DecisionDx-UM (Uveal Melanoma Gene Expression)
Label Mnemonic: CASTLE
Epic Lab Code: LAB8286
Downtime Form: A-1a Miscellaneous Request
Commercial Mail-out Laboratory
5231 RCP
356-8593
Specimen(s):
Fresh Frozen FNAB
Specimen Instructions:
Please refer to the DecisionDx-Um Fine Needle Aspirate Biopsy Protocol.
Delivery Instructions:
Keep on ice and deliver to laboratory immediately.
Interpretive Data:
The DecisionDx-UM assay has been evaluated in over 700 patients with uveal melanoma to date. The majority of these patients participated in a prospective, multi-center study to validate the predictive accuracy of this gene expression-based molecular assay. Outcomes are collected and the ability of the molecular signature to predict metastasis is being evaluated at regular intervals. The most recent censor date (June 9, 2011) of the prospective study included 514 patients with follow-up data available for analysis. The censor date for this addendum is June 9, 2011. The actuarial outcomes for metastasis of the predicted low-risk (Class 1A), intermediate-risk (Class 1B), and the high-risk (Class 2) molecular signatures are shown below. Molecular Signature Percent Metastasis Percent Metastasis Class Free at 3 Years Free at 5 Years ----------------------------------------------------------------------- Class 1A 98% 98% Class 1B 93% 79% Class 2 50% 28% n=514; Log-rank (Mantel-Cox) test; p<0.0001
Comments:
Please print, complete, and submit the Requisition Form from CASTLE Biosciences Incorporated with the sample and the A-1a Miscellaneous Request or Epic Req.
Methodology:
DecisionDx-UM® gene expression assay for uveal melanoma is a proprietary assay that uses RT-PCR to determine the expression of a panel of 15 genes (3 control) in the supplied tumor tissue. The DecisionDx-UM classification is calculated from the gene expression results and comparing these results to a training set of patients with known outcomes.
CPT Code:
84999