Expert Panel Provides Framework for Incorporating DecisionDx-SCC Results Into Clinical Decision Making for Cutaneous Squamous Cell Carcinoma Patients With One or More Risk Factors

Article in Journal of Drugs in Dermatology provides a framework for integrating DecisionDx-SCC into patient care

Castle Biosciences, Inc. (Nasdaq: CSTL), a dermatologic diagnostics company providing personalized genomic information to inform treatment decisions, today announced a publication describing the findings of a squamous cell carcinoma (SCC) gene expression profiling (GEP) expert panel in the Journal of Drugs in Dermatology. The publication provides a framework for integrating DecisionDx-SCC into clinical practice.

Treatment plan decisions in SCC are based upon the likelihood of an individual patient’s tumor to metastasize. Data from previous studies has demonstrated that DecisionDx-SCC, Castle’s prognostic 40-GEP test designed to use a patient’s tumor biology to predict individual risk of metastasis for patients with SCC and one or more risk factors, is a significant, independent predictor of risk, compared to existing traditional clinical and pathologic staging systems.

The article, titled “Clinical Considerations for Integrating Gene Expression Profiling into Cutaneous Squamous Cell Carcinoma Management,” describes the findings of a multidisciplinary expert panel, representing backgrounds from academic medical centers and community practices. The panel also included specialties clinicians, such as Mohs surgeons, surgical oncologists and a radiation oncologist. The panel reviewed traditional risk assessment practices, guidelines and expert recommendations on DecisionDx-SCC. The panel also focused on decision-making points, where information from DecisionDx-SCC might inform the clinical management of patients with SCC and one or more risk factors.

Study findings:

• Decision points supported by DecisionDx-SCC test results include:
  • nodal evaluation
  • adjuvant radiation therapy
  • follow-up and surveillance
• The panel determined that the additional information provided by DecisionDx-SCC could:
  • help avoid unnecessary treatment and surveillance
  • allow healthcare providers to increase treatment intensity or follow-up as needed
  • inform if and when to refer a patient for medical, surgical, or radiation oncology

“This is an exciting time in the management of high-risk squamous cell carcinoma patients,” said study author, Sherrif Ibrahim, M.D., Ph.D., Mohs surgeon and associate professor in the department of dermatology at The University of Rochester Medical Center. “Progress has been made with clinicopathologic risk factor assessment. However, potential remains for these assessments to overestimate or underestimate risk. Gene expression profile testing assists us in assessing the biologic risk of individual tumors and providing personalized care for our patients, which may lead to risk appropriate reduction of treatment or increased treatment intensity and more appropriate referrals.”

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, 2A or 2B 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.

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

About Castle Biosciences

Castle Biosciences (Nasdaq: CSTL) is a commercial-stage dermatologic diagnostics company focused on providing physicians and their patients with personalized, clinically actionable genomic information to make more accurate treatment decisions. The Company currently offers tests for patients with cutaneous melanoma (DecisionDx^®-Melanoma, DecisionDx^®-CMSeq), cutaneous squamous cell carcinoma (DecisionDx^®-SCC), suspicious pigmented lesions (DecisionDx^® DiffDx™-Melanoma) and uveal melanoma (DecisionDx^®-UM, DecisionDx^®-PRAME and DecisionDx^®-UMSeq). For more information about Castle’s gene expression profile tests, visit www.CastleTestInfo.com. Castle also has active research and development programs for tests in other dermatologic 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. Castle Biosciences is based in Friendswood, Texas (Houston), and has laboratory operations in Phoenix, Arizona. For more information, visit www.CastleBiosciences.com.

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

Forward-Looking Statements

The information in this press release contains forward-looking statements and information 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 ability of DecisionDx-SCC test results to accurately classify and predict the risk for metastasis in SCC patients with one or more risk factors, help avoid unnecessary treatment and surveillance, allow healthcare providers to increase treatment intensity or follow-up as needed and inform if and when to refer a patient for medical, surgical, or radiation oncology. The words “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “will,” “would” 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, the effects of the COVID-19 pandemic on our business and our efforts to address its impact on our business, subsequent study results and findings that contradict earlier study results and findings, our products’ ability to provide the aforementioned benefits to patients and the risks set forth in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, 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.

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