DecisionDx-UM (Uveal Melanoma Gene Expression)

Label Mnemonic:	CASTLE
Epic code:	LAB8286
Downtime form:	Doctor/Provider Orders - Pathology Core and Specialty Care Nursery

Commercial Mailout Laboratory
6240-8 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