Castle Biosciences Announces Publication of a Systematic Review and Meta-Analysis Demonstrating DecisionDx-Melanoma Test as Independent, Significant Predictor of Recurrence and Metastatic Risk

The article titled, “Molecular risk prediction in cutaneous melanoma: a meta-analysis of the 31-gene expression profile prognostic test in 1,479 patients,” appeared in the Journal of the American Academy of Dermatology (JAAD).

“This systematic review and meta-analysis are important because they further demonstrate the strength and consistency of the DecisionDx-Melanoma test as a significant, independent predictor of recurrence and metastasis in patients with Stage I-III melanoma, across these unique study cohorts,” said lead author Bradley Greenhaw, M.D., Dermatology Center of North Mississippi, Tupelo, Mississippi. “The meta-analysis shows the value of using the DecisionDx-Melanoma gene expression profile test in combination with American Joint Committee on Cancer (AJCC) staging to optimize melanoma prognostication.”

Systematic Review and Meta-Analysis Background:

This study was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)¹.

Multiple published archival and prospective studies have described the prognostic capability, performance and clinical utility of the DecisionDx-Melanoma test to assess recurrence risk and inform patient management decisions on sentinel lymph node recommendations, follow up, surveillance imaging and referrals for patients with cutaneous melanoma.

This systematic review and meta-analysis were performed to evaluate the cumulative prognostic effect of the test across multiple cohorts with a focus on differences in recurrence and distant metastasis between patients with a DecisionDx-Melanoma Class 1A (lowest risk) and Class 2B (highest risk) test result. Four study cohorts, which included a total of 1,479 non-overlapping patients with Stage I-III melanoma, were included in the analysis.

Systematic Review and Meta-Analysis Results:

• The DecisionDx-Melanoma test was found to be a consistent, independent and significant predictor of recurrence and metastatic risk in the meta-analysis across four study cohorts, achieving the highest Strength of Recommendation Taxonomy (SORT) level for a prognostic biomarker (Level 1 evidence).
• The DecisionDx-Melanoma risk assessment is independent from other clinical factors (age, Breslow tumor thickness, ulceration and node status) and improves upon risk assessment performed with staging factors alone.
• For melanoma recurrence, multivariate analysis showed that patients with DecisionDx-Melanoma Class 2B tumors are 2.90 times more likely (Hazard Ratio) to experience a recurrence than patients with Class 1A tumors (p<0.0001).
• For distant metastasis, patients with Class 2B tumors are 2.75 times more likely to experience a distant metastasis than patients with Class 1A tumors (p<0.0001).
• Despite differences in populations and study design, heterogeneity among the four studies was not significant.

The SORT system is used by the American Academy of Dermatology (AAD) and other organizations to evaluate the quality, quantity and consistency of evidence supporting tests such as DecisionDx-Melanoma. The SORT scale evaluates both the quality of the evidence (Level 1, 2 or 3) and strength of the recommendation (A, B or C).

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1600 patients. Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter studies that included more than 3,000 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Since its commercial launch in 2015, through December 31, 2019, DecisionDx-Melanoma has been ordered 51,967 times for use in patients with cutaneous melanoma.

More information about the test and disease can be found at www.SkinMelanoma.com.

About Castle Biosciences

Castle Biosciences (Nasdaq: CSTL) is a commercial-stage dermatologic cancer company focused on providing physicians and their patients with personalized, clinically actionable genomic information to make more accurate treatment decisions. The Company currently offers tests for patients with cutaneous melanoma (DecisionDx^®-Melanoma, DecisionDx^®-CMSeq; www.SkinMelanoma.com) and uveal melanoma (DecisionDx^®-UM, DecisionDx^®-PRAME and DecisionDx^®-UMSeq; www.MyUvealMelanoma.com), with products in development for other underserved cancers, the two most advanced of which are focused on patients with cutaneous squamous cell carcinoma, and patients who have a difficult-to-diagnose pigmented lesion. Castle Biosciences is based in Friendswood, Texas (Houston), and has laboratory operations in Phoenix, Arizona. For more information, visit www.CastleBiosciences.com.

DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are trademarks of Castle Biosciences, Inc.

Forward-Looking Statements

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-Melanoma 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 December 31, 2019, and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law.

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¹ From the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement: Under PRISMA, a systematic review evaluates a clearly formulated question using systematic and explicit methods to identify, select, and critically appraise relevant research, and to collect and analyze data from the studies that are included in the review. Statistical methods (meta-analysis) may or may not be used to analyze and summarize the results of the included studies. Meta-analysis refers to the use of statistical techniques in a systematic review to integrate the results of included studies.

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