Spartan Cube CYP2C19 Method Comparison Study

Spartan Bioscience

Status: Completed

Conditions: Genotyping Techniques

Treatments: Device: Spartan Cube CYP2C19 System

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04473586

VNV-00229

Details and patient eligibility

About

The aim of the study is to demonstrate concordance (percent agreement) between results produced by the Spartan CYP2C19 system and bi-directional sequencing. In addition, this study will evaluate the concordance of buccal samples stored prior to running on the Spartan Cube CYP2C19 system and bi-directional sequencing.

Full description

Sample holding time - two parts

1. Sample tested in less than one-hour

   a.In the first part, buccal samples will be collected from subjects and tested using the Spartan Cube CYP2C19 system. These samples will be run immediately (within 1 h) after collection from the subject (<1 h sample holding time). All results will be compared to bi-directional sequencing to determine percent agreement.

2. Sample tested greater than 21 hours a.In the second part (sample holding portion), samples will be tested using the Spartan Cube CYP2C19 product. These samples will be run after storage at ambient temperature. All results will be compared to bi-directional sequencing to determine the percent agreement.

Enrollment: 425 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants who will provide buccal samples and a saliva sample who have not eaten drank or smoked in the past 30 minutes.

Exclusion criteria

• Participants who have eaten drank or smoked in the past 30 minutes prior to collection.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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425 participants in 2 patient groups

Sample tested in less than one-hour

Other group

Description:

Buccal samples will be collected and analyzed on the Spartan Cube CYP2C19 System immediately (\<1hr). The Spartan Cube CYP2C19 results will be compared with bi-directional sequencing results generated by a third part from a saliva sample collected from the same subject.

Treatment:

Device: Spartan Cube CYP2C19 System

Samples tested greater than 24 hours

Other group

Description:

Buccal samples will be collected, stored and then analyzed on the Spartan Cube CYP2C19 System greater than 24 hours after collection. The Spartan Cube CYP2C19 results will be compared with bi-directional sequencing results generated by a third part from a saliva sample collected from the same subject.

Treatment:

Device: Spartan Cube CYP2C19 System