CBFB::MYH11 Inversion(16), Quantitative Detection and Minimal Disease Risk Monitoring, qRT-PCR, Varies

Casandra

Casandra Test Code MC51636Version 1 (DRAFT)

Performing Lab

Lab Mayo Clinic LabLab Test ID IN16QCPT Code 81401

CBFB::MYH11 Inversion(16), Quantitative Detection and Minimal Disease Risk Monitoring, qRT-PCR, Varies

Clinical Use

Use

This test detects the CBFB::MYH11 gene fusion in patients with acute myeloid leukemia (AML) and provides minimal residual disease monitoring during the clinical and therapeutic course. It is useful at the time of diagnosis and for post-therapy monitoring, aiding in evaluating disease response and identifying relapse risk.

Special Instructions

Refrigerated specimens must arrive within 5 days of collection, and ambient specimens within 3 days. Collect and package specimen as close to shipping time as possible. The following information is required: pertinent clinical history, date of collection, and specimen source (blood or bone marrow).

Limitations

This assay will only detect the 3 major exon fusions of CBFB::MYH11, accounting for ≥95% of cases and will not detect rare fusion types (<5%). Gross hemolysis and inappropriate handling may lead to sample rejection. Interassay variability means result changes should not be considered significant if 2 measurements differ by less than 0.5 log unless accompanied by a change in positivity status or ≥1 log increase.

Test Details

New York Approved