[2] The DecisionDx-UM test has become standard of care in the majority of ocular oncology centers in the U.S. and is recommended by the American Joint Committee on Cancer (AJCC).
Accurate results are achieved using both fine needle aspirate biopsies (FNAB) or formalin fixed, paraffin embedded (FFPE) tumor tissue.
The prognostic information provided by DecisionDx-UM helps physicians and their patients make individualized decisions about the surveillance and therapeutic options that are most appropriate.
[5] Unfortunately, many of the current diagnostic techniques (including imaging and liver function tests) are not able to accurately detect micrometastases until tumor nodules have grown considerably, and likely become resistant to therapy.
[8][9] The application of microarray analysis to primary untreated uveal melanomas revealed that the tumors clustered into two discreet groups based upon their expression profiles.
In subsequent experiments, Dr. Harbour's group assembled microarray information from a larger subset of uveal melanoma tumor samples, and were able to identify candidate discriminatory genes for further analysis.
[9] The current DecisionDx-UM platform was clinically validated in the COOG study, which included 514 patients with UM treated at 12 ocular oncology centers in the United States between 1998 and 2010.
Since the initial offering of DecisionDx-UM in December 2009, more than 800 clinical orders have been received for analysis by Castle Biosciences from over 55 ocular oncology centers across the U.S. Technical success and class determination was achieved for 96.2% of the samples.
Castle Biosciences, Incorporated only accepts service orders for DecisionDx-UM from licensed physicians (most commonly ocular oncologists, ophthalmologists, or retina specialists) who care for patients diagnosed with uveal melanoma.
[15] Thus, current imaging technology lacks the sensitivity for detecting micrometastases that may be present at the time of primary diagnosis of uveal melanoma.
Genetic analysis techniques have led to the identification of chromosomal abnormalities associated with metastatic tumor progression in uveal melanoma.