Publication of Independent Prospective, Multicenter Study Reinforces Accuracy of DecisionDx-Melanoma Test Recurrence Risk Prediction
Study results are consistent with previously published prospective and retrospective studies
Friendswood, TX – March 6, 2019 – Castle Biosciences, Inc., a skin cancer diagnostics company providing personalized genomic information to improve cancer management decisions, today announced publication of an independent, prospective study of patients with Stage IB and II cutaneous melanoma showing that the DecisionDx®-Melanoma gene expression profile (GEP) test accurately identifies risk of melanoma recurrence. The study was published in the Journal of the European Academy of Dermatology and Venereology. Results are consistent with the eight previously published prospective and retrospective performance studies showing the clinical value of the DecisionDx-Melanoma test to predict patient outcomes, which can help inform management decisions.
- A total of 86 patients diagnosed with cutaneous melanoma between April 2015 and December 2016 were prospectively enrolled across five tertiary melanoma referral centers in Spain.
- Patients received the DecisionDx-Melanoma test as part of their initial work-up.
- Median age was 59.2 years, mean tumor Breslow thickness was 2.5 mm and 70% of patients did not have ulcerated tumors.
- 62 patients (72%) had American Joint Committee on Cancer (AJCC 7th edition) Stage IB/IIA melanoma (considered “low risk”), and 24 patients (28%) had Stage IIB/C melanoma. Patients who had a positive sentinel lymph node biopsy result were excluded.
- Overall median follow-up time was 26 months.
- 53 patients had a Class 1 (low risk) DecisionDx-Melanoma test result; 33 patients were Class 2 (high risk).
- All 7 patients who experienced a recurrence were Class 2; no Class 1 patients experienced a recurrence (p<0.001). Two of the patients who experienced a recurrence were classified as low risk by AJCC staging but high risk (Class 2) by their DecisionDx-Melanoma test result.
- Disease-free survival rate was significantly higher for patients with a Class 1 test result compared to those with a Class 2 result based on Kaplan-Meier survival curve analysis (p<0.001).
- When AJCC staging was combined with the DecisionDx-Melanoma test result, the significant difference in disease-free survival between Class 1 and Class 2 results was maintained (p=0.001).
- Multivariate analysis that included age and AJCC staging showed the DecisionDx-Melanoma test result to be an independent predictor of recurrence (Class 2 hazard ratio=18.82, p=0.01).
“For patients with early stage melanoma, this prospective, multicenter study shows that the DecisionDx-Melanoma test can accurately predict risk of recurrence both independently and when combined with traditional AJCC staging factors,” commented Sebastian Podlipnik, M.D., Hospital Clinic of Barcelona, University of Barcelona, Spain. “These results are consistent with previous retrospective and prospective studies, and show that the DecisionDx-Melanoma test can improve identification of high-risk patients and inform decisions on surveillance and follow-up strategies.”
The full published study results can be accessed at the journal’s website.
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 over 2,900 patients. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in three multicenter studies that have included 690 patients and have demonstrated consistent results. Performance has also been confirmed in five prospective studies including over 780 patients. The consistent high performance and accuracy demonstrated in these studies, which combined have included over 1,470 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 multicenter 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 skin cancer diagnostics company dedicated to helping patients and their physicians make more informed decisions about treatment and follow up care based on the individual molecular signature of the patient’s 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 programs in development for other underserved cancers, the most advanced of which is focused on patients with cutaneous squamous cell carcinoma. 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.
Derek Maetzold, President and CEO