On December 30, 2019 Castle Biosciences, Inc. (Nasdaq: CSTL) reported that results from a study designed to perform a systematic review of the literature and establish the level of evidence for the Company’s DecisionDx-Melanoma gene expression profile test were published in the December 2019 issue of the American Journal of Clinical Dermatology (Press release, Castle Biosciences, DEC 30, 2019, View Source [SID1234552633]). The results show that the DecisionDx-Melanoma test achieves a higher level of evidence than determined by major organizations that publish guidelines on melanoma management.

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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. In this independent study by Dubin, et al. titled, "Level of Evidence Review for a Gene Expression Profile Test for Cutaneous Melanoma," the researchers conducted a review of seven development and validation studies for the DecisionDx-Melanoma test. They then applied attributes of each study to the level of evidence criteria for the American Joint Committee on Cancer (AJCC), National Comprehensive Cancer Network (NCCN) and American Academy of Dermatology (AAD). The AJCC, NCCN and AAD are considered major authoritative organizations that many dermatologists rely upon to provide skin cancer guidelines, and each employs a unique ranking system to assign a level of evidence to the management of melanoma.

Key Findings:

The evaluation of seven development and validation studies led the authors to classify DecisionDx-Melanoma as level I/II, I–IIIB and IIA according to AJCC, NCCN and AAD criteria, respectively, which are higher than the official unrated status conferred by the AJCC and NCCN and the II/IIIC rating designated by the AAD in the latest version of their melanoma guidelines.
The authors note that the differences between the study’s findings and official published ratings may be attributed to chronological issues, as many of the studies were not yet published when the organizations conducted their reviews. There was also difficulty in applying the National Comprehensive Cancer Network criteria to this prognostic test, as their guidelines were intended for evaluation of therapeutic response markers.
Based on current published data, the authors find integration of the DecisionDx-Melanoma test to be useful for patients with invasive melanoma, particularly older patients with T1/T2 (tumor depth of 2 mm or less) melanomas:
For patients with invasive melanoma, DecisionDx-Melanoma may help guide the frequency of skin examinations and utilization of a sentinel lymph node biopsy (SLNB) surgical procedure or imaging following diagnosis of melanoma.
DecisionDx-Melanoma may benefit patients aged older than 65 years diagnosed with T1/T2 melanomas in the assessment of the risks and benefits of a SLNB surgical procedure.
Three additional prospective peer-reviewed clinical validity studies published in 2019 were not included in the Dubin study, due to publication after the systematic review was completed.

The full published study can be accessed at the journal’s website.

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 3,900 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 five prospective risk of recurrence studies including more than 780 patients. Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter study cohorts that included more than 2,000 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.