Clinical Laboratories Meeting Minimum Requirements for Data Sharing to Support Quality Assurance

ClinGen considers the sharing of variant interpretations essential for supporting genomic medicine and a critical part of quality assurance for accurate genetic and genomic testing. Open and transparent sharing allows peer-review and knowledge dissemination to ensure the highest quality care of patients. 

Here, we identify clinical laboratories who meet a minimum standard of data sharing:

  • Laboratory submissions are registered in ClinVar as ‘Single Submitter, Assertion criteria provided’ (single star)
  • A complete list of the laboratory’s test offerings are publicly available either through a registry such as Genetic Test Registry (GTR) or Orphanet or on the laboratory’s website (Requirement modified February 2019 to any public display of the laboratory's complete list of test offerings, not limited to GTR)
  • Laboratory submits at least once per year adding new variants and updating reclassified variants as necessary
  • Laboratory submits all categories of variants reported to patients (labs are also encouraged to share B/LB variants and VUS if not reported)
  • Laboratory has attested to submitting at least 75% of all sequence and/or copy number variants reported in the past year
  • Laboratory has submitted at least 100 variants
  • Laboratory is CLIA certified laboratory (USA) or meets an equivalent standard in another country

To apply for status, or to update your status, laboratories can apply here.

Please note, changes to minimum requirements will go into effect January 1, 2020. Review revised requirements here.

Questions about the criteria? Visit our Frequently Asked Questions or contact

Click here to see patient registries that share data. 

Laboratory Meets  requirements Additional Achievements
Submitted evidence1 >75% from past 5 years2 Discrepancy resolution3 Consenting mechanism4


Athena Diagnostics Inc.

Centre for Mendelian Genomics, University Medical Centre Ljubljana 

Center for Pediatric Genomic Medicine, Children's Mercy Hospital and Clinics    
Color Genomics, Inc.


EGL Genetics (Emory)


GeneKor MSA    


Integrated Genetics/Laboratory Corporation of America    

Partners Laboratory for Molecular Medicine

Phosphorus Diagnostics LLC

Quest Diagnostics Nichols Institute San Juan Capistrano

University of Chicago


Some requirements and additional achievements based on self-reported data by laboratory

Most recent submission pending ClinVar processing
1 Majority of submissions have evidence submitted (excludes allele-frequency classified variation)
>75% of classified sequence and/or copy number variants from past 5 years submitted
3 Actively working to resolve interlab interpretation differences
4 Laboratory actively supports use of a consenting mechanism to enable patients to directly consent to share detailed, individual-level clinical data (e.g., an internal patient registry made available for collaborative research, or report language highlighting external registries such as GenomeConnect)