Oncology Drug Approval - Accelerated

Bridging the gap between biomarkers and In Vitro Companion Diagnostics

Assay Development

With rigorous scientific methods applied to the processes of assay development and validation, MolecularMD provides high quality biomarker diagnostics sought by pharmaceutical sponsors. 

Whether the assay is based on our expanding Intellectual Property portfolio, or an assay transferred to our team by one of our partners, we have the components in place for rapid assay development under current regulatory guidelines. 

We employ a variety of molecular approaches including:

  • Traditional Sanger sequencing
  • IHC
  • RT-qPCR
  • Allele-specific PCR
  • Droplet digital PCR
  • Next Generation Sequencing

Because we are platform agnostic, we are continuously evaluating new technologies and instrumentation with the goal of providing the most current and best platform options to meet the scope and data requirements for biomarker detection/quantification that our partners and regulatory agencies demand.

Our assays undergo rigorous analytical and clinical validation, following the regulatory guidelines set by AMP, CLIA/CAP, and the FDA.  We optimize assay conditions to achieve the highest degree of accuracy, specificity, sensitivity/LOD, reproducibility, input range and efficiency.  Each test is developed with appropriate controls that establish, monitor, and guarantee high quality data each and every run.

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




MolecularMD offers:

  • Selection of assay platforms and chemistries
  • Support of multiple specimen types
  • Rigorous analytical validation
  • Flexibility to customize assay parameters and reporting
  • Key intellectual property positions