Biopharma Services

Biopharma Services

Biomarker testing services across the drug development continuum

Biodesix provides genomic and proteomic testing, custom assay development, and clinical trial support for pharmaceutical and biotechnology companies.

Scientific collaboration. Custom development. Agile execution.

We work closely with sponsors to help shape biomarker strategies, develop fit-for-purpose assays, and support project execution.

Discovery
Translational
IND-Enabling
Clinical Development
Regulatory Support
Certifications:CAP-AccreditedCLIA-CertifiedNYS CLEP-ApprovedISO 13485-Certified

Capabilities built around your program

From biomarker discovery and longitudinal monitoring, to fit-for-purpose assay development, and clinical trial testing support, our teams bring the scientific and operational expertise to support your program as it advances.

Genomic Testing
& Monitoring

Cost-effective longitudinal research with Droplet Digital™ PCR.

Ultra-low LOD as low as 0.02%, absolute quantification, and rapid turn-around time with pre-validated and custom assays available.

Broad panel genomic profiling with Next Generation Sequencing (NGS)

Pre-validated assays spanning from targeted to comprehensive panels for solid tumors and hematological malignancies.

Droplet Digital and ddPCR are trademarks of Bio-Rad Laboratories, Inc.

Discovery & Targeted
Proteomics

Discovery biology to identify protein biomarkers

Unbiased, high-depth proteomics to uncover mechanism-of-action and pharmacodynamic biomarkers.

Targeted monitoring of proteins of interest

Longitudinal protein measurement to support biomarker validation and patient stratification.

Spatial Proteomics with MALDI-IHC

Protein expression mapping and drug distribution directly within tissue architecture to link molecular mechanisms with histopathology.

Custom Assay Development

Custom panels built for your clinical program. We design testing panels around each program's biology and endpoints, validated for clinical-trial use rather than repurposed from off-the-shelf research products.

*Multiplexed assays screen for the presence or absence of multiple mutations in a single sample. They can be discriminating or non-discriminating

Clinical Trial Support
& Sample Logistics

Biodesix has the infrastructure to support your project end to end. Our in-house FDA-registered manufacturing facility can customize collection kits to your program's needs that meet all regulatory requirements.

We partner with domestic and international central labs and clinical trial sites to facilitate the management and procurement of samples. Once samples arrive on site, our quality management system maintains the appropriate chain of custody for all samples and associated data.

Supporting your Program's needs:

  • FDA-registered manufacturing facility
  • Collection Kit design
  • Partnerships with central labs and trial sites
  • QMS sample management
  • Chain of Custody
  • Domestic/International Support
Ready to Partner?

Tell us about your program.

Share your indication, assay needs, and project phase. Our team will connect you with the right expertise and capabilities to move your program forward.