Who We Are

MolecularMD Provides Clients with a Full-service Diagnostics Offering Designed to Accelerate Oncology Drug Approval

MolecularMD (MMD) streamlines the co-development and commercialization of molecular diagnostic tests that are deployed and leveraged across the continuum of the drug development process. Our capabilities are broad with significant scientific capabilities, which include:

  • Assay design and development services
  • Sample banking and bridging strategies
  • Clinical trial design
  • Regulatory planning
  • Analytical and clinical assay validation
  • Full-service histology and pathology offerings; including immunohistochemistry (IHC) assay development
  • FDA submission services
  • Custom clinical GMP kit manufacturing.

MMD works with its clients to manage risks and optimize their ROI by providing flexible, platform-agnostic diagnostic services, an uncommon approach and one that is not well served by contract research organizations (CROs) or in-vitro diagnostic platform providers. For over 10 years, the company has developed an exceptional reputation among both industry and FDA regulatory leaders.

Services Overview

MMD provides a unique offering that spans the drug development continuum from biomarker discovery to companion diagnostic commercialization. Assay design, development, and commercialization of a diagnostic test requires a different skill set and tool box and is often an unmet need of our Biopharma clients. It is not uncommon for a diagnostic assay to evolve over the course of the co-development process and it is critical to proactively manage changes that may occur throughout the continuum of the clinical trial. Deploying a comprehensive bridging strategy is an important risk mitigator to account for the fact that therapeutic and diagnostic timelines do not always line up. Aligning with a co-development partner possessing sufficient bridging and assay migration capabilities is critical to the success of the therapeutic program. MMD leverages its scientific and technological expertise to mitigate and manage the risks of assay development, clinical trial assay design and, where required, regulatory submission of a companion diagnostic assay/system which is approvable by the FDA; all accomplished within an agreed upon timeline.

MolecularMD’s Core Competencies

We deliver value to our Biopharma clients through four principal segments:

  • Advanced Diagnostics
  • CTA & IVD Development
  • Centralized Testing Services
  • cGMP Manufacturing

MMD’s core business is focused around the Centralized Clinical Testing Services and Clinical Trial Assay and IVD Development segments, while the Advanced Diagnostics and Manufacturing and Commercialization segments have been built out to support the ongoing needs of our Biopharma clients.