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GTR Home > Tests > Gravity Pharmacogenetics Comprehensive Profile

Performance Characteristics



  • Entire test performed in-house

Analytical Validity


Analytical accuracy was determined by analyzing 42 specimens with known genetic results through either published references (29 specimens) or a previously validated clinical laboratory test (13 specimens). Precision studies consisted of 4 specimens being run two separate days by two separate clinical laboratory scientist each day for a total of 4 independent runs. All results were concordant. Analytical sensitivity was a DNA dilution series which showed a minimum input of 0.5 ng/uL of starting genomic DNA is needed. Analytical specificity looked at common interferents which could impact sample collection and DNA isolation (food, beverages, tobacco) and showed no impact on our assay.


  • Association of Molecular Pathologist. Molecular Diagnostics Assay Validation – September 2014 AMP White Paper

Assay Limitation(s)


Certain SNP assays had no minor alleled verified during the validations due to the minor allele fraction being 0.000231 or less. A list of these SNPs are available upon request.

Proficiency Testing (PT)

Is proficiency testing performed for this test? Help
Method used for proficiency testingHelp
Formal PT program
PT ProviderHelp
American College of Medical Genetics / College of American Pathologists, ACMG/CAP
PT Description
Formal CAP proficiency testing is conducted for any genes present on those surveys. All other genes undergo an alternative PT assessment semi-annually.

FDA Regulatory Clearances of the Test

FDA Category Designation
Not Applicable

New York State CLEP (NYS CLEP) Test Approval

NYS CLEP test approval #

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