Clinical Sample Testing

Together we can create, develop, and validate custom assays to be used for your clinical trial sample needs. We offer custom assays to full-scale GxP and CLIA & NYS CLEP validation.

  • Lab Certifications: CLIA, CAP, NYS CLEP, and ISO 13485 certifications
  • Best in Class Laboratory and Certifications and Rigorous Validation Process: With our CLIA/CAP/NYS CLEP/ISO 13485-certified laboratory, we offer RUO assay verification and analytical and clinical validation services for all assays, ensuring the highest standards of accuracy and quality.
  • Our company practices compliance and follow good practices (GxP)
    • cGMP, cGCP, cGLP, and GDP
  • QMS Systems: We maintain a leading Quality Management System, implementing measurement, analysis, and continuous improvement systems to reach the highest level of Quality; giving our pharma partners supreme confidence in the integrity of our testing results and confidence in the value of our robust data packages in submission to Regulatory bodies.
  • Fast turnaround time (3-5 business days from sample receipt)
  • Dedicated LIMS Systems: Our LIMS is designed to streamline laboratory operations, handling tasks from sample and test pairing to result capture and result reporting.

Biodesix has developed long-term compliance strategies ensuring full compliance to FDA's new QMSR in advance of the enforcement date, effective February 2nd, 2026.

Prospective or Batched Clinical Sample Testing - Quick turnaround with high quality.

We can test samples as they’re collected – just send to us and we can test and result quickly. We offer 3-5 business days for our ddPCR™ testing capabilities and 5-7 business days for our NGS testing capabilities. We can also test large retrospective sample sets sent to us. Depending on batch size, we can typically turn results around in 3-4 weeks.
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Tailored Solutions - Together we can develop the best biomarker, testing and regulatory strategy to support your targeted therapy.

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Our Genomic and Proteomic expertise and capabilities allows for the interrogation of genetic mutations (disease driving and emergence of resistance mutations), the ability to track changes in protein expression, profile a patient’s immune response, assess therapeutic efficacy, and conduct PK/PD analysis.

ddPCR is a trademark of Bio-Rad Laboratories, Inc.
GxP: Good practice guidelines and regulations
CLIA: Clinical Laboratory Improvement Amendments
NYS CLEP: New York State Clinical Laboratory Evaluation Program
CAP: College of American Pathologists
ISO: International Organization for Standardization
RUO: Research use only		 cGMP: Current Good Manufacturing Practice
cGCP: Current Good Clinical Practice
cGLP: Current Good Laboratory Practice
GDP: Good Documentation Practice
LIMS: Laboratory Information Management System
QMSR: Quality Management System Regulation
PK/PD: Pharmacokinetic-Pharmacodynamic