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MolecularMD, Genoptix Ink Marketing Agreement for CDx to Novartis CML Drug

NEW YORK (GenomeWeb) – Diagnostics firm MolecularMD has signed an exclusive agreement with clinical oncology laboratory Genoptix to market, distribute, and perform diagnostic testing services for the MRDx BCR-ABL companion diagnostic test.

Under the terms of the agreement, Genoptix will be the exclusive provider in the US of MRDx testing services and kits. Financial terms of the deal were not disclosed.

The MolecularMD test — which was authorized by the US Food and Drug Administration about six months ago — is a real-time PCR-based assay intended to identify chronic myeloid leukemia patients taking the Novartis drug Tasigna (nilotinib) who are Philadelphia chromosome positive and are candidates for stopping treatment and starting treatment-free remission (TFR) monitoring. Specifically, these patients no longer take daily oral therapy with Tasigna but continue to have frequent monitoring of their molecular response using the MRDx BCR-ABL test.

"The addition of MolecularMD's MRDx BCR-ABL Test as a companion diagnostic with Tasigna enhances Genoptix's portfolio of minimal residual disease clinical monitoring tools and strengthens our position as a leader in hematology oncology," Genoptix President and CEO Joseph Limber said in a statement.

"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," added MolecularMD CEO Dan Snyder.