PORTLAND, OR and CAMBRIDGE, Mass. – April 4, 2014 – MolecularMD, Inc., 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.
Portland, OR, December 5, 2013 – MolecularMD Corp., a molecular diagnostics company focused on providing the highest quality companion diagnostics and clinical trials support services to oncology drug developers, announced today that its tests will be highlighted in several presentations at the upcoming 55th Annual Meeting of the American Society of Hematology (ASH) taking place December 7-10th in Atlanta, GA.
MolecularMD scientists will present two posters describing new molecular diagnostic methodologies for analysis of BCR-ABL1 in CML, the MRDx BCR-ABL Test and the ABL1 Phasing Test. The MRDx BCR-ABL Test is an exquisitely sensitive quantitative real-time PCR test that is appropriate for measuring minimal residual disease in CML patients, and monitoring patients in molecular remission, and the ABL1 Phasing Test uses a Next Generation Sequencing approach to enable determination of phasing of compound mutations in BCR-ABL1. Furthermore, in collaboration with ARIAD Pharmaceuticals, Inc. and its clinical investigators, clinical data from a study using the MolecularMD ABL1 Phasing Test will be presented in an oral session.
Portland, OR, November 6, 2013 – MolecularMD Corp., a molecular diagnostics company focused on providing the highest quality companion diagnostics and clinical trials support services to oncology drug developers, announced today that it will be presenting a poster at each of four upcoming conferences: ASCO-EORTC-NCI Markers in Cancer, Circulating Nucleic Acids in Plasma and Serum (CNAPS VIII), Association for Molecular Pathology (AMP) Annual Meeting, and the 10th International Congress of the Society for Melanoma Research.
The presentations cover topics that highlight MolecularMD’s technical achievements in assay development addressing the challenges presented by the clinical need for comprehensive genotyping data using limited source material such as plasma circulating solid tumor DNA and FFPE biopsy tissue.