MolecularMD announced it has entered an exclusive agreement with clinical oncology laboratory Genoptix to market and perform the testing services for the MRDx BCR-ABL test, a companion diagnostic that identifies Ph+CML patients in the chronic phase taking Tasigna who are eligible for initiation and monitoring of treatment-free remission (TFR).
TFR is the ability of some patients to sustain major molecular response (MMR) or deep molecular response (DMR) after discontinuing Tasigna, a BCR-ABL tyrosine kinase inhibitor (TKI)1. Under this regimen, patients no longer take Tasigna but are managed through frequently scheduled monitoring of molecular response with the MolecularMD’s MRDx BCR-ABL companion diagnostic.
“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,” said Dan Snyder, CEO of MolecularMD, in a press release.
The MRDx BCR-ABL test received FDA approval late last year.
For Genoptix, it’s selection as MolecularMD’s exclusive provider of the MRDx BCR-ABL diagnostic further broadens its menu of both hematology and solid tumor testing services.
“Genoptix is a recognized leader in personalized and comprehensive oncology diagnostic services,” said Joseph M. Limber, president and CEO of Genoptix. “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.”