Evaluation of Primex's PGX Assay to Assess the Clinical Utility of Pharmacogenomics
Status unconfirmed
Conditions studied: Patients on Medications Metabolized Via CYP450
In brief
Primex's PGX assay is an in vitro, semi automated assay, intended for the determination of certain genes involved in drug metabolism utilizing buccal swabs. Detection of certain genotypes is used as an aid in the selection of appropriate medications based on the individuals' specific genotype and should be used in conjunction with other clinical information. The results from this tests constitutes one parameter in a multicriterion medication selection process, encompassing both clinical and laboratory-based assessments.
Key facts
- Study ID
- NCT02336269
- Run by
- Primex Clinical Laboratories, Inc.
- People needed
- 100000
- Starts
- 2013-10-01
- Expected to finish
- 2019-10-01
- Last updated by the study team
- 2015-01-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Buccal swab sample prospectively collected under Informed Consent
- Remnant Buccal swab sample meeting the FDA requirements for use of leftover specimen
- Samples from at least one of the following groups:
- specimens from subjects who are on multiple medications of which at least 2 are affected by the pathways tested and the physician made changed to their drug regimen based on the assay interpretations
- subjects who are on multiple medications of which at least 2 are affected by the pathways tested and the physician made no changes based on the assay interpretations
- Subjects with Chronic disease
- Subjects with different ethnic backgrounds
- Subjects from different geographical areas
- Apparently healthy subjects
- Clinical information required per CRF is available
You may not qualify if…
- Samples that do not meet all inclusion criteria
Where it is running
- Research and Development Institute — Van Nuys, California, United States (enrolling)
Full record on ClinicalTrials.gov
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