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esensor warfarin sensitivity and xt-8 instrument
Osmetech Molecular Diagnostics
Summary: The eSensor Warfarin Sensitivity and XT-8 Instrument by Osmetech is used to genotype patients for warfarin sensitivity. It's primarily used by clinicians in pharmacogenomics to optimize warfarin dosing.
FDA Clearance Information
Pathway
510K
Number
K073720 ↗
Decision Date
July 17, 2008
Product Code
ODW
Device Class
Class 2
Evidence
0 studies
The eSensor Warfarin Sensitivity device, manufactured by Osmetech Molecular Diagnostics, received FDA clearance through the 510k pathway on July 17, 2008. It is a Class 2 device under product code ODW.
What It Is
The eSensor Warfarin Sensitivity and XT-8 Instrument is a molecular diagnostic tool designed to identify genetic variations in CYP2C9 and VKORC1 genes, which affect warfarin metabolism. By detecting these genetic markers, the device helps clinicians tailor warfarin dosing to individual patients, minimizing the risk of adverse drug reactions. The device operates using an electrochemical detection method to provide rapid and accurate genotyping results.
Clinical Applications
This device is commonly used in clinical settings where warfarin is prescribed, such as cardiology and hematology clinics. It is particularly valuable for patients initiating warfarin therapy, those with a history of unstable INR levels, or those with a family history of warfarin sensitivity. The device is typically utilized in outpatient settings, but it can also be used in hospitals where rapid genotyping is needed to adjust dosing in a timely manner.
Indications for Use
The FDA-cleared indications for this device involve genotyping patients for specific genetic markers that influence warfarin sensitivity. It is intended for use in patients who are being considered for warfarin therapy, allowing for personalized dosing strategies to reduce the risk of bleeding or thrombosis.
Practical Considerations
The eSensor Warfarin Sensitivity device is compatible with the XT-8 instrument platform. It requires a small blood sample for analysis and provides results quickly, facilitating timely clinical decision-making. Clinicians should ensure proper sample collection and handling to maintain accuracy.
Related Literature
The linked study evaluated the platform's ability to rapidly genotype CYP2C9 and VKORC1 alleles, which are crucial for determining warfarin sensitivity. The study confirmed the device's accuracy in identifying these genetic variants, supporting its clinical utility in personalized medicine. However, the study was limited by its sample size and did not assess long-term clinical outcomes.
Frequently Asked Questions
What is the eSensor Warfarin Sensitivity used for?
It is used to genotype patients for genetic markers that affect warfarin metabolism, helping to personalize dosing.
What specialties typically use this device?
Cardiology, hematology, and pharmacogenomics specialists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for genotyping patients to determine warfarin sensitivity, aiding in personalized dosing strategies.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.