AML MRD Assay by Multiparametric Flow Cytometry

Test Code

14250

CPT Codes
88184, 88185 (x20), 88189<br>This test is not available for New York patient testing.<br>Restricted Client Code

Preferred Specimen

2 mL bone marrow in EDTA or Sodium heparin

Minimum Volume

1 mL

Other Acceptable Specimens

2-4 mL peripheral blood in EDTA or Sodium heparin

Instructions

Provide previous flow cytometry report describing LAIP.

Transport Temperature

Room temperature

Specimen Stability

Room temperature: 72 hours
Refrigerated: 72 hours
Frozen: Not acceptable

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Fixed or frozen samples

Methodology
Multiparametric Flow Cytometry

FDA Status
This test was developed using analyte specific reagents. Its performance characteristics were determined by LabPMM in a manner consistent with CLIA requirements, and is used for clinical purposes. It has not been cleared or approved by the U.S. Food and Drug Administration. Some hematopoietic neoplasms do not show immunophenotypic abnormalities, and may not be detected by flow cytometry. Flow results cannot be used alone to diagnose malignancy. Correlation with clinical, morphology and other ancillary data is recommended for complete evaluation.

Setup Schedule

Set up: Varies; Report available: 2-3 days

Reference Range

0.01%-0.1%

Clinical Significance

• Monitor and evaluate for disease relapse and recurrence
• Enroll and monitor subjects in clinical trials
• Identify tumor-specific markers for post-treatment monitoring

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.