Conquering CML The Breakthrough Paradigm Change of Treatment-free Remission - 12

Conquering CML | The Breakthrough Paradigm Change of Treatment-free Remission

Q&A

Chad Galderisi
CO: How did MolecularMD first start working with
CHAD GALDERISI is Executive Vice President, Chief
Medical Officer and a Scientific Co-founder of MolecularMD,
which created the MRDx BCR-ABL companion diagnostic for
the Novartis drug Tasigna® (nilotinib) to measure whether
chronic myeloid leukemia (CML) patients with sustained
deep molecular response could safely discontinue therapy and remain in treatment free remission (TFR). Here,
Dr. Galderisi describes the creation of the diagnostic and
how MolecularMD was awarded the contract from Novartis
based on the superiority of its BCR-ABL test.

12

A Clinical OMICs eBook

Novartis on nilotinib?

Galderisi: In April of 2012 Novartis needed a robust, sensitive,
and precise assay capable of reliably detecting at least MR4.5
and also distinguishing MR4 from MR4.5 which is required for
patients attempting TFR.
The clinical trial assay was designed, developed, and validated
in less than three months in order to meet the extremely
ambitious Novartis timeline to start testing all patients for the
consolidation phase of their TFR clinical trials.

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Conquering CML The Breakthrough Paradigm Change of Treatment-free Remission

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