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MolecularMD and Genoptix Enter into a Definitive Agreement to Market the MRDx® BCR-ABL Test, a Companion Diagnostic for Treatment-free Remission in Ph+ CML-CP Patients Treated with Tasigna®
PORTLAND, OR and CARLSBAD, CA – June 4, 2018 – MolecularMD Corporation and Genoptix, Inc. announced today that they have entered into an exclusive agreement to market and perform diagnostic testing services and distribution of the MRDx® BCR-ABL Test. The MRDx® BCR-ABL Test is a companion diagnostic that is indicated as an aid in identifying Ph+CML patients in the chronic phase who are on Tasigna®* and are candidates for the initiation and monitoring of Treatment-free Remission. The test received FDA authorization in December 2017 in concordance with the priority review and subsequent label update for the Novartis drug Tasigna, the first and only CML therapy with Treatment-free Remission data in its label. Under the terms of the agreement, Genoptix will exclusively provide MRDx Testing Services and Kits in the United States market.
Treatment-free Remission (TFR) is the ability for eligible patients to sustain major molecular response (MMR) or deep molecular response (DMR) after discontinuing Tasigna, an FDA-approved BCR-ABL tyrosine kinase inhibitor (TKI)1. These patients no longer take daily oral therapy but continue to be actively managed through frequently-scheduled monitoring of molecular response with the MRDx BCR-ABL Test.
The MolecularMD MRDx BCR-ABL Test was clinically validated in conjunction with the ENESTfreedom and ENESTop clinical studies. These trials evaluated the potential to maintain deep molecular response (DMR) after stopping Tasigna therapy among eligible patients 18 years of age or older with Ph+ CML-CP. The trials demonstrated that nearly half of the Ph+ CML-CP patients who discontinued Tasigna remained in TFR nearly two years after stopping treatment.
Genoptix is one of the largest hematopathology centers in the U.S. and is a leading clinical oncology laboratory specializing in hematology and solid tumors. For nearly 20 years Genoptix has served cancer care teams and over 1.7 million patients by delivering fast, accurate vital answers about diagnosis and treatment in hematology and oncology.
“Genoptix is a recognized leader in personalized and comprehensive oncology diagnostic services. The addition of MolecularMD’s MRDx BCR-ABL Test as a Companion Diagnostic with Tasigna enhances Genoptix’s portfolio of minimal residual disease (MRD) clinical monitoring tools and strengthens our position as a leader in hematology oncology,” said Joseph M. Limber, President & Chief Executive Officer, Genoptix.
“Following MolecularMD’s FDA authorization of the MRDx Test for TFR, the commercial partnership with Genoptix will provide broad market access and ensure that CML patients and their healthcare providers receive timely and accurate test results in the management of therapy discontinuation,” stated Dan Snyder, CEO of MolecularMD.
MolecularMD Corporation is a diagnostics company that enables the development and commercialization of precision medicines in oncology. Its tests are designed to allow appropriate selection, monitoring and management of patients treated with molecularly-targeted and immuno- cancer therapies. MolecularMD integrates gold standard and innovative platform technologies with custom clinical assay design and validation to accelerate all phases of clinical development, including FDA approval and commercialization of in vitro companion diagnostic tests for novel anticancer agents. MolecularMD is the exclusive manufacturer of the MRDx BCR-ABL Test. For more information, please visit wwwmolecularmd.com and www.mrdxtest.com.
About Genoptix, Inc.
Genoptix is a leading clinical oncology laboratory specializing in hematology and solid tumors, and operates one of the largest hematopathology centers in the U.S. It provides personalized and comprehensive diagnostic services to hematologists, oncologists and pathologists, with a specialization in diagnosing cancers and disorders in bone marrow, blood and lymph nodes, as well as in solid tumor workups using molecular testing. Through an integrated approach to case management, Genoptix delivers individualized, actionable results for each patient to help the referring physician make the best treatment decision. Genoptix is a portfolio company of Ampersand Capital Partners and 1315 Capital. For more information, please visit www.genoptix.com.
Notes: Genoptix is a registered trademark of Genoptix, Inc. Any other names of actual companies, organizations, entities, products or services may be the trademarks of their respective owners.
*Tasigna is a registered trademark of Novartis AG.
1.Tasigna (nilotinib) Prescribing Information. East Hanover, New Jersey, USA: Novartis Pharmaceuticals Corporation; December 2017.