Oncology Biomarker Diagnostics

Linking molecular status to breakthroughs in cancer treatment

Assay Development

MolecularMD was founded to meet an emerging industry need for reliable, reproducible, standardized molecular testing services to support clinical development of new cancer therapies.  With rigorous scientific methods applied to the processes of assay development and validation, MolecularMD provides high quality biomarker diagnostics sought by pharmaceutical sponsors. 

Our commitment to quality extends throughout our entire organization. To achieve this level of excellence in assay development, we invest the extra effort it takes to meet our own standards and exceed those of the industry.  Whether the assay is based on MolecularMD’s 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. 

Our development capabilities include custom assay design based on partner preferences and practicalities related to the biomarker(s) being evaluated.  We employ a variety of molecular approaches, from traditional Sanger sequencing, IHC, RT-qPCR and allele-specific PCR to more recently developed technologies including droplet digital PCR and Next Generation Sequencing.  We remain platform agnostic, continuously evaluating new technology and instrumentation with the goal of providing the current platform options to meet the scope and data requirements our partners and regulatory agencies demand.  We strive to provide the technology options best suited to meet the needs for biomarker detection/quantification.

Our assays undergo rigorous analytical and clinical validation, following the specific 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.

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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