ADDENDUM (BRAF):



PERFORMED ON BLOCK:
PERCENTAGE OF TUMOR CELLS IN MICRODISSECTED TISSUE: %


TEST DESCRIPTION:
DNA IS EXTRACTED FROM MICRODISSECTED TUMOR TISSUE. THE EXON 15 OF THE BRAF GENE IS AMPLIFIED BY PCR. MUTATION STATUS IS DETERMINED BY PYROSEQUENCING.


THE PERFORMANCE CHARACTERISTICS OF THIS TEST WERE VALIDATED BY UNIVERSITY OF FLORIDA-PATHOLOGY LABORATORIES. THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) HAS NOT APPROVED OR CLEARED THIS TEST. HOWEVER, FDA APPROVAL OR CLEARANCE IS CURRENTLY NOT REQUIRED FOR CLINICAL USE OF THIS TEST. THE RESULTS ARE NOT INTENDED TO BE USED AS THE SOLE MEANS FOR CLINICAL DIAGNOSIS OR PATIENT MANAGEMENT DECISIONS. UF PATHOLOGY LABORATORIES IS AUTHORIZED UNDER CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) AND BY ALL STATES TO PERFORM HIGH-COMPLEXITY TESTING.


THE ABOVE TESTING WAS PERFORMED AT UNIVERSITY OF FLORIDA PATHOLOGY LABORATORIES, 4800 SW 35TH DR., GAINESVILLE, FL 32608. PHONE: 352-265-9900.