Presentations to highlight two of Castle’s skin cancer gene expression profile tests
Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, today announced that the company will deliver two poster presentations at The American Society of Dermatopathology (ASDP) 57th Virtual Annual Meeting, to be held on Nov. 5 – 11, 2020.
Presentation details are as follows:
Poster #: 592
Title: Identifying predictors of sentinel lymph node metastasis in cutaneous melanoma patients using molecular and clinicopathologic high-risk features
Session: Oral & Poster Abstract Defense 2
Presenter: Federico Monzon, M.D.
Date: Tuesday, November 10, 2020
Time: 11:30 a.m. – 12:30 p.m. Central time
Poster #: 296
Title: Development and validation of a diagnostic gene expression profile test for ambiguous or difficult to diagnose pigmented skin lesions
Session: Oral & Poster Abstract Defense 1
Presenter: Sarah Estrada, M.D., FCAP
Date: Monday, November 9, 2020
Time: 11:00 a.m. - 12:00 p.m. Central time
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. Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter studies that included more than 3,000 patients. 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 June 30, 2020, DecisionDx-Melanoma has been ordered more than 59,900 times for use in patients with cutaneous melanoma.
More information about the test and disease can be found at www.SkinMelanoma.com.
About Suspicious Pigmented Lesions
In the U.S., approximately 2 million skin biopsies of pigmented or melanocytic lesions are performed annually, which Castle estimates leads to the diagnosis of 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 of these 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 improvements in patient care and demand for a test for suspicious pigmented lesions. 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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