Together, Helix and QIAGEN provide biopharma companies with a best-in-class global CDx solution

A single, global partnership that supports diagnostic assay development through all phases of clinical trial development and commercialization.

World class regulatory experience with proven ability to get CDx regulatory approvals with regulatory agencies in every market, including FDA and EMA

Innovative laboratory platform and assay that can accelerate many aspects of clinical trials in addition to germline CDx, such as patient recruitment and real world evidence studies

Leverage the Helix® Laboratory Platform with worldwide companion diagnostic (CDx) development capabilities from QIAGEN to expand critical access to genomic testing.


The HelixⓇ Laboratory Platform is the first and only whole exome sequencing platform authorized by the FDA. Whole exome sequencing enables CDx development across a range of hereditary diseases in all phases of a clinical trial. Helix will develop and commercialize single site premarket approval (PMA) companion diagnostics for the US, and all testing in the US is performed in Helix’s San Diego based CLIA / CAP next-generation sequencing lab.

What we do

Companion Diagnostics Development

  • Exome+Ⓡ assay optimized to cover a range of biomarkers for hereditary companion diagnostics
  • Preparation and submission of all validation studies and performance data to FDA
  • Direct engagement with FDA to coordinate submissions, answer questions, and resolve issues

Support All Phases of Clinical Trials

  • The Helix Laboratory Platform and Exome+Ⓡ sequencing support the entire clinical trial process from initial clinical trials through companion diagnostic approval
  • Support companion diagnostics in a range of hereditary (germline) therapeutic areas, including:
    • Cardiovascular 
    • Neurology
    • Immunology
    • Metabolic disorders

Commercial Readiness

  • Helix's CAP / CLIA lab can immediately launch commercial testing of the approved CDx in the US
  • Robust market access capabilities to ensure immediate access for all patients
  • Leverage Helix national health system partners for day one readiness
     

“The partnership represents a significant step forward bringing the power of companion diagnostics to hereditary disease. QIAGEN’s extensive pharma and biopharma relationships and global regulatory expertise along with Helix’s Exome+ assay and innovative health system partnerships provide biopharma companies with a single solution that can address many of the challenges in drug development and clinical trials.”

Thierry Bernard

Chief Executive Officer of QIAGEN

Get in touch

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