IDH1 (R132) and IDH2 (R140 and R172) Quantitative Detection, Droplet Digital PCR, Varies

Casandra

Casandra Test Code MC54009Version 1 (DRAFT)

Performing Lab

Lab Mayo Clinic LabLab Test ID IDHQCPT Codes 81120, 81121

IDH1 (R132) and IDH2 (R140 and R172) Quantitative Detection, Droplet Digital PCR, Varies

Clinical Use

Use

This test is useful for detecting IDH1 R132 and IDH2 R140 and R172 mutations in patients with acute myeloid leukemia (AML) at the time of diagnosis to guide targeted therapy. It can also be used for monitoring minimal residual disease during the clinical and therapeutic course. This highly sensitive quantitative assay detects 6 mutations in IDH1 and 10 mutations in IDH2, providing crucial information for the treatment of AML.

Special Instructions

Refrigerated specimens must arrive within 14 days of collection, while ambient specimens must arrive within 7 days. Label specimens accurately, indicating the source (blood or bone marrow), and include pertinent clinical history and date of collection with the sample.

Limitations

The assay does not detect IDH1 or IDH2 variants outside of the 16 specific mutations targeted. It is not FDA approved but developed according to CLIA requirements. Interassay variability may occur, and result changes should not be considered significant if they differ by less than 0.5 log (3.16-folds). The test may not be suitable for identifying de novo mutations outside the provided mutation list.

Test Details

New York Approved