Oncology Biomarker Diagnostics

Linking molecular status to breakthroughs in cancer treatment

MolecularMD Receives CLIA Certification for its Second Next Generation Sequencing Laboratory

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.

Read more...

MolecularMD Launches NanoString Platform for Multiplexed Digital Evaluation of Gene Expression and Copy Number Variation in Clinical Specimens

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.

Read more...

MolecularMD to Develop Highly Sensitive Companion Diagnostic Test to Support CML Treatment Free Remission Clinical Trial

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.

Read more...

MolecularMD Announces Presentations at Upcoming American Society of Hematology Annual Meeting

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.    

Read more...

MolecularMD Announces Presentations at Four Upcoming Scientific Conferences

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. 

Read more...

More Articles...

  1. Personal Genome Diagnostics and MolecularMD Collaborate to Provide Advanced Genomic Testing Services to Cancer Drug Developers
  2. MolecularMD Announces Presentations at Upcoming AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
  3. Glenn Miller, Ph.D., Joins MolecularMD as Chief Technology Officer and Executive Vice President
  4. MolecularMD Corp. Obtains License to Commercialize Predictive Diagnostic Based on Actionable Biomarker, DDR2, for Uses in Lung Cancer and Targeted Kinase Therapy
  5. MolecularMD Corp. Offers Testing Services for Determining LKB1 Mutation and Expression Status
  6. MolecularMD Announces Launch of Next Generation Sequencing Services for Oncology Drug Development
  7. MolecularMD Corp. Obtains Exclusive License to LKB1 Uses in Non-Small Cell Lung Cancer
  8. 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
  9. MolecularMD Announces Next Generation Sequencing Presentation at Upcoming American Society of Hematology Annual Meeting
  10. MolecularMD Announces Three Presentations Highlighting Non-Invasive Biomarker Detection and NGS Validation at Upcoming Scientific Conferences
  11. MolecularMD and ARIAD Announce Voluntary Withdrawal Of MolecularMD’s Premarket Approval Application For BCR-ABL T315I Mutation Test
  12. 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
  13. MolecularMD Closes $6 Million Series B Financing And Announces Ensuing Growth Initatives
  14. MolecularMD Announces Issuance Of Patent Covering Methods For Therapeutic Resistance Monitoring In Lung Cancer Patients
  15. Medco Partners with MolecularMD on Personalized Medicine Program for Chronic Myeloid Leukemia
  16. Ariad And MolecularMD Announce Collaboration For A Companion Diagnostic Test For The T315I BCR-ABL Mutation In Patients With CML
  17. MolecularMD Corp. Obtains Exclusive License from NYU and MSKCC for BRAF Melanoma Assay
  18. MolecularMD Establishes New Operations Facility to Support Growth in Personalized Cancer Medicine Business
  19. MolecularMD and Mayo Clinic Enter into Sub-License Agreement for the Detection of Drug Resistant Mutations in Leukemia Patients.
  20. Ballast Point Ventures Invests In MolecularMD Corporation

Oncology Thought Leaders Series:
Brian Druker, MD speaks on the value of
companion diagnostics in patient outcomes