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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 ?
510(k)
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.
FDA-Cleared Indications
- Detection of specific genetic variants associated with warfarin metabolism and response.
- Use with clinical information to assist clinicians in managing warfarin therapy.
- Intended for testing human blood specimens according to the cleared test labeling.
Clinical Applications
- Supporting initial warfarin-dose selection when pharmacogenetic information is being considered.
- Helping interpret genetic factors in patients who have an unusual or unstable response to warfarin.
- Providing genetic information alongside INR results, clinical factors, and other medication information during anticoagulation management.
Practical Considerations
- This is a laboratory genetic test, not an implanted or therapeutic device.
- The result should not be used alone to select or change a warfarin dose; INR monitoring, age, diet, interacting medicines, liver function, and bleeding risk also matter.
- The test requires an appropriately collected human blood specimen and laboratory processing according to the manufacturer’s instructions.
- The test does not replace routine INR monitoring or clinical follow-up during warfarin treatment.
- Because the device is not implanted and does not expose the patient to magnetic fields, MRI safety labeling is generally not applicable.
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.