On October 7, 2019 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported the publication of an expert panel consensus statement that includes appropriate use criteria for DecisionDx-Melanoma in patients with cutaneous melanoma (Press release, Castle Biosciences, OCT 7, 2019, View Source [SID1234540092]). The study was published in the peer-reviewed journal SKIN: The Journal of Cutaneous Medicine.
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A panel of nine expert dermatologists, dermatologic surgeons, and dermatopathologists performed a systematic review of published evidence and developed appropriate use criteria supporting the integration of DecisionDx-Melanoma and two other validated, widely used molecular tests in melanoma patient care. The systematic review of peer-reviewed medical literature identified studies relating to clinical validity, outcomes or utility of DecisionDx-Melanoma. Employing a modified Delphi consensus technique, the panel determined the level of evidence for publications as well as an overall strength of recommendation for selected indications using standard Strength of Recommendation Taxonomy (SORT) methodology.
Key Findings
Eleven publications were identified as achieving quality levels 1 or 2, with two publications achieving the highest level of evidence (Level 1).
Eight consensus-based appropriate use criteria recommendations achieved a rating of "A" or "B", with "A" rating indicating the highest strength of recommendation.
The expert consensus-based appropriate use criteria provide an evidence-based framework to integrate the DecisionDx-Melanoma test into the management of patients with cutaneous melanoma.
"This important publication is the first to provide expert consensus-based appropriate use criteria to help clinicians integrate technologies like the DecisionDx-Melanoma test into their melanoma practice," said study co-author Darrell S. Rigel, M.D., M.S., Clinical Professor at New York University (NYU) School of Medicine. "The DecisionDx-Melanoma test has been well validated as a predictor of risk of metastasis or recurrence. The appropriate use criteria recommendations align with the current clinical use of DecisionDx-Melanoma to guide the post-diagnostic decisions to perform a sentinel lymph node biopsy surgical procedure in certain patients, and determine appropriate management plans regarding follow-up regimens, inclusion of imaging and referral to oncology."
The full published study can be accessed at the journal’s website.