ClinGen is a National Institutes of Health (NIH)-funded resource dedicated to building an authoritative central resource that defines the clinical relevance of genes and variants for use in precision medicine and research. Quest and Athena are two of 12 laboratories on the list identified by ClinGen as meeting ClinGen’s minimum requirements for data sharing to support quality assurance.
There are multiple requirements for inclusion on the ClinGen list including the following. The lab must:
- Ensure submissions are registered in ClinVar as ‘Single Submitter, Assertion criteria provided’ (single star)
- Be registered in the Genetic Test Registry (GTR) with up-to-date yearly review (an NIH database that the public can reference for information about the clinical evidence underlying marketed tests)
- Submit at least once per year adding new variants and updating reclassified variants as necessary
- Submit all categories of variants returned to patients
- Attest to submitting at least 75% of all sequence variants reported in the past year
- Submit at least 100 variants
- Be CLIA certified laboratory in the USA
As the world’s leading diagnostic information services company, we are proud to be recognized as leaders in contributing quality data to advance patient care. Meeting data sharing requirements is a testament to our dedication to empowering better health through diagnostic insights.
Quest Diagnostics Nichols Institute focuses on specialized and highly complex laboratory testing, such as advanced diagnostics and plays a key role in Quest Diagnostics research and development efforts. Performing tests rarely done in most routine or hospital laboratories, Nichols Institute has deep expertise in a range of subspecialties including cancer, endocrinology, genetics/personalized medicine, infectious diseases and more.
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