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verigene system verigene warfarin metabolism nucleic acid test
Nanosphere
Summary: The Verigene Warfarin Metabolism Nucleic Acid Test by Nanosphere is used to assess genetic factors affecting warfarin metabolism. It is primarily used by clinicians managing anticoagulation therapy.
FDA Clearance Information
Pathway
510K
Number
K070804 ↗
Decision Date
September 17, 2007
Product Code
ODW
Device Class
Class 2
Evidence
0 studies
The Verigene Warfarin Metabolism Test was cleared by the FDA via the 510(k) pathway on September 17, 2007. Manufactured by Nanosphere, it is a Class 2 device.
What It Is
The Verigene Warfarin Metabolism Nucleic Acid Test is a diagnostic tool that analyzes genetic variations affecting the metabolism of warfarin, a common anticoagulant. It uses nucleic acid technology to detect specific genetic markers that influence how patients metabolize warfarin. This information helps clinicians tailor warfarin dosing to individual patients, reducing the risk of adverse effects.
Clinical Applications
This test is commonly used in settings where anticoagulation therapy is managed, such as cardiology, hematology, and primary care. It is particularly useful for patients starting warfarin therapy or those with unstable INR levels. By identifying genetic variations, clinicians can optimize dosing strategies and improve patient outcomes.
Indications for Use
The test is indicated for patients who are prescribed warfarin and need personalized dosing based on their genetic makeup. It helps identify individuals who may require higher or lower doses due to their unique genetic profile.
Practical Considerations
The Verigene system is compatible with standard laboratory equipment and requires a small blood sample for analysis. Results are typically available within a few hours, allowing for timely adjustments to warfarin dosing. Clinicians should ensure proper sample handling to maintain test accuracy.
Frequently Asked Questions
What is the Verigene Warfarin Metabolism Test used for?
It is used to determine genetic factors that affect how a patient metabolizes warfarin, aiding in personalized dosing.
What specialties typically use this device?
Cardiology, hematology, and primary care specialists commonly use this test to manage anticoagulation therapy.
What are the FDA-cleared indications?
The test is indicated for assessing genetic variations in patients prescribed warfarin to optimize dosing and improve safety.
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.