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

This study has been completed.
Sponsor:
Collaborator:
Mount Sinai Hospital, Canada
Information provided by (Responsible Party):
Spartan Bioscience Inc.
ClinicalTrials.gov Identifier:
NCT01718535
First received: October 29, 2012
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Genotyping Techniques
Device: Spartan FRX CYP2C19 Test System

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Method Comparison Study of the Spartan FRX CYP2C19 *2, *3, and *17 Genotyping System

Further study details as provided by Spartan Bioscience Inc.:

Primary Outcome Measures:
  • Percent Agreement [ Time Frame: After second pass result is complete (~3hours) ] [ Designated as safety issue: No ]
    The study will pass if the percent agreement is ≥ 99.0% and the lower bound of a 1-sided 95% confidence interval is ≥ 95.0% using the score method.


Enrollment: 327
Study Start Date: September 2012
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CYP2C19 Genotyping Device: Spartan FRX CYP2C19 Test System

Detailed Description:

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.

The FRX system is comprised of hardware and consumable components. The hardware components of the system include an Analyzer (thermal cycler with fluorescence detection capability), a netbook computer and a printer. The consumable component of the FRX system is a sample collection kit. Each kit contains a buccal swab (used to collect the patient sample) and a tube containing the reagents required for genomic DNA extraction and PCR amplification stages of the test.

The Spartan FRX System is capable of detecting three CYP2C19 SNPs (*2, *3, *17) in each test performed. An individual sample collection kit is required for each SNP tested; therefore three sample collection kits are required for each test performed on the system.

The FRX System is to be used by trained personnel in CLIA certified laboratories and is for use with buccal samples collected directly from patients. The FRX CYP2C19 test is intended to enable clinicians to identify patients with mutations in the *2,*3 and *17 loci of the CYP2C19 gene and is indicated for use as an aid to clinicians in determining strategies for therapeutics that are metabolized by the CYP2C19 gene product.

To perform a test, the user collects three buccal samples from the patient and then inserts a sample into each of the three reagent tubes (one for each of the CYP2C19 loci *2, *3 and *17). The reagent tubes are placed into the Analyzer and the FRX system automates the processes of DNA extraction, PCR amplification, fluorescent signal detection and data analysis. The system provides the user with a printed result listing the patient genotypes at the *2, *3 and *17 loci.

This study has been designed 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.

For each mutation, agreement of the FRX System against bidirectional sequencing (comparative method) will be calculated: The overall accuracy of the test will be calculated and reported as follows:

  • of concordant results between the test and the reference method Accuracy = ----------------------------------------------------------------
  • of samples analyzed by the reference method

The first and second pass results from the study will be analyzed and tabulated as outlined in the table below. The acceptance criteria for the overall study will be percent in agreement ≥ 99.0% for the second pass with the lower bound of a one-sided 95% confidence interval using the score method ≥ 95.0%.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

320 Individuals with undetermined CYP2C19 *2 *3 and *17 Genotypes

Criteria

Exclusion Criteria:

None

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01718535

Locations
Canada, Ontario
Mount Sinai Services
Toronto, Ontario, Canada, M5G1Z5
Sponsors and Collaborators
Spartan Bioscience Inc.
Mount Sinai Hospital, Canada
Investigators
Principal Investigator: Azar Azad, PhD Mount Sinai Hospital, Canada
  More Information

No publications provided

Responsible Party: Spartan Bioscience Inc.
ClinicalTrials.gov Identifier: NCT01718535     History of Changes
Other Study ID Numbers: 01001679
Study First Received: October 29, 2012
Results First Received: February 7, 2013
Last Updated: May 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Spartan Bioscience Inc.:
Cyp2C19
Genotyping
Spartan
Comparison
Sequencing

ClinicalTrials.gov processed this record on August 18, 2014