Drug Response; Therapeutic management

Pharmacogenomics testing to assess how a patient may respond to prescribed drugs was performed by massively parallel Next Generation Sequencing (NGS). PGxOne™ Plus was developed, and assessed for accuracy and precision by Admera Health, South Plainfield NJ. The sensitivity and specificity of this test are 100% and 100% respectively. The … Pharmacogenomics testing to assess how a patient may respond to prescribed drugs was performed by massively parallel Next Generation Sequencing (NGS). PGxOne™ Plus was developed, and assessed for accuracy and precision by Admera Health, South Plainfield NJ. The sensitivity and specificity of this test are 100% and 100% respectively. The PGxOne™ Plus test is used for clinical purposes. It should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical laboratory testing. The DNA testing is not a substitute for clinical monitoring. View more

Guidance for selecting a drug therapy and/or dose

Patients taking or expecting to take medications included on the PGx One™ Plus test. See Conditions/Phenotypes section. Patients diagnosed with a condition in the therapeutic areas included in the PGxOne™ Plus test. See the Conditions/Phenotypes section.

Is research allowed on the sample after clinical testing is complete? Help
Not Applicable

Next-generation sequencing is used for confirmation of novel alleles.

Sanger Sequencing and qPCR are used to confirm novel alleles detected via Next-Generation Sequencing.

Tests performed
Entire test performed in-house

Genomic DNA samples purchased from Coriell institute or extracted from various types of specimen collected from anonymized donors were used. The NGS results were compared for concordance with bi-directional Sanger sequencing and qPCR results to indicate 100% concordance.

Admera Health’s PGxOne™ Plus test has an accuracy rating of > 99% specificity and sensitivity. PGxOne™ Plus currently does not detect hybrid alleles. A normal (negative) genotype signifies the absence of assay-specific alleles and does not indicate the absence of other mutations not covered by the assay. The possibility cannot … Admera Health’s PGxOne™ Plus test has an accuracy rating of > 99% specificity and sensitivity. PGxOne™ Plus currently does not detect hybrid alleles. A normal (negative) genotype signifies the absence of assay-specific alleles and does not indicate the absence of other mutations not covered by the assay. The possibility cannot be ruled out that the indicated genotypes may be present but below the limits of detection for this assay. View more

Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Formal PT program

PT Provider: Help
American College of Medical Genetics / College of American Pathologists, ACMG/CAP

Description of PT method: Help
We take Proficiency testing twice a year from CAP. Each time we received three genomic DNA samples and processed them as patient samples. Our PT pass rate for PGx is 100%.

Description of internal test validation method: Help
The PGxOne™ Plus tests were analytically validated using reference materials recommended by CDC and purchased from Coriell Institute and the sample collected from anonymized donors. Sensitivity, specificity, accuracy, and precision were evaluated by comparing NGS assay results to other standard genotyping methods, such as Sanger sequencing and qPCR.

Laboratory's policy on reporting novel variations Help
Not Applicable