Castle Biosciences Presents Case Study Showcasing the Diagnostic Performance of DiffDx®-Melanoma at the College of American Pathologists 2022 (CAP22) Annual Meeting

Rhea-AI Summary

Castle Biosciences (Nasdaq: CSTL) presented a poster at the CAP22 Annual Meeting showcasing its DiffDx-Melanoma test, which demonstrated over 98% accuracy in diagnosing melanocytic lesions. The test supports decisions for local excision in challenging cases where traditional methods are inconclusive. The company’s gene expression profile tests aim to aid dermatologists in providing confident treatment plans for approximately 300,000 ambiguous lesions annually in the U.S. Detailed case study results are available in the presented poster.

Positive

• DiffDx-Melanoma demonstrated over 98% accuracy in clinical testing.
• The poster presentation at CAP22 highlights the test's effectiveness in supporting local excision decisions.
• Castle aims to reduce uncertainty in diagnosing melanocytic lesions, aiding clinicians.

Negative

• None.

Poster presentation given by Harold Rabinovitz, M.D., Professor of Dermatology at the Medical College of Georgia in Augusta, Georgia

FRIENDSWOOD, Texas--(BUSINESS WIRE)-- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced a recent poster presentation showcasing the performance of its diagnostic gene expression profile (GEP) test, DiffDx^®-Melanoma. Castle’s diagnostic GEP tests, DiffDx^®-Melanoma and MyPath^® Melanoma, are designed to aid in the diagnosis of ambiguous melanocytic lesions and have been shown to provide objective, clinically actionable results in more than 98% of lesions tested. In the case study presented during the College of American Pathologists 2022 (CAP22) Annual Meeting, DiffDx-Melanoma supported the need to perform a local excision on a difficult-to-diagnose melanocytic lesion after clinicopathological correlation was not achieved by dermoscopy, reflectance confocal microscopy and/or histopathological assessment alone.

“Dermatologists have several diagnostic tools at their disposal, including dermoscopy and reflectance confocal microscopy, to evaluate the malignant potential of suspicious pigmented lesions; however, there are times when histopathologic evaluations may not agree with the malignant potential of a lesion as assessed clinically,” said Rabinovitz. “Castle’s DiffDx-Melanoma test is a highly accurate ancillary test that can provide additional diagnostic information, as shown through the case study presented, that can help clinicians determine the appropriate next steps in a patient’s overall care.”

Details of the case study are available in a poster titled “Diagnostic Differentiation between Evolving Melanoma In Situ or Unusual Clark’s Nevus with the 35-Gene Expression Profile Test.” The poster can be viewed here.

About MyPath^® Melanoma and DiffDx^®-Melanoma

MyPath Melanoma and DiffDx-Melanoma are Castle’s two gene expression profile tests designed to provide an accurate, objective result to aid dermatopathologists and dermatologists in characterizing difficult-to-diagnose melanocytic lesions. Of the approximately two 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. For these cases, the treatment plan can also be uncertain. Obtaining accurate, objective ancillary testing can mean the difference between a path of overtreatment or the risk of undertreatment. Interpreted in the context of other clinical, laboratory and histopathologic information, MyPath Melanoma and DiffDx-Melanoma are designed to reduce uncertainty and provide confidence for dermatopathologists and help dermatologists deliver more informed patient management plans.

More information about Castle’s tests 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, DiffDx-Melanoma, DecisionDx-UM, DecisionDx-PRAME, DecisionDx-UMSeq, TissueCypher and IDgenetix are trademarks of Castle Biosciences, Inc.

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 our DiffDx-Melanoma test to provide additional diagnostic information that can help clinicians determine the appropriate next steps in a patient’s overall care. The word “can” 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: subsequent study or trial results and findings may contradict earlier study or trial results and findings or may not support the results obtained in this study, including with respect to the discussion of DiffDx-Melanoma in this press release; 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 June 30, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221011005300/en/

Investor Contact:

Camilla Zuckero

czuckero@castlebiosciences.com

Media Contact:

Allison Marshall

amarshall@castlebiosciences.com

Source: Castle Biosciences, Inc.

FAQ

What is the significance of the DiffDx-Melanoma test presented by Castle Biosciences?

The DiffDx-Melanoma test has shown over 98% accuracy in diagnosing melanocytic lesions, helping clinicians make informed decisions.

What was discussed in the recent poster presentation by Castle Biosciences?

The poster presentation at the CAP22 Annual Meeting focused on the efficacy of DiffDx-Melanoma in differentiating between melanoma and other lesions.

How does Castle Biosciences assist dermatologists in patient care?

Castle Biosciences provides gene expression profile tests that offer objective results, enhancing clinicians' ability to diagnose and manage skin lesions.

What is the annual impact of ambiguous melanocytic lesions in the U.S. according to Castle Biosciences?

Approximately 300,000 of the 2 million suspicious pigmented lesions biopsied annually in the U.S. cannot be confidently classified through traditional methods.