On February 3, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a leader in transforming disease management and improving patient outcomes through innovative diagnostics, reported a collaboration with the National Cancer Institute (NCI) to link DecisionDx-Melanoma testing data with data from the Surveillance, Epidemiology and End Results (SEER) Program’s registries on cutaneous melanoma (CM) cases (Press release, Castle Biosciences, FEB 3, 2022, View Source [SID1234607713]).

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CM cases in the SEER registries that were diagnosed between 2013-2018 were linked with DecisionDx-Melanoma results and additional clinicopathologic information from patients tested between 2013-2018. The Company expects to continue collaborating with the NCI to link the SEER registries’ CM cases diagnosed post-2018 with DecisionDx-Melanoma test results. The initial linked dataset is expected to be broadly available to interested researchers through the standard data request process for SEER Specialized Datasets in 2022.

Data analysis from the first subset of patients was shared in a poster presentation at the 2022 Winter Clinical Dermatology Conference, held Jan. 14-19 in Koloa, Hawaii.

"We are excited to collaborate with the NCI to link DecisionDx-Melanoma test results with the SEER registries’ data," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "Castle is committed to providing clinically actionable tests to improve patient outcomes. Analysis from the first subset of patients (65 years or older at time of diagnosis and diagnosed in 2016 or later) provides real-world evidence of the capability of our test to do just that. Specifically, when controlling for demographic and clinicopathological variables, patients tested with DecisionDx-Melanoma had better overall survival rates over 2.5 years than patients not tested."

The poster, titled "31-gene expression profile testing survival benefit in a population-based analysis of cutaneous melanoma patients ≥65 years of age," highlighted the first analysis of Castle’s DecisionDx-Melanoma testing data in the NCI’s SEER Program registry. The poster can be viewed here.

Study methods and findings:

DecisionDx-Melanoma is Castle’s gene expression profile test that uses an individual patient’s tumor biology to predict the risk of cutaneous melanoma metastasis or recurrence, as well as the risk of sentinel lymph node (SLN) positivity, independent of traditional staging factors. Among other outputs of the test, DecisionDx-Melanoma classifies a patient’s tumor as lowest risk of recurrence/metastasis (Class 1A), increased risk of recurrence/metastasis (Class 1B/2A) or highest risk of recurrence/metastasis (Class 2B).
All incident CM cases diagnosed between 2013-2018 in the NCI’s SEER Program registry were included in the study. The SEER registries linked CM cases in the registry to DecisionDx-Melanoma testing data provided by Castle Biosciences.
While all CM diagnoses between 2013-2018 were included in the linkage, this analysis was limited to a subset of 2,048 patients with Stage I-III melanoma who were ≥65 years or older at the time of diagnosis and were diagnosed between 2016-2018 to account for access to adjuvant therapy.
Patients tested with DecisionDx-Melanoma were successfully matched to those not tested with DecisionDx-Melanoma based on clinical, pathological and demographic data.
After matching, patients tested with DecisionDx-Melanoma had better overall survival rates than patients who had not been tested, demonstrating a direct effect of DecisionDx-Melanoma testing on patient survival (hazard ratio=0.66 compared to untested patients, p=0.002).
The results also confirmed DecisionDx-Melanoma’s ability to stratify patient risk in an unselected, prospectively tested population of CM patients into low (Class 1A) and high-risk (Class 2B) mortality groups.
Patients who received a DecisionDx-Melanoma high-risk result had a ten-fold increase in death rate compared to patients who received a low-risk result (12.3% death rate for a Class 2B result compared to 1.5% for a Class 1A result), demonstrating the independent prognostic value of the test.
In sum, the study data provide direct evidence that CM patients tested with DecisionDx-Melanoma have better survival rates than untested patients, suggesting that the test can aid in risk-aligned treatment plans for improved patient outcomes and survival rates.
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 risk of sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 6,000 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 six prospective risk of recurrence studies including more than 1,600 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. To predict risk of recurrence and likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithms, i31-ROR and i31-SLNB, to produce an Integrated Test Result. Through Sept. 30, 2021, DecisionDx-Melanoma has been ordered 84,195 times for use in patients with cutaneous melanoma.

More information about the test and disease can be found at www.CastleTestInfo.com.

About the SEER Program

The Surveillance, Epidemiology and End Results (SEER) Program (View Source) is an authoritative source for cancer statistics in the United States. The SEER Program provides information on cancer statistics in an effort to reduce the cancer burden among the U.S. population and is supported by the Surveillance Research Program (SRP) in the NCI’s Division of Cancer Control and Population Sciences (DCCPS). The SEER Program registries collect data on cancer cases diagnosed in their catchment area from various locations and sources throughout the United States. Data collection began in 1973 with a limited number of registries and continues to expand to include even more areas and demographics today covering 48% of US population. The SEER Program registries link to data provided by a variety of federal and commercial partners to support the research community in conducting cancer surveillance and epidemiological research. The data are available to qualified researchers.