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GTR Home > Tests > Hereditary Gastric Cancer Panel

Performance Characteristics

Availability

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  • Entire test performed in-house

Analytical Validity

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Control samples with over 1000 known variants were used to establish analytical validity. Analytical validity of > 99.99% was achieved.

Citations

Not provided

Assay Limitation(s)

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10 ng of purified DNA

Internal Test Validation Method

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Following CLIA guidelines

Citations

Not provided

Proficiency Testing (PT)

Is proficiency testing performed for this test? Help
Yes
Method used for proficiency testingHelp
Inter-Laboratory

FDA Regulatory Clearances of the Test

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FDA Category Designation
FDA exercises enforcement discretion

Clinical resources

Practice guidelines

  • EGTM, 2014
    Tumor markers in colorectal cancer, gastric cancer and gastrointestinal stromal cancers: European group on tumor markers 2014 guidelines update.
  • AHRQ, 2013
    Technology Assessment on Genetic Testing or Molecular Pathology Testing of Cancers with Unknown Primary Site to Determine Origin (ARCHIVED)

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.