PORTLAND, OR and CAMBRIDGE, Mass. – June 12, 2014 – MolecularMD Corp., a molecular diagnostics company that provides custom companion diagnostic solutions and supporting clinical trial services for targeted cancer therapies, in collaboration with OncoMed Pharmaceuticals, Inc., will present the development and validation of a proprietary Notch1 Next Generation DNA Sequencing (NGS) test at the upcoming 19th European Hematology Association (EHA) Congress.
At the EHA, MolecularMD and OncoMed will present the validation studies for the proprietary Notch1 NGS assay being developed to identify Notch1 mutation status in patients with certain hematologic malignancies. Notch1 mutations have been linked to more refractory lymphoid malignancies, such as chronic lymphocytic leukemia (CLL), mantle cell lymphoma, and others, putting patients at greater risk for poor outcomes and reduced overall survival. The MolecularMD Notch1 NGS Assay is being developed as a companion diagnostic to identify patients whose cancer may be more likely to benefit from treatment with OncoMed’s anti-Notch1 antibody, OMP-52M51, currently in Phase 1 clinical studies.
CARLSBAD, Calif. – June 2, 2014– MolecularMD will be validating the Oncomine Cancer Research Panel in their CLIA and FDA 21 CFR part 820 compliant diagnostic testing facility to provide comprehensive genomic tumor profiling to support early and late stage clinical development of molecularly targeted cancer therapies.
This comprehensive multi-biomarker assay allows concurrent analyses of DNA and RNA in one workflow, allowing researchers to simultaneously detect all four classes of tumor-driving alterations: single nucleotide variants, copy number variants, tumor suppressors and gene fusions. As CROs and their pharma partners validate their use of this new tool, the potential exists for patients to be more effectively enrolled into clinical trials and study designs made easier.
PORTLAND, OR and CAMBRIDGE, Mass. – April 4, 2014 – MolecularMD Corp., a molecular diagnostics company that provides custom companion diagnostic solutions and supporting clinical trial services for targeted cancer therapies, today announced certification of its Next Generation Sequencing (NGS) clinical laboratory in Cambridge, Massachusetts under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. The Cambridge lab complements MolecularMD’s Portland, OR CLIA lab and GMP manufacturing facility to provide custom solutions for NGS-based companion diagnostics. The lab was initially established as a development center of excellence for NGS and has now been expanded as a dedicated center for NGS clinical testing under CLIA to support early stage and pivotal clinical studies.
Portland, OR, March 5, 2014 -- MolecularMD Corp. today announced that it has launched the NanoString nCounter® Analysis System for multiplex biomarker evaluation in support of oncology clinical drug development. Several types of gene panels are offered for clinical trial applications, including custom-designed multiplex analyses of gene expression, gene fusions, and copy number variation (CNV). As an nCounter Core Lab, MolecularMD has qualified the nCounter System in its Portland CLIA-certified laboratory where it will offer analytically validated pre-built panels and custom assays on the NanoString platform.
Portland, OR, February 19, 2014 -- MolecularMD Corp. today announced that it has entered into a collaboration with Novartis Pharmaceuticals Corporation to develop a companion diagnostic test to aid in the identification of Ph+ chronic myelogenous leukemia (CML) patients who have achieved durable minimal residual disease (MRD) with nilotinib (Tasigna®), and to provide molecular monitoring for patients during treatment-free remission.
MolecularMD will validate an in vitro companion diagnostic test (IVD) designed specifically to monitor CML patients during treatment-free remission. Clinical studies are currently ongoing to evaluate whether patients can maintain MRD after stopping nilotinib therapy, also called treatment-free remission.