On July 22, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a dermatologic diagnostics company providing personalized genomic information to inform treatment decisions, reported data presentations on two of its skin cancer gene expression profile tests at the Society of Dermatology Physician Assistants (SDPA) Annual Summer Dermatology Conference 2021, taking place from July 22-25, 2021 (Press release, Castle Biosciences, JUL 22, 2021, View Source [SID1234585109]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

DecisionDx-Melanoma:

DecisionDx-Melanoma is Castle’s gene expression profile test that uses an individual patient’s tumor biology to predict risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node (SLN) positivity, independent of traditional staging factors. Castle presented new data assessing the clinical utility of the DecisionDx-Melanoma test through a poster entitled "Clinical Utility of the 31-Gene Expression Profile Test on the Management of Cutaneous Melanoma by Nurse Practitioners and Physician Assistants." The study highlights nurse practitioners’ and physician assistants’ (NP/PAs) attitudes toward the clinical use of DecisionDx-Melanoma in patients diagnosed with cutaneous melanoma. The poster can be accessed here.

Study methods and findings:

In 2020, an institutional review board (IRB)-approved, 20-question study was conducted to understand the perception and clinical use of DecisionDx-Melanoma by clinicians, including NP/PAs.
Of the 711 survey respondents, 266 self-identified as NP/PAs, with 50% of those (n=133) reporting ordering DecisionDx-Melanoma within the previous year.
89% of the NP/PAs responded that comprehensive prognostic testing (including DecisionDx-Melanoma) could improve patient care.
Most NP/PAs who use DecisionDx-Melanoma (97%) would recommend additional prognostic testing to close friends or family members compared to just 58% of those who do not use DecisionDx-Melanoma.
Among the NP/PAs who ordered DecisionDx-Melanoma in the previous year:
99% would recommend the test to a colleague.
Most would consider patient management changes for patients with a T1 tumor (82%) or stage I melanoma (81%) who received a high-risk Class 2B DecisionDx-Melanoma test result.
"We are pleased that the study results reinforce the clinical utility of DecisionDx-Melanoma in patients diagnosed with cutaneous melanoma," said Bob Cook, Ph.D., senior vice president of research and development. "The study data demonstrate that the majority of NP and PA respondents would consider altering patient management for a thin (T1) tumor or Stage 1 melanoma that received a high-risk DecisionDx-Melanoma result."

DecisionDx-SCC:

DecisionDx-SCC is Castle’s prognostic gene expression profile test for patients diagnosed with high-risk cutaneous squamous cell carcinoma (SCC), designed to use a patient’s tumor biology to predict individual risk of metastasis for patients with SCC and one or more risk factors. Castle presented data on DecisionDx-SCC through a poster entitled "Real-world clinical usage data demonstrates appropriate utilization of the prognostic 40-gene expression profile test for cutaneous squamous cell carcinoma with one or more risk factors." The poster can be found here.

Study methods and findings:

The objective of the study was to demonstrate the independent prognostic value of DecisionDx-SCC within existing risk assessment methods and report on the early clinical usage of DecisionDx-SCC.
Summary metrics were generated on the first 1000 samples received for DecisionDx-SCC testing that met clinical testing criteria. Metrics on early clinical usage include:
Technical reliability of DecisionDx-SCC was 96.3%.
69.0% of samples received DecisionDx-SCC Class 1 results, 26.0% received DecisionDx-SCC Class 2A results and 1.3% received DecisionDx-SCC Class 2B results.
52% of tested patients had three or more risk factors.
This study demonstrated that the intended use population (high-risk SCC patients with one or more risk factors) aligns with the cases that were submitted for clinical testing.
The study also found that DecisionDx-SCC results can be applied as an adjunct to enhance SCC risk stratification and contribute to risk-appropriate surveillance and treatment decisions.
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 5,700 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. To predict likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithm, i31-GEP, to produce an integrated test result. i31-GEP is an artificial intelligence-based neural network algorithm (independently validated in a cohort of 1,674 prospective, consecutively tested patients with T1-T4 cutaneous melanoma) that integrates the DecisionDx-Melanoma test result with the patient’s traditional clinicopathologic features. 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. Through March 31, 2021, DecisionDx-Melanoma has been ordered more than 73,396 times for use in patients with cutaneous melanoma.

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

About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1 (low), 2A (moderate) or 2B (high) risk category, predicts individual metastatic risk to inform risk-appropriate management.

Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management.