BCR-ABL1 Major (p210) by Quantitative RT-PCR for Monitoring : 1016498

MDFCPBCRABLQPMA or 1016498

Philadelphia Chromosome Ph1 Bone Blood; t(9;22) p210 detection; BCR/ABL; BCR/ABL1; CML

Peripheral Blood in a lavender top tube (EDTA).

Submit 5-10 mL Blood (Min. 5 mL) : Do not centrifuge.

Refrigerated.

Ambient: 1 hour; Refrigerated: 72 hours; Frozen: Unacceptable

Samples submitted in Sodium Heparin.

Monday - Friday

2-5 days

The QuantideX qPCR BCR-ABL IS Kit has been validated for whole blood collected in EDTA tubes. It has not been validated for use with bone marrow samples. This assay is only designed to detect, but not distinguish between the BCR-ABL1 fusion transcripts e13a2 (b2a2) and e14a2 (b3a2). The ability to detect other fusion transcripts has not been fully evaluated. The test does not detect minor or micro breakpoints, microdeletions, or mutations. Low RNA quality and/or quantity can greatly affect the results of this assay, which may lead to software errors and/or misquantification. Some patients with very low levels of BCR-ABL1 transcript (above MR4.7 or below 0.002%IS) may be reported as not detected. Hence, a not detected result does not preclude the presence of low levels of leukemic cells in the patient.

An interpretive report will be provided.

This assay utilizes the FDA-cleared QuantideX qPCR BCR-ABL IS Kit, an in vitro nucleic acid amplification test for the quantitation of BCR-ABL1 and ABL1 transcripts in total RNA from whole blood of diagnosed t(9;22) positive Chronic Myeloid Leukemia (CML) patients expressing BCR-ABL1 fusion transcripts type e13a2 and/or e14a2. The QuantideX qPCR BCR-ABL IS Kit is a reverse transcription-quantitative PCR performed on the Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument and is intended to measure BCR-ABL1 to ABL1, expressed as a log molecular reduction (MR value) from a baseline of 100% on the International Scale, in t(9;22) positive CML patients during monitoring of treatment with Tyrosine Kinase Inhibitors (TKIs). The test does not differentiate between e13a2 or e14a2 fusion transcripts and does not monitor other rare fusion transcripts resulting from t(9;22). This test is not intended for the diagnosis of CML.

Recommendations for periodic BCR-ABL1 fusion transcript measurements with RT-qPCR to monitor treatment response in CML patients in comparison to particular clinical landmarks have been introduced and incorporated into recognized treatment guidelines (for example, NCCN in CML v.2.2017 or more recent version). NCCN guidelines recommend monitoring CML patients every 3 months on therapy to assist in determining response to therapy which may trigger additional patient workup to optimize or change therapy. Major molecular response (MMR), defined as 0.1% IS (MR3.0) on the International Scale, has been established as an important milestone in CML treatment. Reaching MMR after 12 or 18 months of imatinib treatment or 12 months for second generation TKI is associated with better progression-free survival and overall survival.