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Method Comparison Study of the Spartan FRX CYP2C19 Genotyping System Against Bi-directional Sequencing

NCT01718535 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 327

Last updated 2013-08-28

Study results available
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Summary

The Spartan FRX CYP2C19 Test System (hereafter referred to as the 'FRX System') is a qualitative in vitro diagnostic test for the identification of a patient's CYP2C19 \*2, \*3 and \*17 genotypes from genomic DNA obtained from buccal swab samples. This study is purposed to demonstrate the concordance (positive and negative percent agreement) by comparing the Spartan FRX system against bi-directional DNA sequencing. The study will also evaluate the concordance between three different sample transport embodiments provided to laboratories for use in transporting the reagent tubes with collected buccal sample swab to the laboratory.

Conditions

  • Genotyping Techniques

Interventions

DEVICE

Spartan FRX CYP2C19 Test System

Sponsors & Collaborators

  • Mount Sinai Hospital, Canada

    collaborator OTHER

  • Spartan Bioscience Inc.

    lead INDUSTRY

Principal Investigators

  • Azar Azad, PhD · Mount Sinai Hospital, Canada

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2012-11-30
Completion
2012-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01718535 on ClinicalTrials.gov