FRIENDSWOOD, Texas--(BUSINESS WIRE)--Castle Biosciences, Inc., a provider of molecular diagnostics to improve cancer treatment decisions, today announced the publication of a prospective, multicenter clinical impact study that found the DecisionDx®-Melanoma test results were used to inform risk-appropriate changes in one out of every two patients tested, while remaining within the context of established practice guidelines. The paper was recently published in the peer-reviewed journal SKIN The Journal of Cutaneous Medicine.
National management guidelines recognize that a melanoma patient’s individual risk of recurrence should drive management decisions. However, patients who have been managed as low risk after having been classified as Stage I or II by clinicopathologic staging factors alone contribute to a majority of recurrences and deaths from those patients initially diagnosed with Stage I, II or III melanoma. Thus there is a clinically important need to identify biologically aggressive melanoma tumors.
Key Study Findings:
- Results showed that the DecisionDx-Melanoma test was a significant factor in guiding patient management decisions, with 49% of patients tested experiencing a change in clinical management recommendations after receipt of the test’s results (p<0.001).
- Class 1 patients showed a 36% (66 of 181) post-test change in management plans, while 85% (56 of 66) of Class 2 patients had a change following the DecisionDx-Melanoma test.
- Overall 79% of management changes were assessed to be in a risk-appropriate direction based on test result. Ninety-one percent of decreases in care were documented for low-risk (Class 1) patients, and 72% of increases in care provided for high-risk (Class 2) patients.
- The most clinically significant change observed in the study was the increase in imaging surveillance intensity (more frequent or more sensitive modality) for 64% of patients who received a Class 2 result (p<0.001).
“The study prospectively demonstrated that physicians use the DecisionDx-Melanoma test results to guide risk-appropriate changes in clinical management that match the biological risk of the melanoma tumors,” said study co-author Larry D. Dillon, MD, Surgical Oncology and General Surgery, Colorado Springs, CO. “Importantly, these management changes are aligned with guideline recommendations to direct more frequent and intense surveillance to high-risk patients.”
This multicenter, prospective study was designed to assess the clinical impact of adding the DecisionDx-Melanoma prognostic test result to traditional staging factors. Physicians examined patients to assess clinical features of the primary melanoma. All patients also underwent the DecisionDx-Melanoma gene expression profile (GEP) test. Before test results were received, physicians’ management recommendations were collected, including frequency of clinical visits, laboratory tests, imaging, adjuvant treatment discussion, plans for referral to surgical or medical oncology and sentinel lymph node biopsy (SLNB).
After receipt of the GEP test result, physicians’ management recommendations were again collected to assess clinical impact of the test result added to traditional clinicopathologic risk factors. Changes between pre- and post-test plans were categorized as an increase, decrease or no change in care.
The study included 247 patients from 16 dermatology, medical oncology or surgical oncology centers who were clinical Stage I or II at time of enrollment. The patient cohort had a median age of 63 years, median Breslow thickness of 1.1 mm and the majority were not ulcerated. Among the 167 patients who also underwent an SLNB, 11% had a positive sentinel lymph node.
The publication may be accessed on the journal’s website at: https://jofskin.org/index.php/skin/article/view/320
The DecisionDx-Melanoma test uses tumor biology to predict individual risk of melanoma recurrence and sentinel lymph node positivity independent of traditional factors. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in three multi-center studies that have included 690 patients and have demonstrated consistent results. Performance has also been confirmed in four prospective studies including 702 patients. The consistent high performance and accuracy demonstrated in these studies, which combined have included over 1300 patients, provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter studies that included over 1400 patients. Clinical impact has been demonstrated in multi-center and single-center studies showing that test results impact clinical management decisions for one of every two patients tested. More information about the test and disease can be found at www.SkinMelanoma.com.
About Castle Biosciences
Castle Biosciences is a molecular diagnostics company dedicated to helping patients and their physicians make the best possible decisions about their treatment and follow up care based on the individual molecular signature of their tumor. The Company currently offers tests for patients with cutaneous melanoma (DecisionDx®-Melanoma; www.SkinMelanoma.com) and uveal melanoma (DecisionDx®-UM, DecisionDx®-PRAME and DecisionDx®-UMSeq; www.MyUvealMelanoma.com), with development programs in other underserved cancers. Castle Biosciences is based in Friendswood, TX (Houston), and has laboratory operations in Phoenix, AZ. More information can be found at www.CastleBiosciences.com.
DecisionDx-Melanoma, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are the trademarks of Castle Biosciences, Inc. Any other trademarks are the property of their respective owners.