News Details

FRIENDSWOOD, Texas--(BUSINESS WIRE)-- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced new data from UTILISE (Clinical Utility and Health Outcomes Study), a prospective, multi-center, clinical utility study of DecisionDx®-SCC, designed to capture the real-world impact of DecisionDx-SCC test results on the management of patients with cutaneous squamous cell carcinoma (cSCC) and one or more risk factors. This first analysis showed that DecisionDx-SCC test results positively impacted patient management in over 80% of the patients enrolled in the study, consistent with previous clinical utility studies demonstrating that the test’s results can impact risk-appropriate changes in patient management plans, within established guidelines.

“A true litmus test of any prognostic test is its ability to provide clinically actionable information that can drive positive change in the overall management of patients and more informed decisions than may be possible without the test’s results,” said Matthew S. Goldberg, M.D., board-certified dermatologist and dermatopathologist and medical director at Castle Biosciences. “The initial data from our UTILISE study highlights the potential of DecisionDx-SCC test results to prompt risk-aligned changes in treatment plans for patients with high-risk cSCC, with clinical actionability rates comparable to the impact of molecular tests currently covered by Medicare for other disease states, such as breast, prostate and lung cancer.”

This data from the UTILISE study was presented during the 2022 Fall Clinical Dermatology Conference through a poster titled, “A prospective clinical utility study demonstrates that physicians use the 40-gene expression profile (40-GEP) to guide clinical management decisions for Medicare-eligible patients with cutaneous squamous cell carcinoma (cSCC).” The poster can be viewed here.

In the study, clinician recommendations for patient management are recorded before and after DecisionDx-SCC testing using standard pre-test/post-test methodology, and any additional changes in management plans and patient outcomes are recorded every six months for three years. In this analysis of Medicare-eligible patients with high-risk cSCC (n=59), clinicians indicated that the DecisionDx-SCC test result was the most influential factor impacting their management plans for 42% of the patients. Additionally, DecisionDx-SCC test results positively impacted patient management in over 80% of patients in the cohort, with clinicians reporting increased confidence in the recommended treatment plan (59%) and risk-aligned management changes based on the tests’ results (24%). While additional analyses from UTILISE are forthcoming, the initial data from this real-world study support findings in previous clinical utility studies that DecisionDx-SCC provides valuable risk-stratification information that can guide patient management decisions and risk-appropriate treatment plan changes within established guidelines.

The following additional posters highlighting the performance of Castle’s suite of tests for skin cancer were also shared during the 2022 Fall Clinical Dermatology Conference:

DecisionDx®-Melanoma

• Poster titled, “Incorporating the 31-gene expression profile test stratifies survival outcomes and leads to improved survival compared to clinicopathologic factors alone: A Surveillance, Epidemiology, and End Results (SEER) Program collaboration,” is available to view here.

Diagnostic GEP (MyPath® Melanoma and DiffDx®-Melanoma)

• Poster titled, “A clinical impact study of dermatologists’ use of the 23- or 35-gene expression profile tests to guide surgical excision and enhance management plan confidence,” is available to view here.

DecisionDx®-SCC

• Poster titled, “How Mohs surgeons utilize prognostic testing for high-risk cutaneous squamous cell carcinoma (SCC): a clinical impact study,” is available to view here.
• Poster titled, “Performance and clinical decision-making using the prognostic 40-gene expression profile (40-GEP) test in 1,018 patients with high-risk cutaneous squamous cell carcinoma (SCC),” is available to view here.

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.

About MyPath® Melanoma and DiffDx®-Melanoma

MyPath Melanoma and DiffDx-Melanoma are Castle’s two gene expression profile tests designed to provide an accurate, objective result to aid dermatopathologists and dermatologists in characterizing difficult-to-diagnose melanocytic lesions. Of the approximately two million suspicious pigmented lesions biopsied annually in the U.S., Castle estimates that approximately 300,000 of those cannot be confidently classified as either benign or malignant through traditional histopathology methods. For these cases, the treatment plan can also be uncertain. Obtaining accurate, objective ancillary testing can mean the difference between a path of overtreatment or the risk of undertreatment. Interpreted in the context of other clinical, laboratory and histopathologic information, MyPath Melanoma and DiffDx-Melanoma are designed to reduce uncertainty and provide confidence for dermatopathologists and help dermatologists deliver more informed patient management plans.

About DecisionDx®-Melanoma

DecisionDx-Melanoma is a risk stratification gene expression profile test. It is designed to inform two clinical questions in the management of cutaneous melanoma: a patient’s individual risk of sentinel lymph node (SLN) positivity and a patient's personal risk of melanoma recurrence and/or metastasis. By integrating tumor biology with clinical and pathologic factors using a validated proprietary algorithm, DecisionDx-Melanoma is designed to provide a comprehensive and clinically actionable result to guide risk-aligned patient care. DecisionDx-Melanoma has been shown to be associated with improved patient survival and has been studied in more than 9,000 patient samples. DecisionDx-Melanoma’s clinical value is supported by more than 35 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test’s results. Through June 30, 2022, DecisionDx-Melanoma has been ordered 105,239 times for patients diagnosed with cutaneous melanoma.

More information about these diseases and Castle’s tests can be found at www.CastleTestInfo.com.

About Castle Biosciences

Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics company improving health through innovative tests that guide patient care. The Company aims to transform disease management by keeping people first: patients, clinicians, employees and investors.

Castle’s current portfolio consists of tests for skin cancers, uveal melanoma, Barrett’s esophagus and mental health conditions. Additionally, the Company has active research and development programs for tests in other diseases with high clinical need, including its test in development to predict systemic therapy response in patients with moderate-to-severe psoriasis, atopic dermatitis and related conditions. To learn more, please visit www.CastleBiosciences.com and connect with us on LinkedIn, Facebook, Twitter and Instagram.

DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, MyPath Melanoma, DiffDx-Melanoma, DecisionDx-UM, DecisionDx-PRAME, DecisionDx-UMSeq, TissueCypher and IDgenetix are trademarks of Castle Biosciences, Inc.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning: the potential of DecisionDx-SCC to prompt risk-aligned changes in treatment plans for patients with high-risk cSCC and guide patient management decisions and risk-appropriate treatment plan changes within established guidelines. The words “can,” “potential” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation: subsequent study or trial results and findings may contradict earlier study or trial results and findings or may not support the results obtained in this study, including with respect to the discussion of DecisionDx-SCC in this press release; actual application of our tests may not provide the aforementioned benefits to patients; and the risks set forth under the heading “Risk Factors” in our Quarterly Report on Form 10-Q for the three months ended June 30, 2022, and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law.

Source: Castle Biosciences, Inc.