Oncology Drug Approval - Accelerated

Bridging the gap between biomarkers and In Vitro Companion Diagnostics

MolecularMD Receives ISO Certification for Design, Development and Production of Molecular Diagnostic Products

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.


MolecularMD Cambridge Laboratory Receives CAP Accreditation with Focus on NGS Panels for Clinical Trial Enrollment and NGS Liquid Biopsy Testing

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.


MolecularMD Develops Notch1 Next Generation Sequencing Test to Support Clinical Development for OncoMed's anti-Notch1 antibody, OMP-52M51

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.


MolecularMD to Adopt Oncomine Cancer Research Panel with Ion Torrent Next-Generation Sequencing Platform

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.


MolecularMD Receives CLIA Certification for its Second Next Generation Sequencing Laboratory

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.


More Articles...

  1. MolecularMD Launches NanoString Platform for Multiplexed Digital Evaluation of Gene Expression and Copy Number Variation in Clinical Specimens
  2. MolecularMD to Develop Highly Sensitive Companion Diagnostic Test to Support CML Treatment Free Remission Clinical Trial
  3. MolecularMD Announces Presentations at Upcoming American Society of Hematology Annual Meeting
  4. MolecularMD Announces Presentations at Four Upcoming Scientific Conferences
  5. Personal Genome Diagnostics and MolecularMD Collaborate to Provide Advanced Genomic Testing Services to Cancer Drug Developers
  6. MolecularMD Announces Presentations at Upcoming AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
  7. Glenn Miller, Ph.D., Joins MolecularMD as Chief Technology Officer and Executive Vice President
  8. MolecularMD Corp. Obtains License to Commercialize Predictive Diagnostic Based on Actionable Biomarker, DDR2, for Uses in Lung Cancer and Targeted Kinase Therapy
  9. MolecularMD Corp. Offers Testing Services for Determining LKB1 Mutation and Expression Status
  10. MolecularMD Announces Launch of Next Generation Sequencing Services for Oncology Drug Development
  11. MolecularMD Corp. Obtains Exclusive License to LKB1 Uses in Non-Small Cell Lung Cancer
  12. MolecularMD and Ventana Medical Systems, Inc. reach Collaborative Research Agreement: Limits of detection and sensitivity for PTEN gene using in-situ hybridization and immunohistochemistry methods
  13. MolecularMD Announces Next Generation Sequencing Presentation at Upcoming American Society of Hematology Annual Meeting
  14. MolecularMD Announces Three Presentations Highlighting Non-Invasive Biomarker Detection and NGS Validation at Upcoming Scientific Conferences
  15. MolecularMD and ARIAD Announce Voluntary Withdrawal Of MolecularMD’s Premarket Approval Application For BCR-ABL T315I Mutation Test
  16. MolecularMD Submits Premarketing Approval Application to the FDA for its BCR-ABL T315I Mutation Test, a Companion Diagnostic to Ponatinib, an investigational BCR-ABL inhibitor
  17. MolecularMD Closes $6 Million Series B Financing And Announces Ensuing Growth Initatives
  18. MolecularMD Announces Issuance Of Patent Covering Methods For Therapeutic Resistance Monitoring In Lung Cancer Patients
  19. Medco Partners with MolecularMD on Personalized Medicine Program for Chronic Myeloid Leukemia
  20. Ariad And MolecularMD Announce Collaboration For A Companion Diagnostic Test For The T315I BCR-ABL Mutation In Patients With CML

Oncology Thought Leaders Series:
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