Castle Biosciences’ DecisionDx®-Melanoma Test Receives 2022 MedTech Breakthrough Award

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that it has been selected as the winner of the “Best New Technology Solution – Dermatology” award in the sixth annual MedTech Breakthrough Awards program for its innovative DecisionDx®-Melanoma gene expression profile (GEP) test. DecisionDx-Melanoma leverages Castle’s advanced technologies to identify the risk of metastasis, recurrence and sentinel lymph node (SLN) positivity for patients diagnosed with invasive cutaneous melanoma. In 2021, Castle was awarded “Best New Technology Solution – Oncology” by MedTech Breakthrough for its DecisionDx®-SCC and DecisionDx® DiffDx®-Melanoma GEP tests, both of which were launched in the second half of 2020.

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. This year’s program attracted more than 3,900 nominations from over 15 different countries throughout the world.

DecisionDx-Melanoma is Castle’s proprietary risk stratification GEP test that is designed to use a patient’s tumor biology to predict individual risk of metastasis or recurrence for patients diagnosed with invasive cutaneous melanoma, a deadly skin cancer, as well as the risk of SLN positivity, independent of traditional staging factors. Unlike traditional treatment plans that are developed using clinical and pathologic factors alone (e.g., a patient’s age, tumor thickness, ulceration, etc.), incorporating the patient’s primary tissue biology can help physicians and patients make more informed disease management decisions aligned with each patient’s unique biologic risk.

“Having an accurate picture of whether melanoma is likely to recur or spread is critical to making the right treatment and disease management decisions, and though risk indicators like clinicopathological factors and patient history are important, they have their limitations,” said James Johnson, managing director, MedTech Breakthrough. “Genomic testing can supplement these traditional factors, and Castle’s GEP test has been shown to accurately and independently predict individual risk of recurrence or metastasis, and can provide clinically actionable and personalized information to inform the treatment plan for each patient. Congratulations to the Castle team for being our choice for ‘Best New Technology Solution – Dermatology.’”

In 2021, Castle incorporated two new proprietary, independently validated algorithms into its DecisionDx-Melanoma test: i31-SLNB (designed to predict SLN positivity) and i31-ROR (designed to predict an individual patient’s risk of recurrence). These algorithms combine a patient’s clinical and pathologic risk factors with their DecisionDx-Melanoma class result to provide an Integrated Test Result with precise and personalized risk information specific to each patient, including his/her:

• Personalized likelihood of SLN positivity, thus informing consideration of the SLN biopsy surgical procedure.
• Personalized, patient-specific risk of recurrence predictions, including five-year outcomes for melanoma-specific survival, distant metastasis-free survival and recurrence-free survival, to give guidance for patient follow-up and treatment intensity decisions.

“The choices that clinicians and patients make immediately after a diagnosis of invasive melanoma can be critical and ultimately determine the outcome of a patient’s disease,” said Derek Maetzold, president and chief executive officer of Castle Biosciences. “Thus, it was important to us at Castle that our DecisionDx-Melanoma test provided the most precise and personalized information possible to help inform potentially life-changing decisions around the management and treatment of a patient’s cancer. We are thrilled to win this award, recognizing our innovative DecisionDx-Melanoma test that we believe is transforming the management of melanoma and guiding improved patient care.”

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 (CM) metastasis or recurrence, as well as the risk of sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 6,300 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. Additionally, Castle has an ongoing 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 CM cases. This collaboration has resulted in Castle’s analysis of 5,226 samples (clinically tested through December 31, 2018) in a study to evaluate melanoma-specific survival and overall survival; in this study, patients tested with DecisionDx-Melanoma had better survival rates than untested patients, and the data suggested that DecisionDx-Melanoma can accurately risk-stratify for disease progression to aid in risk-aligned treatment plans for improved patient outcomes and survival. 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. Additionally, impact on patient management plans for one of every two patients tested has been shown in five multi-center/single-center studies including more than 800 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 March 31, 2022, DecisionDx-Melanoma has been ordered 97,288 times for patients with cutaneous melanoma.

More information about the test and disease 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, DecisionDx DiffDx-Melanoma, DecisionDx-UM, DecisionDx-PRAME, DecisionDx-UMSeq, TissueCypher and IDgenetix are trademarks of Castle Biosciences, Inc.

About MedTech Breakthrough

Part of Tech Breakthrough, a leading market intelligence and recognition platform for global technology innovation and leadership, the MedTech Breakthrough Awards program is devoted to honoring excellence in medical and health related technology companies, products, services and people. The MedTech Breakthrough Awards provide a platform for public recognition around the achievements of breakthrough health and medical companies and products in categories that include Patient Engagement, mHealth, Health & Fitness, Clinical Administration, Healthcare IoT, Medical Data, Healthcare Cybersecurity and more. For more information visit MedTechBreakthrough.com.

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 ability of GEP testing to accurately and independently predict individual risk of recurrence or metastasis and provide clinically actionable and personalized information to inform patient treatment plans; and our belief that our DecisionDx-Melanoma test is transforming the management of melanoma and guiding improved patient care. The word “can,” “believe” 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 or trial results and findings may contradict earlier study or trial results and findings; 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 March 31, 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.

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