THE ONLY

FDA-Authorized Test for Treatment-free Remission Initiation and Monitoring for Chronic Myeloid Leukemia Patients in the Chronic Phase

About MRDx Test MRDx® BCR-ABL Test

The FDA Authorized Test for TFR Initiation and Monitoring

The MRDx® BCR-ABL Test is a companion diagnostic for Chronic Myeloid Leukemia (CML) patients in the chronic phase (CP) being treated with Tasigna®* who may be candidates for treatment discontinuation and monitoring of treatment-free remission (TFR).

Monitoring of TFR requires the ability to accurately measure BCR-ABL transcripts to a depth, classified as MR4.5 (BCR-ABL/ABL ≤0.0032% International Scale).

The MRDx BCR-ABL Test has consistently demonstrated sensitivity in ENESTfreedom and ENESTop clinical studies to MR4.5.

The MRDx BCR-ABL Test is based on real-time quantitative PCR and measures BCR-ABL transcripts (e13a2/b2a2 and/or e14a2/b3a2) from peripheral blood specimens in Ph+ CML-CP patients.

*Tasigna is a registered trademark of Novartis AG


Related Resources

Treatment-free remission necessitates monthly monitoring with an accurate, precise, and highly sensitive assay.

While many labs offer BCR-ABL testing, few if any have been through the rigor of the MRDx BCR-ABL Test which was utilized as a clinical trial assay for nearly 7,000 patient visits in order to determine eligibility and monitoring for TFR.

It is the only FDA-authorized companion diagnostic for Tasigna and will give physicians the assurance to incorporate TFR into their standard of care treatment modality.

Chad Galderisi, MolecularMD Corp.

Executive Vice President | Chief Medical Officer | Laboratory Director

MRDx® Companion Diagnostic Kit

Conquering CML: The Breakthrough Paradigm Change of Treatment-free Remission

The MRDx® Test is available as an in vitro diagnostic kit for laboratory use. The test is a companion diagnostic used in conjunction with Tasigna® to identify, initiate, and monitor Treatment-free Remission, which enables patients to safely go off the drug.

Based on real-time RT-PCR, the test accurately measures BCR-ABL transcript levels and reports molecular response to MR4.5 (0.0032%IS).

See how the test can help your laboratory aid physicians in treatment-free monitoring.

CML Testing Services

MRDx® BCR-ABL Testing Services

The MolecularMD Clinical Laboratory is a CAP-accredited, CLIA certified facility that has been servicing the needs of health care professionals who are managing the treatment of their CML patients. For over 12 years, the Portland laboratory has offered advanced diagnostic testing services to clients.

MolecularMD has partnered with Genoptix Inc., a leading oncology laboratory specializing in hematology and solid tumor testing, as the commercial laboratory provider of the MRDx® BCR-ABL Test for treatment-free remission (TFR) initiation and/or monitoring services. Genoptix, located in Carlsbad, CA, will perform BCR-ABL testing using the MolecularMD MRDx® BCR-ABL Test.

Effective immediately, MolecularMD has transitioned all physician-ordered MRDx® BCR-ABL testing to Genoptix. For more information, please contact Genoptix Client Services at clientservices@genoptix.com or +1.800.755.1605 for updated shipping and testing requirements.

MolecularMD will continue to perform testing services for clinical trial applications. For further information on MRDx® Test for clinical trials, please contact us at getmrdx@molecularmd.com or +1-866-GET-MRDX (438-6379).

Read the News Release

Clinical Use

Assess treatment-free remission (TFR) in Ph+ CML-CP patients.


Clinical Background

* The MRDx® BCR-ABL Test is for professional use only.

Get MRDx® Now

MolecularMD has partnered with Genoptix Inc., a leading oncology laboratory specializing in hematology and solid tumor testing, as the commercial laboratory provider of the MRDx® BCR-ABL Test for treatment-free remission (TFR) initiation and/or monitoring services. Genoptix, located in Carlsbad, CA, will perform BCR-ABL testing using the MolecularMD MRDx® BCR-ABL Test.

Effective immediately, MolecularMD has transitioned all physician-ordered MRDx® BCR-ABL testing to Genoptix. For more information, please contact Genoptix Client Services at clientservices@genoptix.com or +1.800.755.1605 for updated shipping and testing requirements. We appreciate your past business and are available to answer any additional questions concerning the transition of physician-ordered MRDx® BCR-ABL testing to Genoptix.

Frequently Asked Questions
Can I use the MolecularMD-provided specimen collection kit for testing at Genoptix?
No, please discard any MolecularMD-provided specimen collection kits and contact Genoptix to obtain new collection kits.

If a sample is currently en route to MolecularMD, will MolecularMD still test and report results?
Further testing at MolecularMD of MRDx® BCR-ABL specimens will occur only for samples currently en route to our Portland, OR laboratory. Samples received at MolecularMD cannot be transferred to Genoptix due to stability concerns.

How do I interpret the MRDx® BCR-ABL Test results from both MolecularMD and Genoptix?
BCR-ABL values from either laboratory are reported on the International Scale (IS).

MolecularMD will continue to perform testing services for clinical trial applications. For further information on MRDx® Test for clinical trials, please complete the inquiry form below.

*The MRDx® BCR-ABL Test is for professional use only.

MolecularMD
1342 SW Custer Drive
Portland, OR 97219

Toll free: 1-866-GET-MRDX (438-6379) 1-866-GET-MRDX (438-6379)
Email: getmrdx@molecularmd.com

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