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GTR Home > Tests > NeurodevelopmentNext-Expanded™

Performance Characteristics

Availability

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  • Entire test performed in-house

Analytical Validity

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This test is designed and validated to be capable of detecting >95% of the exome covered with a minimum depth of coveraged of 20X.

Citations

Not provided

Proficiency Testing (PT)

Is proficiency testing performed for this test? Help
Yes
Method used for proficiency testingHelp
Formal PT program
PT ProviderHelp
American College of Medical Genetics / College of American Pathologists, ACMG/CAP

FDA Regulatory Clearances of the Test

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FDA Category Designation
FDA exercises enforcement discretion

New York State CLEP (NYS CLEP) Test Approval

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NYS CLEP test approval #
51096
Status
Approved

Clinical resources

Practice guidelines

  • ACMG, 2016
    Recommendations for reporting of secondary findings in clinical exome and genome sequencing, 2016 update (ACMG SF v2.0): a policy statement of the American College of Medical Genetics and Genomics.
  • ASHG/ACMG, 2015
    Points to Consider: Ethical, Legal, and Psychosocial Implications of Genetic Testing in Children and Adolescents
  • ACMG, 2015
    Clinical utility of genetic and genomic services: a position statement of the American College of Medical Genetics and Genomics.
  • ACMG, 2015
    Standards and guidelines for the interpretation of sequence variants: a joint consensus recommendation of the American College of Medical Genetics and Genomics and the Association for Molecular Pathology.
  • ACMG, 2013
    ACMG recommendations for reporting of incidental findings in clinical exome and genome sequencing.

Consumer resources

IMPORTANT NOTE: NIH does not independently verify information submitted to the GTR; it relies on submitters to provide information that is accurate and not misleading. NIH makes no endorsements of tests or laboratories listed in the GTR. GTR is not a substitute for medical advice. Patients and consumers with specific questions about a genetic test should contact a health care provider or a genetics professional.