Genoptix Launches FDA-Authorized BCR-ABL MRDx® TFR Monitoring Test for Patients with Chronic Myeloid Leukemia on Tasigna® (nilotinib)
CARLSBAD, CA (September 4, 2018) – Genoptix, Inc., a leading oncology diagnostic laboratory, announces the immediate availability of a proprietary, FDA-authorized BCR-ABL MRDx® TFR Monitoring Test for patients with chronic myeloid leukemia (CML) being treated with Tasigna® (nilotinib). The test is commercially available in the U.S. exclusively through Genoptix. The BCR-ABL MRDx® TFR Monitoring Test is the only diagnostic test authorized by the Food and Drug Administration for the management of patients on tyrosine kinase inhibitors. The BCR-ABL MRDx® TFR Monitoring Test received FDA authorization in accordance with the priority review and subsequent label update for Tasigna® (nilotinib) for treatment-free remission (TFR).
TFR is an emerging goal in patient care that enables physicians to safely and successfully discontinue tyrosine kinase therapy with appropriate patients and continue to monitor patients for potential retreatment. Treatment-free remission means that the utilization of tyrosine kinase therapy for patients with CML no longer needs to be considered a lifelong treatment. The benefits of TFR may include optimized patient management and healthcare cost savings. Cancer guidelines support frequently scheduled molecular monitoring to safely discontinue therapy and help predict early relapse of disease. Frequent utilization of the BCR-ABL MRDx® TFR Monitoring Test may have a profound impact on patient management and shaping the course of CML for each individual.
“The addition of the BCR-ABL MRDx® TFR Monitoring Test will expand Genoptix’s portfolio of minimal residual disease tests and enhance our position in oncology diagnostics. This is a tremendous advancement to improve patient’s quality of life and reduce healthcare costs,” said Joseph M. Limber, President and Chief Executive Officer of Genoptix.
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. With over 1.7 million patients and counting, Genoptix sets a higher standard of quality, from science to service. 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.
*MRDx is a registered trademark of MolecularMD.