Why Partner with Biodesix?

We are your dedicated partner and versatile diagnostic service provider with multi-omic expertise, a track record of successful collaboration with industry leaders, and an unwavering dedication to diagnostic innovation. Biodesix has two highly accredited laboratories which are in the top 1% of certified clinical labs in the US.

CAP-accredited check-icon
CLIA-certified check-icon
NYS CLEP-approved check-icon
ISO 13485-certified check-icon
2 EU IVDR CE marked medical devices check-icon
FDA CGMP manufacturing facility check-icon

We can leverage our technical expertise in assay design and development to ensure you have high performing tests to support your targeted therapy.

  • Best in Class Clinical Laboratories - Top 1% of Certified Labs in the US
  • Experienced Team - Some Team Credentials Include: MD, PhD, MS, BSc, CMQ/OE, CQA, CPQA
  • Multi-Omic Expertise and Capabilities - Molecular and Proteomic Expertise; Access to Multiple Technology Platforms
  • Industry Leading Turnaround Time - Critical for Prospective Trial Enrollment and Timely, Actionable Results
  • Kit Management - Sample Collection Kit Assembly, Kit Supply, Kit Tracking and Return Logistics

Biodesix is a reliable business partner and offers you operational efficiency. We recognize that time and resources are valuable, which is why we strive to customize each project based on your customer needs and the required regulatory pathway. We are flexible, reliable, timely, and tailor our services to each customers’ project specific requirement.

You can be confident partnering with our team – and we will help through every step of the way!

Together we can develop the best biomarker, testing and regulatory strategy to support your project.

  • Define the biomarker (genes, proteins, etc.)
  • Define the analyte (DNA, RNA, protein)
  • Select the sample type (serum, plasma, tissue, urine, cells, etc.)
  • Select the optimal technology (ddPCR, NGS, LC-MS/MS, MALDI-MS, ELISA
  • Guide through the Regulatory requirements
  • Guide through the Product Development Process

ddPCR is a trademark of Bio-Rad Laboratories, Inc.
CAP: College of American Pathologists
CLIA: Clinical Laboratory Improvement Amendments
NYS CLEP: New York State Clinical Laboratory Evaluation Program
ISO: International Organization for Standardization
cGMP: Current Good Manufacturing Practice