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July 02, 2015 12:39 PM ET

Life Sciences Tools and Services

Company Overview of MolecularMD Corp.

Company Overview

MolecularMD Corp. develops and commercializes molecular diagnostics for oncology applications. It provides molecular diagnostics products and services to support clinical development, regulatory approval, and commercialization of targeted cancer therapies. The company offers reference laboratory services, such as BCR-ABL1 quantification services; BCR-ABL1, BRAF, cKIT, KRAS, and NRAS profiler mutation testing; and PGx profiler mutation screening. It also provides clinical trial services, such as customized reporting, trial site support, investigator education, laboratory certification, test capacity, and data management. In addition, it offers companion diagnostics services. The company serve...

1341 SW Custer Drive

Portland, OR 97219

United States

Founded in 2005

Phone:

503-459-4974

Fax:

503-459-4976

Key Executives for MolecularMD Corp.

Chief Executive Officer, President and Director
Scientific Co-Founder and Scientific Advisor
Chief Medical Officer, Executive Vice President, Laboratory Director and Director
Scientific Co-Founder
Chief Technology Officer and Executive Vice President
Compensation as of Fiscal Year 2015.

MolecularMD Corp. Key Developments

MolecularMD Corp. Launches the NanoString nCounter Analysis System for Multiplex Biomarker Evaluation

MolecularMD Corp. 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. 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. Advantages of the nCounter System include its precision, sensitivity, efficiency, and scope of data generated. With no amplification step, the single molecule digital counting removes amplification bias and enhances the quality of the data. Input requirements are flexible, allowing sample types such as FFPE tissue, fresh tissue, and whole blood lysate with turn-around times comparable to RT-PCR.

MolecularMD Corp. Enters into a Collaboration with Novartis Pharmaceuticals Corporation to Develop a Companion Diagnostic Test to Aid in the Identification of Ph+ Chronic Myelogenous Leukemia

MolecularMD Corp. 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(R)), 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. The test design is based on highly sensitive quantitative real-time PCR (RT-qPCR) detection of BCR-ABL mRNA transcripts and the endogenous ABL mRNA transcript control in peripheral blood specimens from patients previously diagnosed with CML. Novartis is conducting a global clinical trial program to investigate whether nilotinib treatment can be safely suspended, called the treatment-free remission phase, with no recurrence of CML in selected patients who obtained MR4.5 on nilotinib therapy. Once treatment is stopped, molecular monitoring is used to identify if a patient's level of disease remains in deep molecular response or if the reintroduction of treatment is needed. The program includes a single-arm, multicenter clinical trial to evaluate patients with Ph+ CML in chronic phase who have achieved durable MRD status. Molecular determination of MRD status may be made by sensitive detection of BCR-ABL mRNA transcript levels. MolecularMD is performing the clinical trial assay (CTA) quantifying BCR-ABL mRNA transcript levels for this trial.

Personal Genome Diagnostics and MolecularMD Collaborate to Provide Advanced Genomic Testing Services to Cancer Drug Developers

Personal Genome Diagnostics, Inc. announced that it will collaborate with MolecularMD to market a suite of comprehensive personalized medicine services to oncology researchers and drug developers, adding PGDx’s expertise in Next-Generation Sequencing (NGS)-based cancer biomarker discovery to MolecularMD’s capabilities in the development, validation and global delivery of cancer companion diagnostics. The collaboration is designed to provide a unique specialized service to the pharmaceutical and biotechnology industry, seamlessly spanning the entire spectrum of genomic and clinical trial services used in new drug R&D and clinical development. Under the terms of the agreement, the two companies will co-market each other’s services to their pharmaceutical and biotechnology customers. PGDx provides advanced genome mapping services and analyses to oncology researchers, clinicians and patients. It employs cancer exome analysis, which enables comprehensive, reliable and unbiased genome-wide identification of cancer-related mutations. The company’s proprietary methods for genome sequencing and analysis are complemented by its deep expertise in cancer genomics. MolecularMD provides molecular diagnostics products and services to pharmaceutical and biotechnology drug developers. Its capabilities range from specialty molecular testing services performed in its CLIA-certified and CAP-accredited laboratory to development of companion diagnostics that support new drug registrations. It also provides NGS services for clinical trials, including standard and custom-designed panels that can profile gene alterations relevant to therapeutic response or resistance.

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