US-based molecular diagnostics company Castle Biosciences has reported positive CLEAR study data of its gene expression profile (GEP) test, DecisionDx-UM, to indentify metastasis in patients with uveal melanoma (UM).
The DecisionDx-UM test examines GEP, or the molecular signature, of an individual’s tumour and identifies the risk of an occurrence of metastasis.
It can predict the statistical rates of survival over a period of five years.
The prospective, multicentre Clinical Application of DecisionDx-UM Gene Expression Assay Results (CLEAR) study was designed to record the clinical management and metastatic results of 70 patients suffering from UM with low-risk Class 1 or high-risk Class 2 GEP test results.
None of the patients were diagnosed to indicate the occurrence of metastasis at the time of primary tumour treatment.
The CLEAR study demonstrated that the GEP test accurately predicts metastatic risk for UM patients and is being used by physicians to appropriately guide patient care decisions and potentially improve net health outcomes.
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The results suggested that GEP test predicts the metastatic risk for UM patients with accuracy and hence can aid the physicians to take patient care decisions thereby resulting to improved health outcomes.
Retina Specialists of Michigan ocular oncologist Michigan State University Medical School assistant clinical professor and study co-author Thomas Aaberg said: “The ability to accurately gauge metastatic risk in uveal melanoma, a cancer for which clinicopathologic staging is inadequate, is an important advance and critical to disease management.
“Results from the CLEAR study support the wide adoption of DecisionDx-UM, and demonstrate the impact the test has made thus far on follow-up care plans for patients.
“The GEP test is also being used to identify and appropriately enroll patients in clinical trials designed to adjuvantly treat high-risk Class 2 UM patients.”
The DecisionDx-UM test has been validated by multiple studies namely an independent, prospective study conducted by the Collaborative Ocular Oncology Group (COOG) where the test was able to classify tumours while exhibiting accuracy and reliability.