Newly Published Independent Study on a Prospective Cohort Highlights DecisionDx-Melanoma Prognostic Test’s Ability to Accurately Identify High-Risk Melanoma Patients
Published: Aug 09, 2018
Results from this second prospective study are consistent with prior four clinical validation studies
FRIENDSWOOD, Texas--(BUSINESS WIRE)-- Castle Biosciences, Inc., the skin cancer diagnostics company providing molecular diagnostics to improve cancer management decisions, today announced the publication of an independent study from a dermatology practice, in a prospectively collected cohort, showing that the DecisionDx®-Melanoma prognostic test can accurately identify patients at high and low risk of metastasis and death from melanoma. Patients identified as high risk were found to be 22 times more likely to develop metastasis than those with a low-risk test result. Overall this 256-patient study is consistent with previous prospective and retrospective studies and confirms the prognostic value of the DecisionDx-Melanoma test. The study was authored by Dr. Bradley Greenhaw and colleagues and published in Dermatologic Surgery.
- High negative predictive value of 98.6% provides a high degree of confidence in a low risk of metastasis for Class 1 patients.
- Class 2 patients were 22 times more likely to develop metastasis than patients with a Class 1 result.
- The 5-year melanoma-specific survival (MSS) rate was also significantly different between groups with 99% survival for Class 1 patients and 79% survival for Class 2 patients (p<0.0001).
- The authors indicate that they now offer the DecisionDx-Melanoma test to all patients with invasive cutaneous melanoma and provide more intensive follow-up for Class 2 patients to support timely detection of metastasis and earlier intervention with therapy.
“These robust findings from an independent study demonstrating that the DecisionDx-Melanoma test can identify early-stage melanoma patients who are at high risk for metastasis and death are consistent with previous retrospective and prospective studies,” said lead author Bradley Greenhaw, M.D., Dermatology Center of North Mississippi, Tupelo, Mississippi. “In this dermatology practice, as in many others across the country, the DecisionDx-Melanoma test has been incorporated into practice protocols to improve patient management decisions based on recurrence risk beyond clinicopathologic staging alone.”
- The study was conducted at a single dermatology center and included 256 patients who were identified using the center’s prospectively collected melanoma registry. Patients were diagnosed with cutaneous melanoma during the previous 5 years and were prospectively tested with DecisionDx-Melanoma as part of their initial diagnostic work-up or tested as part of their follow-up care. Retrospective chart review was used in cases of missing data in the registry.
- 86% of patients had American Joint Committee on Cancer (AJCC) Stage I melanoma, and 14% had Stage II disease.
- 214 patients had a Class 1 DecisionDx-Melanoma test result; 42 patients were Class 2. Mean follow-up time was 23 months.
The paper can be accessed at the Dermatologic Surgery website.
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 1,300 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 1,400 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in multi-center and single-center studies. 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, DecisionDx®-CMSeq; 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, Texas (Houston), and has laboratory operations in Phoenix, Arizona. More information can be found at www.CastleBiosciences.com.
DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are the trademarks of Castle Biosciences, Inc. Any other trademarks are the property of their respective owners.
Castle Biosciences, Inc.
Derek Maetzold, 866-788-9007
President and CEO
Source: Castle Biosciences, Inc.