DecisionDx is a molecular diagnostic test developed at and licensed from The University of Texas M. D. Anderson Cancer Center. The test is used to prospectively predict patient outcome to treatment for various cancers. DecisionDx-UM is a more specific prognostic test that determines the metastatic risk associated with ocular melanoma tumors of the eye. The test classifies tumors as Class 1A (low metastatic risk), Class 1B (long-term metastatic risk), or Class 2 (immediate, high metastatic risk). The test is not FDA approved but it should be noted that Clinical Laboratory Improvement Amendments(CLIA) does not approve tests but rather certifies laboratories. (Many other tests commonly used in oncology do not have FDA clearance).
In general, a variety of similar tests has recently been licensed and marketed in various tumor types and at this time, none of them are generally accepted or recommended by guidelines.
Of all Decision Dx, the uveal melanoma test has the most support. It has been validated in retrospective analysis, especially in showing that prognoses varied between different stages of melanoma and shown to be independent of and more accurate than current histologic factors used to predict an individual patient’s metastatic risk, including AJCC stage, Breslow’s thickness and mitotic rate. It had not been prospectively tested. The DecisionDx for uveal melanoma, however, has support for AJCC(American Joint committee on Cancer, version 7, 2010).
Harbour, J.W. (2011). Molecular Research in Uveal Melanoma: Ushering in a New Standard of Care. Retina Times, 29, 36-7
Aaberg, (2012). Practical Approaches to Needle Biopsy and Genetic Diagnosis for Ocular Melanoma. Retina 2012: The Winds of Change. Lecture conducted from The American Academy of Ophthalmology, Chicago, IL.
Chappell, et al. (2012). Uveal Melanoma: Molecular Pattern, Clinical Features, and Radiation Response. American Journal of Ophthalmology, 227-232.
Petrausch U,Martus P,Tönnies H,et al.Significance of gene expression analysis in uveal melanoma in comparison to standard risk factors for risk assessment of subsequent metastases.Eye.2008;22:997-1007.
Damato B, Coupland SE.Translating uveal melanoma cytogenetics into clinical care. Arch Ophthalmol. 2009;127:423-429.
Balch CM, Gershenwald JE, Soong SJ, et al. Multivariate analysis of prognostic factors among 2,313 patients with stage III melanoma: comparison of nodal micrometastases versus macrometastases. J Clin Oncol 2010;28:2452-9.
Bichakjian CK, Halpern AC, Johnson TM, et al. Guidelines of care for the management of primary cutaneous melanoma. J Am Acad Dermatol 2011; 65(5): 1032-1047.
Plasseraud KM, Cook RW, Tsai T, et al. Clinical Performance and Management Outcomes with the DecisionDx-UM Gene Expression Profile Test in a Prospective Multicenter Study. J Oncol. 2016;2016:5325762.
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For DecisonDx for glioblastoma see here