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| BCR/ABL Test Information |
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| (1) Who performs BCR-ABL measurements? |
Many labs perform BCR-ABL quantitation. As a CML ALLIANCE™ partner, MolecularMD has undergone a rigorous evaluation process and is one of only two laboratories Novartis has validated to perform QRT-PCR BCR-ABL testing.
MolecularMD is the only commercial laboratory to offer QRT-PCR BCR-ABL testing with international reference standards defining MMR, thanks to an exclusive agreement with the lead investigators of the International Randomized Interferon versus STI571 (IRIS) study. To ensure the reliability and reproducibility of every assay, every sample is run against the standards including MMR, for the most accurate BCR-ABL quantification available today.
In addition, MolecularMD has optimized the assay for rapid turn-around time, reproducibility and enhanced sensitivity. The MolecularMD BCR-ABL assay offers unparalleled sensitivity and reproducibly, reliably detecting down to three copies of BCR-ABL in patients at MRD, a level at least 1 to 1.5 logs below MMR.
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| (2) How much does it cost to measure BCR-ABL levels? |
| MolecularMD is offering a special introductory price for the QRT-PCR BCR-ABL test for all CML ALLIANCE patients. Please call MolecularMD Customer Service (888-663-7382) for more information or see the Billing and Reimbursment section of the FAQ's for more information. |
| (3) How does MolecularMD measure BCR-ABL levels? |
BCR-ABL RNA is extracted from a blood or bone marrow sample and is measured using QRT-PCR.
To reliably and reproducibly detect BCR-ABL levels at MMR, the assay needs to have a sensitivity well below MMR. MolecularMD’s assay meets this performance criterion, reliably detecting BCR-ABL levels down to 1.5 logs below MMR (4.5 logs below baseline).
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| (4) Can BCR-ABL quantitation be used to diagnose CML? |
The National Comprehensive Cancer Network (NCCN) guidelines do not include BCR-ABL quantitation as a tool for diagnosis. However, it is important to get a baseline measurement at the time of diagnosis and before treatment so that therapy efficacy can be monitored over time.
The NCCN guidelines for diagnosis include:
• Physical exam to check for signs
• Complete blood count (CBC)
• Blood chemistry analysis
• Cytogenetic techniques, to look for certain change in chromosomes (ie: Ph+)
• Bone aspiration and biopsy, to look for abnormal cells
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| (5) With what reference standard does MolecularMD compare the results? |
MolecularMD is the only commercial laboratory to offer QRT-PCR BCR-ABL testing with international reference standards defining MMR, thanks to an exclusive agreement with the lead investigators of the International Randomized Interferon versus STI571 (IRIS) study. To ensure the reliability and reproducibility of every assay, every sample is run against the standards including MMR, for the most accurate BCR-ABL quantification available today. MolecularMD uses ABL as a control gene for two important reasons:
1) The ABL gene transcript is expressed at the same level in the bone marrow and blood, allowing comparison of these tissues during analysis.
2) The ABL gene transcript is expressed at the same level in healthy individuals and in patients with CML, allowing MolecularMD to use ABL to determine assay sensitivity in cases in which the patient is negative for BCR-ABL.
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