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Biopharma Services

Your diagnostic partner

We provide biopharmaceutical companies with end-to-end diagnostic services inclusive of diagnostic research and feasibility, assay development, clinical trial testing, and commercialization of companion diagnostics.

Diagnostic Research & Feasability

To address the increasing complexity of disease biology and new drug mechanisms of action, we employ a blood-based, technology agnostic approach for diagnostic research to uncover novel insights about the tumor biology and patient’s immune response to cancer for biopharmaceutical therapeutics in clinical development. Our services support known biomarker feasibility as well as unbiased diagnostic research to discover novel biomarkers of interest.

Learn more about how we can support you with our diagnostic research and feasibility capabilities:

Diagnostic Research & Feasibility

Assay Development

We are proud to have two, highly-certified clinical diagnostic testing laboratories in the United States. Our Boulder, Colorado-based laboratory is CAP/CLIA/NYS CLEP/ISO 13485-approved and our De Soto, Kansas-based laboratory is CAP/COLA/NYS CLEP-approved.

We have an established product development process for our biopharmaceutical customers that is designed to be fit-for-purpose to specific project needs and allows for scalability. Development options range from basic research assay development through to a full product development process inclusive of design, development, transfer into regulatory labs, management within FDA-registrational prospective trials, and commercialization.

Clinical Trial Diagnostic Testing​

We have broad in-house capabilities to enable diagnostic testing to support your prospective clinical trials.

icon-talk Project & Data Management
icon-result-blue Lab Manual & Sample Collection Protocol
3Asset 29 Sample Collection Kit Development & Tracking
icon-it-system IT System Integration

Experienced in Blood-Based Diagnostic Commercialization

We believe we are the first company with four clinically available, reimbursed, diagnostic tests that address clinical questions across the lung cancer continuum of care. We have nationally-based clinical sales and medical affairs teams who are focused on working with physicians who diagnose and treat lung cancer. Additionally, we are experts in diagnostic reimbursement and have coverage in the United States for our lung focused diagnostics.

LEARN ABOUT OUR LUNG DIAGNOSTICS

Companion Diagnostic Partnering

We strive to hold ourselves to the highest quality standard so we can provide our biopharmaceutical customers with superior diagnostic solutions to overcome the challenges and risks associated with drug discovery, development, and commercialization through strategic companion diagnostic (CDx) partnering.

Our Approach to CDx Partnering

We believe partnering with us will help you:

  • Increase probability of success for pivotal trials with quicker enrollment rates
  • Identify patient populations that will experience the greatest benefit from new therapies
  • Realize greater efficiency in clinical development by predicting responses to therapy

Contact our biopharma services team to learn more about our capabilities to be your diagnostic partner

REACH OUT TO OUR TEAM