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MolecularMD, Novartis team up on companion diagnostic test development.

M2 PHARMA-February 19, 2014-MolecularMD, Novartis team up on companion diagnostic test development


19 February 2014 - US molecular diagnostics company MolecularMD Corp said Wednesday it had partnered with Novartis Pharmaceuticals Corp, the US unit of Swiss Novartis AG (VTX:NOVN), for the development of a companion diagnostic test to detect Ph+ chronic myelogenous leukemia (CML) patients who have achieved durable minimal residual disease (MRD) with Tasigna (nilotinib).

MolecularMD will validate an in-vitro companion diagnostic test intended to monitor CML patients during treatment-free remission. The assay is based on highly sensitive quantitative real-time PCR (RT-qPCR) identification of BCR-ABL mRNA transcripts and the endogenous ABL mRNA transcript control in peripheral blood specimens from CML patients.

Novartis is currently carrying out an international clinical study programme to find if nilotinib therapy can be safely suspended with no recurrence of CML in selected patients who achieved MR4.5 (BCR-ABL less than or equal to 0.0032% IS) on nilotinib therapy. MolecularMD is engaged in the clinical trial assay (CTA) quantifying of BCR-ABL mRNA transcript levels in the study.

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Publication:M2 Pharma
Date:Feb 19, 2014
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