PORTLAND, OR and CAMBRIDGE, MA – June 27, 2016 – MolecularMD Corporation announced today that it has entered into an agreement with Illumina, Inc. (NASDAQ: ILMN) that establishes a framework for potential collaborations with respect to the development and commercialization of sequencing-based companion diagnostics in support of biopharma drug development program(s). The agreement dovetails MolecularMD’s companion diagnostic development and FDA submission experience with Illumina’s NGS technology.
“This agreement is designed to deliver the combined power of Illumina’s NGS technologies with MolecularMD’s ability to tailor a complete clinical development solution including regulatory planning, IDE validations and centralized testing and data management for global patient enrollment and disease monitoring,” stated Dan Snyder, CEO of MolecularMD.
MolecularMD opened its advanced diagnostic laboratory in Cambridge, MA in 2012 with the objective of providing NGS solutions that support clinical trials of oncology drug programs. MolecularMD has since deployed NGS diagnostics over a broad range of drug targets and indications. The ability to support global trials with centralized testing laboratories while simultaneously obtaining necessary regulatory compliance can allow rapid deployment of Illumina based NGS solutions.
“Our goal is to enable our clients with the latest platforms and proven technologies that solve for the challenges that often arise during drug and diagnostic co-development,” stated Snyder. “The ability to collaborate with Illumina on defined projects will greatly aid our clients to mitigate risks and to accelerate their clinical trial programs.”
Partnership Provides State-of-the-Art Patient Stratification Using Quantitative Tissue Assays For
Clinical Development and Diagnostics
Munich, Germany – June 2, 2016 – Definiens, the pioneer in Tissue Phenomics solutions for
diagnostics development and commercialization, today announced a partnership agreement
with MolecularMD to combine MolecularMD’s expertise in specialty diagnostic assays with
Definiens’ quantitative tissue read-outs. MolecularMD is a molecular diagnostics company that
develops custom companion diagnostic products and supports clinical trial services for targeted
“Definiens’ technology already empowers smarter tissue-based diagnostics,” said Merrilyn
Datta, chief commercial officer, Definiens. “This agreement brings together MolecularMD’s
proven track record in clinical assay development and companion diagnostics with Definiens’
unparalleled image analysis platform to provide the confidence of an integrated solution in
The new partnership between the two diagnostics companies provides custom solutions that
meet data and regulatory requirements for both biopharmaceutical clients and academic
medical center oncology programs, including advanced solutions with assays, image analysis
and data mining, combined with deep scientific, regulatory and pathology support.
“MolecularMD is uniquely suited to assist biopharmaceutical clients and academic medical
centers with our clinical trial and regulatory expertise,” said Dan Snyder, president and chief
executive officer, MolecularMD. “I’m thrilled that Definiens and MolecularMD have joined
forces to provide these unique advantages, accelerating pipeline decisions and dramatically
improving patient stratification from the pre-clinical phase.”
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.