Castle Biosciences Announces Publication of Clinical Utility, Long-Term Outcomes Data and Meta-Analysis for DecisionDx-UM for Patients with Uveal Melanoma
Study Published Recently in Ocular Oncology and Pathology
The article titled, “Gene expression profiling in uveal melanoma: five-year prospective outcomes and meta-analysis,” was published in the peer-reviewed journal Ocular Oncology and Pathology.
DecisionDx-UM is Castle’s 15-gene expression profiling (GEP) test developed to identify patients at low risk (Class 1) or high risk (Class 2) of metastasis, based on the unique biology of their primary tumor, and is the current standard of care for UM patients. It is estimated that nearly 8 in 10 patients diagnosed with UM in the
The multicenter CLEAR Registry Study (Clinical Application of DecisionDx-UM Gene Expression Assay Results) was designed to prospectively evaluate management plans and five-year clinical outcomes for UM patients tested with DecisionDx-UM as part of their clinical care. The median follow-up time for patients who did not develop metastasis was 4.9 years, reflecting the longest follow-up reported to date for any prognostic tool for UM.
“The accurate and reliable identification of a patient’s metastatic risk is critical for clinical planning and decision-making,” commented first author,
Study Background and Highlights:
- Eighty-nine patients with DecisionDx-UM results were prospectively enrolled at four centers. Sample size calculations indicated that 29 patients would be sufficient to demonstrate a statistically significant difference in metastatic rates between Class 1 and Class 2 patients, while 47 patients would be sufficient to detect differences in melanoma-specific mortality.
- Physician-recommended management plans were collected, and clinical outcomes tracked every six months.
- Five-year DecisionDx-UM Class 1 and DecisionDx-UM Class 2 metastasis-free survival rates were 90% and 41% (p<0.0001), respectively, and melanoma-specific survival rates were 94% and 63% (p=0.0007), respectively.
- In multivariate analysis with clinicopathologic features, including age, ciliary body involvement, largest basal diameter and tumor thickness, the DecisionDx-UM Class 2 result was the only statistically significant predictor of metastasis, with a hazard ratio (HR) of 7.53 (p<0.0001).
- A meta-analysis with published cohorts found that patients with a Class 2 result had a HR of 8.70 (p<0.0001) for metastasis and 7.21 (p<0.0001) for mortality.
- All patients with DecisionDx-UM Class 2 (high-risk) test results were managed with high-intensity surveillance (imaging and/or liver function tests every 3-6 months), while 80% of Class 1 (low-risk) patients were managed with low-intensity surveillance (annual imaging and/or liver function tests, p<0.0001).
- The results of this study support that DecisionDx-UM is used to appropriately guide metastatic surveillance in UM patients. High-risk Class 2 patients were managed more intensely, in accordance with an observed metastatic rate of greater than 50%, while low-risk Class 1 patients were managed with low-intensity surveillance, resulting in appropriate utilization of healthcare resources.
DecisionDx-UM is a 15-gene expression profile (GEP) test that uses an individual patient’s tumor biology to predict individual risk of metastasis. DecisionDx-UM is the standard of care in the management of uveal melanoma in the majority of ocular oncology practices in
It is estimated that nearly 8 in 10 patients diagnosed with uveal melanoma in the
DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are trademarks of
The information in this press release contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning the ability of DecisionDx-UM test results to optimize diagnostic treatment decisions. The words “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “will,” “would” and similar expressions are intended to identify forward-looking statements; although, not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation, the risks set forth in our Annual Report on Form 10-K for the year ended
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