Oncology Drug Approval - Accelerated

Bridging the gap between biomarkers and In Vitro Companion Diagnostics

  • Tailored Platforms & Methods Our IVD and RUO platforms and methods interrogate aberrations and expression in DNA, RNA, and Protein extracted from both FFPE and plasma.
  • Clinical Biomarker Evaluation Our turn key multiplex panels and custom designed and validated targeted assays support early phase Proof of Concept and late stage pivotal trials.
  • Drug Diagnostic Co-development Our IVD design and development expertise is supported by a highly experienced regulatory team and a Quality Management System compliant with QSR, ISO 13485 and Part 11.
  • Global & Regional Commercialization We offer custom IVD/CE manufacturing and distribution solutions for global and regional commercialization strategies based on approved indications.
  • Tailored Platforms & Methods
  • Clinical Biomarker Evaluation
  • Drug Diagnostic Co-development
  • Global & Regional Commercialization

MolecularMD is an oncology molecular diagnostics company that bridges the gap between biomarkers and In Vitro Companion Diagnostic solutions to accelerate targeted therapy development and commercialization.

Backed by IVD fit for purpose development and commercialization expertise, we help drive breakthrough oncology therapies to market. And with our ability to rapidly adapt to changes, we can manage and mitigate risk no matter the uncertainty.

The result: MolecularMD – OncologyDx

MolecularMD discusses the clinical application of liquid biopsy or circulating tumor DNA (ctDNA) and its benefits within the field of oncology and companion diagnostics.