Castle Biosciences Recognized for Skin Cancer Diagnostics Innovation in 2021 MedTech Breakthrough Awards Program

Castle Biosciences develops and commercializes diagnostic and prognostic tests for dermatologic cancers. The Company’s tests are designed to provide clinically actionable, tumor-specific genomic information to enable more accurate skin cancer treatment plan decisions. Castle believes that the traditional approach to developing a treatment plan for dermatologic cancers using clinical and pathology factors alone can be improved by incorporating personalized genomic information.

In 2020, Castle launched two new genomic tests designed to improve the management of skin cancer, DecisionDx-SCC and DecisionDx DiffDx-Melanoma. DecisionDx-SCC is the Company’s proprietary gene expression profile (GEP) test that is designed to predict the risk of metastasis for patients with cutaneous squamous cell carcinoma who have one or more risk factors. DecisionDx DiffDx-Melanoma is designed to provide a highly accurate, objective result to aid dermatopathologists and dermatologists in characterizing suspicious pigmented lesions. Castle believes these two recently launched tests complement Castle’s GEP test for invasive cutaneous melanoma, DecisionDx^®-Melanoma, which is a proprietary GEP test that uses an individual patient’s tumor biology to predict risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity independent of traditional staging factors.

The mission of the MedTech Breakthrough Awards is to honor excellence and recognize the innovation, hard work and success in a range of health and medical technology categories, including Robotics, Clinical Administration, Telehealth, Patient Engagement, Electronic Health Records (EHR), mHealth, Medical Devices, Medical Data and many more. This year’s program attracted more than 3,850 nominations from over 17 different countries throughout the world.

“Skin cancers continue to be the most commonly diagnosed cancers, with around 5.5 million new cases diagnosed annually in the U.S., and Castle is addressing this challenge head-on,” said James Johnson, managing director, MedTech Breakthrough. “When individualized genomic information is incorporated with traditional clinical and pathology factors used to assess risk, physicians and patients can make more informed treatment decisions, in line with each patient’s risk. Castle is driving innovation in this space, and we are thrilled to recognize Castle in our 2021 MedTech Breakthrough Awards program.”

“The approach that physicians traditionally use to determine risk--reviewing clinical and pathological factors like patient history and pathology lab results— is necessary and lifesaving. But adding personalized, precise genomic information to predict the likelihood of any individual’s skin cancer’s future spread or return, or for aiding clinicians with difficult-to-diagnose potential melanoma cases, has the potential to improve patient care,” said Derek Maetzold, president and chief executive officer at Castle Biosciences. “We developed DecisionDx-SCC and DecisionDx® DiffDx-Melanoma to answer this significant unmet medical need in skin cancer management, and we are thrilled to receive this 2021 MedTech Breakthrough Award in recognition of our innovation in this breakthrough approach and technology to support it.”

About Castle Biosciences

Castle Biosciences (Nasdaq: CSTL) is a commercial-stage dermatologic cancer 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. 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.

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 December 31, 2020, DecisionDx-Melanoma has been ordered more than 68,920 times for use in patients with cutaneous melanoma.

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

About DecisionDx DiffDx-Melanoma

DecisionDx® DiffDx™-Melanoma is designed to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions. Of the approximately 2 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. DecisionDx DiffDx-Melanoma classifies these lesions as: benign (gene expression profile suggestive of benign neoplasm); intermediate-risk (gene expression profile cannot exclude malignancy); or malignant (gene expression profile suggestive of melanoma). Interpreted in the context of other clinical, laboratory and histopathologic information, DecisionDx DiffDx-Melanoma is designed to add diagnostic clarity and confidence for dermatopathologists while helping dermatologists deliver more informed patient management plans.

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, 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.

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 and Decision Dx DiffDx-Melanoma test results to improve treatment plans for dermatologic cancers, add personalized, precise genomic information, predict the likelihood of any individual’s skin cancer’s future spread or return, aid clinicians with difficult-to-diagnose potential melanoma cases and improve patient care. 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 Annual Report on Form 10-K for the year ended December 31, 2020, 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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