Castle Biosciences Announces Commercial Launch of DecisionDx DiffDx-Melanoma

FRIENDSWOOD, Texas--(BUSINESS WIRE)--Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, today announced that DecisionDx® DiffDx™-Melanoma is now commercially available. DecisionDx DiffDx-Melanoma is designed for use in patients with suspicious pigmented lesions.

“We are pleased to offer DecisionDx DiffDx-Melanoma, which has been designed to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions as benign or malignant,” said Derek Maetzold, president and chief executive officer of Castle. “I am particularly proud of our research and development team, who successfully maintained timelines from program initiation to validation. And employing our artificial intelligence tools, we were able to achieve our target product profile goals for DiffDx-Melanoma: improved accuracy metrics with a substantially reduced intermediate-risk zone, to enable dermatopathologists to act upon a test result from DiffDx-Melanoma. This test has been demonstrated to provide a definitive result in more than 96% of the reported cases, which allows for clinicians to have a greater, direct impact on patient care.”

Sarah I. Estrada, M.D., FCAP, laboratory director of Affiliated Dermatology® added, “Of the approximately 2 million suspicious pigmented lesions biopsied annually in the U.S., approximately 300,000 of those cannot be confidently classified as either benign or malignant through traditional histopathology methods. Undertreatment or delayed identification of melanoma can lead to tumor spread and increased risk of melanoma-specific mortality. On the other hand, overtreatment can impact patient quality of life, potentially resulting in adverse events and increased morbidity. DecisionDx DiffDx-Melanoma is designed to provide diagnostic clarity for dermatopathologists and help dermatologists deliver more informed patient management plans.”

DecisionDx DiffDx-Melanoma is a gene expression profile (GEP) test designed to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions and 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). The intent-to-treat analysis of the DiffDx-Melanoma validation study showed that the test accurately diagnosed malignant and benign cases in 96.6% of the cases with 99.1% sensitivity, 94.3% specificity, 93.6% positive predictive value and 99.2% negative predictive value. An intermediate-risk result was identified in 3.6% of the cases.

Castle has three dermatologic cancer gene expression profile tests commercially available in the U.S.: DecisionDx-Melanoma, DecisionDx-SCC and DiffDx-Melanoma. All three tests were developed in-house by Castle and are validated and supported by multiple peer-reviewed publications.

About DecisionDx DiffDx-Melanoma

DecisionDx® DiffDx™-Melanoma (previously known as ConfirmDx-Melanoma) is designed to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions. Of the 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 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 and 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 DiffDx-Melanoma to add diagnostic clarity and confidence for dermatopathologists and help dermatologists better understand the clinical implications for more informed 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 and our ability to maintain compliance with the covenants in our debt facility, the timing and amount of revenue we are able to recognize in a given fiscal period, unexpected delays in planned launch of our pipeline products, the level and availability of reimbursement for our products, our ability to manage our anticipated growth and the risks set forth in our Annual Report on Form 10-K for the year ended December 31, 2019, filed on March 10, 2020, our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, filed on August 10, 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.