failure with alkylating agents, fludarabine and short survival times. Patients with TP53 deletions should be treated with targeted therapy. ATM (11q) deletion is associated with marked lymphadenopathy, rapid disease progression, and unfavorable prognosis. In multivariate analysis, TP53 and ATM deletions provided independent prognostic information. In addition to CLL/SLL, ATM and TP53 deletions can also be seen in other B-cell lymphoproliferative disorders.

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.