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Diagnomics IRB

Diagnomics Research & Institutional Review Board (IRB)

Diagnomics is committed to advancing human health through innovative genomic, epigenetic, and precision medicine research. Our research activities are conducted under an Institutional Review Board (IRB)-approved framework designed to support a broad range of human genetics and health-related studies while ensuring the highest standards of participant protection, privacy, and ethical oversight.

Our research program enables the collection and analysis of biological specimens and genomic data to support scientific discovery, technology development, clinical validation, publication, and intellectual property generation.


  • Name of Sponsor Company: Diagnomics Inc.
  • Protocol Number and Title of Study: DR_CPLX_001; “Comparison study of genetic predisposition and prediction for diseases and traits by the analysis of individual genome using different computational algorithms”
  • Name of Person in Charge of the Research Study
  • (Study Doctor/Investigator): Min Seob Lee, Ph.D.

 

Diagnomics utilizes the Advarra IRB framework and CIRBI® (Center for IRB Intelligence) electronic research management platform to support the ethical review, regulatory oversight, and administration of human subject research. Advarra is one of the leading independent Institutional Review Boards (IRBs) in the United States, recognized for its expertise in protecting research participants and ensuring compliance with applicable regulatory and ethical standards.

Through this infrastructure, Diagnomics is able to efficiently support a broad range of research activities, including genomics, epigenetics, liquid biopsy, precision medicine, biomarker discovery, assay development, and translational research programs. The platform facilitates study submission, protocol review, investigator management, informed consent documentation, amendments, continuing review, and study closure within a secure and compliant environment.

The Advarra IRB framework also enables Diagnomics to collaborate with academic institutions, hospitals, clinical laboratories, biotechnology companies, and industry partners in both domestic and international research settings. This capability supports multi-site and cross-border studies involving human specimens, genomic data, and emerging precision medicine technologies.

By leveraging Advarra's accredited IRB infrastructure and internationally recognized human research protection standards, Diagnomics is committed to conducting research with the highest levels of scientific integrity, participant protection, ethical responsibility, and regulatory compliance.


Broad Research Scope

The Diagnomics IRB framework supports a wide variety of research areas, including:

  • Human genetics and genomics
  • Epigenetics and biological aging research
  • Cancer genomics and methylation studies
  • Liquid biopsy and molecular diagnostics
  • Precision medicine and personalized healthcare
  • Population genetics and ancestry studies
  • Multi-omics research
  • AI-driven genomic and health data analytics
  • Biomarker discovery and validation
  • Development and validation of laboratory-developed tests (LDTs)

The IRB allows the use of blood, saliva, buccal swab, and other human biological specimens for research purposes under approved protocols and informed consent procedures.


Collaborative Research Platform

Diagnomics actively collaborates with:

  • Universities and academic medical centers
  • Hospitals and healthcare systems
  • Biotechnology and pharmaceutical companies
  • Diagnostic laboratories
  • Government and public health institutions
  • International research organizations

Our IRB framework is designed to facilitate collaborative and multi-site research projects, including international studies involving third-party research partners. This allows collaborators to leverage Diagnomics' expertise, laboratory capabilities, genomic databases, and bioinformatics resources while maintaining regulatory and ethical compliance.


Supporting Scientific Innovation

Research conducted under the Diagnomics IRB framework may support:

  • Scientific publications
  • Patent development and intellectual property generation
  • Biomarker discovery programs
  • Product development and analytical validation
  • Clinical utility studies
  • CLIA laboratory test validation
  • Regulatory submissions and supporting scientific evidence packages


Ethical Oversight and Data Protection

Diagnomics maintains strict standards for participant privacy, data security, and specimen management. Research data are de-identified whenever appropriate and managed in accordance with applicable regulatory and ethical requirements. All studies undergo appropriate review to ensure the protection of research participants and the responsible use of genomic information.


Partner With Diagnomics Lab

We welcome opportunities to collaborate with organizations seeking to advance genomic science, precision medicine, longevity research, molecular diagnostics, and AI-powered healthcare solutions.

Whether your organization requires specimen collection, genomic analysis, biomarker validation, clinical research support, or international collaborative studies, Diagnomics provides an experienced research platform capable of supporting projects from early discovery through translational development.

For research collaboration inquiries, please contact Diagnomics Lab at:


info@diagnomics.com
www.diagnomics.com

Diagnomics IRB (pdf)Download
Research Informed Consent (pdf)Download

Diagnomics IRB

Your Partner in Genomic Research

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