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GTR Home > Tests > Variant Resolution Test for CancerNext® (+RNAinsight®)

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 ~99% of described mutations in the gene(s) represented.

Citations

Not provided

Proficiency Testing (PT)

Is proficiency testing performed for this test? Help
No

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 #
73884
Status
Approved

Suggested reading

Practice guidelines

  • NCCN, 2023
    NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Colon Cancer, 2023
  • ACMG ACT, 2019
    American College of Medical Genetics and Genomics, Genomic Testing (Secondary Findings) ACT Sheet, APC Pathogenic Variants (Familial Adenomatous Polyposis [FAP]), 2019
  • ACMG ACT, 2012
    American College of Medical Genetics and Genomics Family History ACT Sheet, Colon Cancer (Asymptomatic), 2012
  • EuroGenetest, 2011
    Clinical utility gene card for: familial adenomatous polyposis (FAP) and attenuated FAP (AFAP).

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