Drug Response; Therapeutic management

Guidance for selecting a drug therapy and/or dose

Patients having never received a pharmacogenomic test for determining potential response to various psychotropic medications. Patients suffering from refractory moderate to severe depression. Patients having previously tried and failed at least one prior neuropsychiatric medication. Ordering physician certifies that they have psychiatry or neuropsychiatry boards, and is eligible to order … Patients having never received a pharmacogenomic test for determining potential response to various psychotropic medications. Patients suffering from refractory moderate to severe depression. Patients having previously tried and failed at least one prior neuropsychiatric medication. Ordering physician certifies that they have psychiatry or neuropsychiatry boards, and is eligible to order this test for their patient. View more

Is research allowed on the sample after clinical testing is complete? Help
Yes

The nP assay interrogates variants in 13 pharmacogenomic genes from DNA isolated from buccal swabs or saliva. The assay interrogates SNVs, small indels, the SLC6A4 5-HTTLPR promoter variant and CYP2D6 CNVs. SNVs and small indels are detected using MALDI-TOF, and the SLC6A4 5-HTTLPR promoter variant and CYP2D6 CNVs are detected … The nP assay interrogates variants in 13 pharmacogenomic genes from DNA isolated from buccal swabs or saliva. The assay interrogates SNVs, small indels, the SLC6A4 5-HTTLPR promoter variant and CYP2D6 CNVs. SNVs and small indels are detected using MALDI-TOF, and the SLC6A4 5-HTTLPR promoter variant and CYP2D6 CNVs are detected via fragment analysis. The Tempus nP gene panel has been designed to specifically target genes known in the literature to be linked with metabolism, response, and risk for adverse events to psychotropic medications. View more

PCR amplification and fragment analysis for CYP2D6 CNVs and SLC6

Tests performed
Entire test performed in-house

The Tempus nP assay is validated for reporting of clinically important variants in 13 genes with known roles in pharmacodynamics, pharmacokinetics, and immune responses to certain medications. The test is validated for use with DNA isolated from patient buccal swabs and saliva samples. SNVs and small indels are detected using … The Tempus nP assay is validated for reporting of clinically important variants in 13 genes with known roles in pharmacodynamics, pharmacokinetics, and immune responses to certain medications. The test is validated for use with DNA isolated from patient buccal swabs and saliva samples. SNVs and small indels are detected using MALDI-TOF, and the SLC6A4 5-HTTLPR promoter variant and CYP2D6 CNVs are detected via fragment analysis. Performance characteristics for sensitivity and specificity were calculated in accordance with CAP/CLIA guidelines and regulations. Extracted DNA from The Coriell Institute with corresponding reference and variant/allele calls in the 1000 genomes data-set or the Genetic Testing Reference Material Coordination Program (GeT-RM) as well as residual patient DNAs tested on an orthogonal method were used for calculations. Sensitivity and specificity for all variants types was greater than 99%. View more

The analysis of nucleic acids by MALDI-TOF and fragment analysis can be affected by multiple factors including sample collection integrity and DNA quality. Additionally, the chance of detecting genetic alterations may be reduced in regions of the genome that are structurally difficult to sequence, in homologous genes, or due to … The analysis of nucleic acids by MALDI-TOF and fragment analysis can be affected by multiple factors including sample collection integrity and DNA quality. Additionally, the chance of detecting genetic alterations may be reduced in regions of the genome that are structurally difficult to sequence, in homologous genes, or due to sequencing errors. CYP2D6 copy number gain in the presence of a deletion may not be detected. The HLA-A variant rs1061235 detects HLA-A*31:01, but also may detect certain HLA-A*33 haplotypes. View more

Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Formal PT program

PT Provider: Help
College of American Pathologists, CAP

CAP Testing Information Help
Pharmacogenetics; CYP2B6; PGX
Pharmacogenetics; CYP2C19; PGX
Pharmacogenetics; CYP2C9; PGX
Pharmacogenetics; CYP2D6; PGX
Pharmacogenetics; CYP3A4; PGX
Pharmacogenetics; CYP3A5; PGX

Software used to interpret novel variations Help
N/A

Laboratory's policy on reporting novel variations Help
N/A