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.

Please call the MolecularMD Billing Department (1-877-459-4979 x305) for more information or see the Billing and Reimbursement section of the FAQs for more information.

BCR-ABL RNA is extracted from a blood or bone marrow sample and is measured using QRT-PCR.

To reliably detect and reproduce BCR-ABL levels at MMR, the assay needs to have 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).

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.

Blood samples must be collected in EDTA (lavender-top) tubes and shipped overnight, as they must be received within 24 hours of collection. Samples must be sent at room temperature.

For samples that require longer than 24 hours for shipping, alternative collection and shipment protocols are available. Please contact Customer Service at 1-877-459-4979 for information.

To ensure reliable results, MolecularMD has established quality controls at every step of the assay, from blood RNA extraction to re-verification of results before pathologist sign off. For example:

• The Reverse Transcription (RT) efficiency step is measured with three RNA quality controls:
  High BCR-ABL levels, mimicking baseline untreated patients
  BCR-ABL MMR level
  BCR-ABL negative
• PCR efficiency for BCR-ABL and ABL is measured with 6 plasmid quality controls over a 5-log range with:
  Quantitation accuracy down to 3 copies of BCR-ABL
• MolecularMD has quality control and quality assurance software with specific restrictions to ensure that correct QC roles and control measurements are performed for all steps in the BCR-ABL quantitation assay
• MolecularMD has several external programs for QC testing of BCR-ABL quantitation with leading IRIS academic laboratories and professional accreditation agencies such as College of American Pathologists (CAP). The laboratory is also subject to two annual Minimal Residual Disease (MRD) surveys as regulated for proficiency testing by the Centers for Medicare and Medicaid Services (CMS).

Peripheral whole blood, bone marrow, frozen cells or RNA can be tested. Please contact Customer Service at 1-877-459-4979 if you wish to ship RNA or frozen cells.

The sample collection protocol is standard phlebotomy.

To request a sample collection kit, call Customer Service at 1-877-59-4979 or download from the website. Kits take approximately 5 business days to arrive. View our shipping guidelines for more information.

Yes, you may use your own supplies. Collect blood in EDTA (lavender-top) tubes and place in a biohazard bag with absorbent material for shipping. Biohazard bags should be packed in bubble wrap and shipped at room temperature for overnight delivery.

Yes, the information will remain confidential. All involved employees have been trained on the requirements of the Health Insurance Portability and Accountability Act (HIPPA). Our database is also HIPAA compliant.

No. BCR-ABL quantitation must be ordered by a physician.

No, fasting is not necessary before the blood draw.

Molecular MD is certified and accredited by Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists (CAP).

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.

Molecular MD is certified and accredited by Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists (CAP).
The scientific founders of MolecularMD are:

• Brian Druker, M.D.
• Michael Heinrich, M.D.
• Chad Galderisi, D.O. - Also MolecularMD Laboratory Director

MolecularMD currently performs the following tests:

• BCR-ABL Quantitation Assay
• BCR-ABL T315I Assay
• BCR-ABL Kinase Domain Sequencing

Read more about BCR-ABL Quantitation
Read more about BCR-ABL Mutation Testing