FLT3 ITD and TKD Mutation Assay
Fees Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
This test was developed and its performance characteristics determined by the Laboratory for Personalized Molecular Medicine. It has not been cleared or approved by the U.S. Food and Drug Administration. However, such approval is not required for clinical implementation, and test results have been shown to be clinically useful. The Laboratory of Personalized Molecular Medicine is CLIA certified and CAP accredited to perform high complexity testing.
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
81245 â€“ FLT3 ITD mutation detection
81479 â€“ Unlisted molecular pathology procedure
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|
|Z3562||FLT3 Internal Tandem Dup (ITD)||In Process|
|Z3277||FLT3 TKD Mutation||In Process|