Corgenix

A CAP/CLIA-accredited, high-complexity laboratory delivering mass spectrometry–based insights to support patient care, clinical decision-making, and translational research. Corgenix
our mission

Clinical Laboratory Services
to improve patient outcomes

Corgenix provides advanced clinical laboratory services focused on improving patient outcomes through high-complexity diagnostic testing.
Located outside Denver, Colorado, Corgenix is a CAP-accredited and CLIA-licensed clinical laboratory and part of the Sebia Group. Our expertise in proteomics and mass spectrometry enables us to deliver precise, actionable insights that support clinicians, patients, and biopharmaceutical partners in disease management, clinical trials, and personalized medicine.

Clinical Laboratory

High-Complexity Testing for Precision Medicine

Our CAP-accredited and CLIA-licensed laboratory delivers high-complexity testing solutions designed to support the diagnosis, monitoring, and management of complex diseases—particularly in oncology (including multiple myeloma), autoimmune disorders, and rare conditions. Leveraging deep expertise in protein analysis and mass spectrometry, we provide highly sensitive and specific assays that enable clinicians to make informed treatment decisions and improve patient outcomes.

Actionable Insights for Better Care

We support clinicians with reliable, high-quality diagnostic data to inform treatment strategies and ongoing disease management.

 

Our testing capabilities are designed to:

– Enable earlier and more accurate detection of disease relapse

– Monitor disease progression and depth of treatment response

– Support personalized therapeutic decision-making

Clearer Insights. Better Disease Management.

We provide advanced, minimally invasive testing that enables more frequent and informative monitoring of disease.

 

Our approach supports:

– Blood-based monitoring of minimal residual disease (MRD)

– More frequent testing to track disease status over time

– Improved visibility into treatment effectiveness

 

By delivering precise and consistent results, we help clinicians better guide each patient’s treatment journey and improve overall outcomes.

Enabling Clinical Trials and Translational Research

Corgenix Clinical Laboratory is a trusted partner to pharmaceutical and biotechnology companies, delivering high-quality laboratory solutions that accelerate clinical development and drive regulatory success.

 

M-inSight® provides a powerful, minimally invasive approach to monitoring treatment response in multiple myeloma. By using peripheral blood instead of bone marrow, M-inSight® enables more consistent sample collection, higher testing success rates, and the ability to longitudinally track both depth and kinetics of response across diverse patient populations—including newly diagnosed, relapsed/refractory, and extramedullary disease.

As the field continues to evolve, minimal residual disease (MRD) has become a critical biomarker for evaluating therapeutic efficacy. In April 2024, the FDA’s Oncologic Drugs Advisory Committee unanimously supported MRD-negative complete response as an early endpoint reasonably likely to predict clinical benefit—reinforcing MRD’s growing role in enabling accelerated approval pathways.

 

Corgenix supports:

– Clinical trials (Phase I–IV)

– Investigator-initiated studies

 

With deep expertise in proteomics and mass spectrometry, we deliver robust, reproducible data that empowers confident decision-making, strengthens regulatory submissions, and helps bring innovative therapies to patients faster.

QUALITY & COMPLIANCE

Built on a Foundation of Quality Assurance

Quality is embedded in every aspect of our laboratory operations. Our comprehensive Quality Management System ensures the highest standards of accuracy, reliability, and regulatory compliance.
All samples are managed through a validated Laboratory Information Management System (LIMS), ensuring full traceability, data integrity, and operational efficiency.
 
Accreditations & Standards:
  • CAP-accredited laboratory
  • CLIA-certified for high-complexity testing
  • RI licensed
  • PA licensed
  • CA licensed
  • ISO 13485-certified Quality Management System
  • Compliant with FDA Quality System Regulation (21 CFR Part 820)
 
Our Quality Commitment:
  • Strict adherence to regulatory and accreditation standards
  • Continuous quality improvement and process optimization
  • Delivery of reliable, reproducible results you can trust

Corgenix is a CAP-accredited and CLIA-licensed clinical laboratory