Gravity Pharmacogenetics Comprehensive Profile
- GTR Test IDHelpEach Test is a specific, orderable test from a particular laboratory, and is assigned a unique GTR accession number. The format is GTR00000001.1, with a leading prefix 'GTR' followed by 8 digits, a period, then 1 or more digits representing the version. When a laboratory updates a registered test, a new version number is assigned.: GTR000604268.2
- Last updated: 2023-04-10
- Test version history
Clinical testHelpIn the U.S., clinical tests must be performed under CLIA certification. When a lab uses the same methods for a test in both clinical and research settings, the test appears as two separate GTR records. for Selective serotonin reuptake inhibitor response
Offered by Gravity Diagnostics
Methodology
Methodology
HelpThe assay's major method category (biochemical, cytogenetic or molecular genetics); method category (i.e. enzyme assay, chromosome breakage studies, targeted mutation analysis); methodology (i.e. the name of the method used) and instruments used when performing this test.- Molecular Genetics
- TTargeted variant analysis
- Allele-specific primer extension (ASPE)
- Agena Biosciences MassARRAY
- Agena Biosciences MassARRAY
Test development
HelpHow the test was developed (e.g. Laboratory Developed Test (LDT), FDA reviewed, externally manufactured kit, modified FDA-reviewed test, or combination). Intended to help differentiate certification requirements between the test types. Reflex testing not included here.Test developed by laboratory (no manufacturer test name)
Test procedure
HelpSummary of the test methodology and/ or description of the specific steps for each method used in this assay.Brief, DNA is isolated from buccal swabs followed up multiple PCR reaction to amplify regions containing functionally defined SNPs. The amplification reactions are treated with phosphatase and a single base extension reaction is conducted with the oligonucleotide adjacent to the SNP of interest. The reaction is desalted and then subjected to MADI-TOF mass spectrometry to determine the molecular mass of the extended oligonucleotide. The size of that product would determine the base added and thus the patients variant at that location. Each SNP is compiled into determining the potential functional output of the gene analyzed.
- Development and Analytical Validation of a 29 Gene Clinical Pharmacogenetic Genotyping Panel: Multi-Ethnic Allele and Copy Number Variant Detection. - PubMed ID: 32931151
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