Oncology Drug Approval - Accelerated

Bridging the gap between biomarkers and In Vitro Companion Diagnostics

MolecularMD has obtained CE Marking of a Diagnostic Assay Developed for a Daiichi Sankyo, Inc. Phase II Clinical Trial

PORTLAND, OR and CAMBRIDGE, MA – April 25, 2016 – MolecularMD Corp., a molecular diagnostics company that accelerates oncology drug development by providing custom companion diagnostic solutions and supporting clinical trial services for targeted cancer therapies, has partnered with Daiichi Sankyo, Inc. on their work in developing oncology compounds. In collaboration with Daiichi Sankyo, MolecularMD has validated a clinical trial assay that will be used to enrich the patient population for a Phase II clinical trial which is commencing in Europe. MolecularMD has completed the CE registration with the European authorities to ensure future access as an assay, which is to be used for patient selection into the trial.

“Identifying the precise subset of patients who may respond to our compound helps to fully assess its potential efficacy and safety profile,” said Antoine Yver, MD, MSc, Executive VP and Global Head, Oncology R&D, Daiichi Sankyo.

“MolecularMD is entirely focused on accelerating development  of precision oncology medicines. Our work with Daiichi Sankyo demonstrates our ability to support a wide spectrum of clinical and regulatory strategies, stated Dan Snyder, CEO of MolecularMD. “We have a long standing and successful collaboration with their team”. The arrangement with Daiichi Sankyo represents just one of MolecularMD’s Master Service Agreements among the top 25 prominent BioPharma companies in the Industry.  

MolecularMD Announces Presentations at Upcoming AACR-NCI-EORTC International Conference

PORTLAND, OR and CAMBRIDGE, MA – November 3, 2015 – MolecularMD, Corp., a molecular diagnostics company that develops custom companion diagnostic products and supports clinical trial services for targeted cancer therapies, today announced that its liquid biopsy capability will be highlighted in a presentation at the upcoming AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics taking place November 5 -9 in Boston, MA. 

MolecularMD will present a poster describing the use of an amplicon based target enrichment method to study a set of tumor/plasma pairs collected from stage IV colon cancer patients to determine whether amplicon based NGS can be used to profile mutations in ctDNA from colorectal cancer patients.

AACR Presentation Details:

Title:  Mutation Profiling of Colorectal Cancer ctDNA using AmpliSeq CHP2 Cancer Panel

Session ID: Poster Session A

Session Title:  Biomarkers

Date & Time:  Friday, November 6, 2015; 12:15 PM – 3:15 PM

Location: Exhibit Hall C-D

Abstract Number:  A29

MolecularMD Receives New York State Approval for Next Generation Sequencing Test to Support Clinical Trial Enrollment

PORTLAND, OR and CAMBRIDGE, MA – July 16, 2015 – MolecularMD Corp., a molecular diagnostics company that provides companion diagnostic solutions and supporting clinical trial testing services for targeted cancer therapies, received approval from the New York State Department of Health (NYDOH) for its Next Generation Sequencing (NGS) Notch 1 gene mutation analysis in FFPE tissue and whole blood specimens. The test is intended to support clinical trial enrollment.

Notch1 mutations have been linked to 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 approval was based on New York State’s “NGS guidelines for somatic genetic variant detection.”  The guidelines cover all aspects of ensuring accurate test performance including validation, quality control, and reporting. The NYDOH guidelines are considered to be one of the most comprehensive NGS guideline references by a government body.  Tests submitted for approval are given meticulous evaluation.  

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MolecularMD Announces Presentations at Upcoming American Association for Cancer Research Annual Meeting

PORTLAND, OR and CAMBRIDGE, MA – April 16, 2015 – MolecularMD, Corp., a molecular diagnostics company that develops custom companion diagnostic products and supports clinical trial services for targeted cancer therapies, today announced that its Next Generation Sequencing (NGS) capability will be highlighted in two presentations at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2015 taking place April 18 -22 in Philadelphia, PA. 

MolecularMD scientists will present two posters describing the validation of Oncomine® Cancer Research Panel for comprehensive analysis of FFPE tumor samples, and the application of Ion AmpliSeq™ v2 Cancer Panel gene panel for Liquid Biopsy.

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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.

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More Articles...

  1. MolecularMD Cambridge Laboratory Receives CAP Accreditation with Focus on NGS Panels for Clinical Trial Enrollment and NGS Liquid Biopsy Testing
  2. MolecularMD Develops Notch1 Next Generation Sequencing Test to Support Clinical Development for OncoMed's anti-Notch1 antibody, OMP-52M51
  3. MolecularMD to Adopt Oncomine Cancer Research Panel with Ion Torrent Next-Generation Sequencing Platform
  4. MolecularMD Receives CLIA Certification for its Second Next Generation Sequencing Laboratory
  5. MolecularMD Launches NanoString Platform for Multiplexed Digital Evaluation of Gene Expression and Copy Number Variation in Clinical Specimens
  6. MolecularMD to Develop Highly Sensitive Companion Diagnostic Test to Support CML Treatment Free Remission Clinical Trial
  7. MolecularMD Announces Presentations at Upcoming American Society of Hematology Annual Meeting
  8. MolecularMD Announces Presentations at Four Upcoming Scientific Conferences
  9. Personal Genome Diagnostics and MolecularMD Collaborate to Provide Advanced Genomic Testing Services to Cancer Drug Developers
  10. MolecularMD Announces Presentations at Upcoming AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
  11. Glenn Miller, Ph.D., Joins MolecularMD as Chief Technology Officer and Executive Vice President
  12. MolecularMD Corp. Obtains License to Commercialize Predictive Diagnostic Based on Actionable Biomarker, DDR2, for Uses in Lung Cancer and Targeted Kinase Therapy
  13. MolecularMD Corp. Offers Testing Services for Determining LKB1 Mutation and Expression Status
  14. MolecularMD Announces Launch of Next Generation Sequencing Services for Oncology Drug Development
  15. MolecularMD Corp. Obtains Exclusive License to LKB1 Uses in Non-Small Cell Lung Cancer
  16. 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
  17. MolecularMD Announces Next Generation Sequencing Presentation at Upcoming American Society of Hematology Annual Meeting
  18. MolecularMD Announces Three Presentations Highlighting Non-Invasive Biomarker Detection and NGS Validation at Upcoming Scientific Conferences
  19. MolecularMD and ARIAD Announce Voluntary Withdrawal Of MolecularMD’s Premarket Approval Application For BCR-ABL T315I Mutation Test
  20. 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

Watch the short video below to learn more about how MolecularMD develops and commercializes specialty molecular diagnostics for oncology applications.