ConfirmDx-Melanoma is Castle’s gene expression profile test for suspicious pigmented lesions
Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, today announced that it will host an investor webcast on Oct. 28, 2020, at 4:30 p.m. Eastern time, to highlight the planned launch of the ConfirmDx®-Melanoma test, which will be commercially available in the fourth quarter of 2020. ConfirmDx-Melanoma is designed for use in patients with difficult-to-diagnose suspicious pigmented (melanocytic), lesions.
Castle’s ConfirmDx-Melanoma test is designed to aid dermatopathologists in characterizing difficult-to-diagnose pigmented 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. ConfirmDx-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 malignant melanoma). Interpreted in the context of other clinical, laboratory and histopathologic information, ConfirmDx-Melanoma is designed to add diagnostic clarity and confidence for dermatopathologists, while helping dermatologists better understand the clinical implications for more informed patient care.
Conference call and webcast details can be found below:
Castle Biosciences ConfirmDx-Melanoma Investor Webcast
October 28, 2020
4:30 p.m. ET
US/Canada Participant Toll-Free Dial-in number: (877) 282-2581
US/Canada Participant International Dial-in number: (470) 495-9137
The webcast will include Sarah I. Estrada, M.D., FACP, laboratory director, Affiliated Dermatology®, as a guest speaker. There will be a brief Question & Answer session following management commentary.
A live webcast of the conference call can be accessed here https://edge.media-server.com/mmc/p/kp7dtonx or via the webcast link on the Investor Relations page of the Company’s website (www.castlebiosciences.com). Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until Nov.18, 2020.
About Suspicious Pigmented Lesions
In the U.S., approximately 2 million skin biopsies of pigmented or melanocytic lesions are performed annually, leading to the diagnosis of an estimated 130,000 invasive melanoma cases and more than 96,000 in situ melanoma cases. These biopsies are typically pigmented lesions for which the healthcare provider suspects melanoma. The majority of these biopsies receive a definitive diagnosis by the dermatopathologist using traditional microscopic analyses. However, approximately 300,000 biopsies are considered difficult-to-diagnose using this traditional method and require additional testing to clarify the likelihood that this lesion is benign or malignant. And though there are several options for further testing, Castle believes there is a need for improvements in objective tests to resolve this diagnostic dilemma.
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; www.SkinMelanoma.com), cutaneous squamous cell carcinoma (DecisionDx®-SCC, www.MySCCSkinCancer.com) and uveal melanoma (DecisionDx®-UM, DecisionDx®-PRAME and DecisionDx®-UMSeq; www.MyUvealMelanoma.com). Castle also has products in development for other underserved cancers, the most advanced of which is focused on patients who have a difficult-to-diagnose pigmented lesion. 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-UM, DecisionDx-PRAME and DecisionDx-UMSeq and are trademarks of Castle Biosciences, Inc.
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 anticipated commercial availability of ConfirmDx-Melanoma and the ability of ConfirmDx-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.
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