PORTLAND, OR and CAMBRIDGE, MA – March 26, 2015 – MolecularMD Corp., a molecular diagnostics company that develops custom companion diagnostics and provides clinical trial testing services for targeted cancer therapies, today announced the recent certification by BSI (British Standards Institution) of its Quality Management System to the requirements of ISO 13485:2003.
The ISO 13485 standard sets the comprehensive requirements for a quality management system (QMS) in the consistent design, development and manufacture of in vitro diagnostic medical devices. Adopting ISO 13485 provides a practical foundation for MolecularMD to demonstrate compliance to laws and regulations of the medical device industry while ensuring that its medical devices are safe for their intended purpose.
PORTLAND, OR and CAMBRIDGE, MA – December 18, 2014 – MolecularMD, Corp., a molecular diagnostics company that develops custom companion diagnostic products and supports clinical trial services for targeted cancer therapies, today announced that it has received accreditation from the College of American Pathologists (CAP) for its Next Generation Sequencing (NGS) Laboratory in Cambridge, MA. To complement its Portland based RT-PCR and IHC companion diagnostic capabilities, the Cambridge laboratory was established in 2012 as an Advanced Diagnostics Development Laboratory for NGS.
MolecularMD has developed a wide range of NGS cancer panels on multiple leading platforms, using proprietary chemistries and data analysis pipeline; it specializes in the design and validation of both tissue and blood-based custom assays for retrospective evaluations and prospective clinical trial enrollment. “Combining our expertise in NGS assay development and robust analytical assay validation process, we offer our clients the highest quality data for drug development and clinical decision-making,” commented Dr. Jin Li, Scientific Director of Advanced Diagnostics at Cambridge Laboratory.
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.