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MolecularMD, Novartis to Develop Test to Monitor Treatment-Free Remission for CML Drug Trial

NEW YORK (GenomeWeb News) – MolecularMD said today it is working with drug firm Novartis to develop a companion diagnostic that can help determine which Philadelphia chromosome-positive chronic myeloid leukemia patients have achieved durable minimal residual disease after treatment with Tasigna (nilotinib).

Tasigna is Novartis' next-generation tyrosine kinase inhibitor used to treat patients with newly diagnosed Philadelphia chromosome-positive CML in chronic phase.

Novartis is conducting a study to gauge whether Tasigna can be safely suspended when patients achieve the treatment-free remission phase, meaning they aren't experiencing recurrence and have BCR-ABL levels less than or equal to 0.0032 percent on the international scale. However, once patients reach this phase and stop taking Tasigna, they need to be monitored to ensure that they continue to remain in "deep remission" and aren't relapsing.

In a single-arm, multi-center trial, Novartis will enroll patients with Philadelphia chromosome-positive CML in chronic phase who have achieved durable minimal residual disease status. MolecularMD will develop the clinical trial assay that will help researchers in this study determine patients' BCR-ABL mRNA transcript levels. MolecularMD will develop the test on a real-time PCR platform and validate the IVD.

In 2010, Novartis inked a deal with Cepheid for the development of a test for monitoring BCR-ABL gene transcripts to help doctors more reliably manage Philadelphia chromosome-positive CML patients on Gleevec (imatinib).

Novartis and MolecularMD did not reveal financial or other terms of their deal.