FDA Device Clearances: Warfarin Assay, Human T-Lymphotropic Virus Test, Radiation Therapy Device
The US Food and Drug Administration (FDA) has granted 510(k) clearance for an assay to determine individual response to warfarin treatment, approved a Biologics License Application for a test to screen for human T-lymphotropic virus (types 1 and 2), and granted 510(k) clearance for a device for the administration of radiation therapy.
Assay (Infiniti 2C9-VKORC1 Multiplex Assay) for Detection of Warfarin Sensitivity
On January 23, the FDA granted 510(k) clearance for its assay (Infiniti 2C9-VKORC1 Multiplex Assay, AutoGenomics, Inc) to determine the individual response to treatment with warfarin, a widely prescribed oral anticoagulant medication.
Warfarin prevents blood from clotting through the inhibition of vitamin K–dependent coagulation factors and is used in a variety of pulmonary disorders. Though the drug is effective, therapeutic dose can vary widely between patients and has thus been associated with major bleeding complications.
The assay is designed to determine genetic variants of CYP2C9, an enzyme that has a role in the metabolism of warfarin that can influence dosing.
Test (Abbott Prism) to Screen for Human T-Lymphotropic Virus
On January 18, the FDA approved a Biologics License Application for a test (Abbott Prism HTLV-I/HTLV-II, Abbott Diagnostics) to use in the screening of individual blood and plasma samples for antibodies to the human T-lymphotropic virus (HTLV), types 1 and 2.
According to the Centers for Disease Control and Prevention, Atlanta, Georgia, HTLV-1 and HTLV-2 are closely related human retroviruses that are associated with T-cell leukemia/lymphoma and neurodegenerative disease. Screening of the US blood supply for HTLV-1/2 began in November 1988 to protect patients from the transmission of the viruses through blood components.
The new device consolidates testing into a single system and is capable of running 160 samples per hour. It has not been validated for use with pooled specimens and is not intended for the screening of specimens from cord blood or for laboratory diagnosis of HTLV-1/2 infection.
Device (Artists Solution) for Radiation Therapy
On January 23, Siemens Medical Solutions announced that the FDA granted 510(k) clearance for its device (Artists Solution) for the administration of radiation therapy in the treatment of cancer.
The device is designed to deliver adaptive radiation therapy, allowing for maximum dosage to be delivered to target tissues as the tumor size and shape change during the course of treatment, through the use of multiple imaging modalities.
