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esensor warfarin sensitivity saliva test
Genmark Diagnostics
Summary: The Esensor Warfarin Sensitivity Saliva Test by Genmark Diagnostics is used to determine genetic sensitivity to warfarin. It aids clinicians in personalizing anticoagulant therapy.
FDA Clearance Information
Pathway
510K
Number
K110786 ↗
Decision Date
December 2, 2011
Product Code
NSU
Device Class
Class 2
Evidence
0 studies
The Esensor Warfarin Sensitivity Saliva Test was cleared through the FDA 510(k) pathway on December 2, 2011. It is manufactured by Genmark Diagnostics and is classified as a Class 2 device.
What It Is
The Esensor Warfarin Sensitivity Saliva Test is a genetic test that analyzes saliva samples to detect genetic markers associated with sensitivity to warfarin, a common anticoagulant. By identifying these genetic variations, the test helps clinicians tailor warfarin dosing to individual patients, minimizing the risk of adverse effects and improving therapeutic outcomes.
Clinical Applications
This test is commonly used in cardiology and hematology settings where patients are prescribed warfarin for conditions like atrial fibrillation, deep vein thrombosis, or pulmonary embolism. It is particularly useful in outpatient clinics and hospitals where personalized medicine approaches are emphasized. The test is applicable to adult patients who are newly prescribed warfarin or those experiencing difficulties with standard dosing.
Indications for Use
The FDA-cleared indications for this test involve assessing genetic factors that influence a patient's response to warfarin. It is intended for patients who require anticoagulation therapy and may benefit from personalized dosing strategies.
Practical Considerations
The test requires a saliva sample, which is non-invasive and easy to collect. It is compatible with standard laboratory equipment used for genetic testing. Clinicians should ensure proper sample collection and handling to maintain accuracy.
Frequently Asked Questions
What is the Esensor Warfarin Sensitivity Saliva Test used for?
It is used to determine genetic sensitivity to warfarin, aiding in personalized anticoagulant dosing.
What specialties typically use this device?
Cardiology and hematology specialties commonly use this test, particularly in settings focused on personalized medicine.
What are the FDA-cleared indications?
The test is indicated for assessing genetic factors influencing warfarin response, aiding in personalized dosing strategies for anticoagulation therapy.
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.