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.
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
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.
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.
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.