Castle Biosciences Announces New York Approval of DecisionDx® DiffDx™-Melanoma

Rhea-AI Summary

Castle Biosciences (Nasdaq: CSTL) has secured approval from the New York State Department of Health for its DecisionDx® DiffDx™-Melanoma gene expression profile test. This test aims to aid dermatopathologists in diagnosing ambiguous melanocytic lesions. The approval expands the company's diagnostic offerings, which include myPath® Melanoma, enhancing the accuracy of melanoma management. Castle has previously received state approvals for other genomic tests, indicating a robust position in the dermatologic diagnostics market.

Positive

• Approval of DecisionDx® DiffDx™-Melanoma expands diagnostic offerings.
• Enhances accuracy for difficult-to-diagnose melanocytic lesions.
• Previous approvals for multiple genomic tests strengthen market presence.

Negative

• None.

FRIENDSWOOD, Texas--(BUSINESS WIRE)-- Castle Biosciences, Inc. (Nasdaq: CSTL), a dermatologic diagnostics company providing personalized genomic information to improve treatment decisions, today announced that it has received approval from the New York State Department of Health for its proprietary DecisionDx® DiffDx™-Melanoma gene expression profile (GEP) test. DecisionDx DiffDx-Melanoma is designed to provide an objective and comprehensive diagnostic offering to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions.

“We are proud of the expansion of our New York Clinical Laboratory Permit to include the DecisionDx DiffDx-Melanoma test, as it exemplifies our ongoing commitment to providing high-quality, dermatologic genomic tests that can transform care and improve patients’ lives,” said Kristen Oelschlager, chief operating officer of Castle Biosciences. “For patients in New York with ambiguous melanocytic lesions, we believe access to our DecisionDx DiffDx-Melanoma test can provide clarity in the management of their disease for improved overall outcomes.”

In May of 2021, Castle acquired myPath® Melanoma, a clinically validated GEP test designed to be used as an adjunct to histopathology when the distinction between a benign nevus and a malignant melanoma cannot be made confidently by histopathology alone. Together, myPath Melanoma and DecisionDx DiffDx-Melanoma comprise Castle’s comprehensive diagnostic offering for difficult-to-diagnose melanocytic lesions. Both GEP tests, myPath Melanoma and DiffDx-Melanoma, are designed to provide a comprehensive diagnostic workflow that leverages the strengths of both tests for better patient care.

Castle previously received approvals in the state of New York for its other GEP tests, including DecisionDx^®-Melanoma, DecisionDx®-SCC, DecisionDx^®-UM and DecisionDx^®-PRAME, as well as its next generation sequencing panels, DecisionDx^®-CMSeq and DecisionDx^®-UMSeq.

In 2020, Castle doubled the footprint of its College of American Pathologists (CAP) accredited, Clinical Laboratory Improvement Amendments (CLIA)-certified primary laboratory facility located in Phoenix. The Company expanded the space to approximately 23,500 square feet by adding a new laboratory facility in close proximity to its primary facility to support growth and provide certain operational redundancy. Earlier this year, Castle further expanded this facility to include approximately 3,600 additional square feet.

About Castle Biosciences’ Comprehensive Diagnostic Offering for Difficult-to-Diagnose Melanocytic Lesions

Castle Biosciences’ comprehensive diagnostic offering leverages the strengths of myPath® Melanoma and DecisionDx® DiffDx™-Melanoma. These gene expression profile tests are designed to provide a highly accurate, objective result to aid dermatopathologists and dermatologists in characterizing difficult-to-diagnose melanocytic lesions. Of the approximately 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. For these cases, the treatment plan can also be uncertain. Obtaining highly 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 DecisionDx DiffDx-Melanoma are designed to reduce uncertainty and provide confidence for dermatopathologists and help 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 diagnostics 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 (myPath® Melanoma, 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, including its test in development to predict systemic therapy response in patients with moderate to severe psoriasis, atopic dermatitis and related conditions. Castle Biosciences is based in Friendswood, Texas (Houston), and has laboratory operations in Phoenix.

For more information, visit www.CastleBiosciences.com.

DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, myPath Melanoma, DecisionDx DiffDx-Melanoma, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq 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 myPath Melanoma’s and DecisionDx DiffDx-Melanoma’s ability to transform patient care, improve patients’ lives, provide highly accurate, objective results that aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions, and provide a comprehensive diagnostic workflow that leverages the strengths of both tests for better 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, subsequent study results and findings that contradict earlier study results and findings, myPath Melanoma’s and DecisionDx DiffDx-Melanoma’s ability to provide the aforementioned benefits to patients and the risks set forth in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, 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/20210916005136/en/

Investor Contact:

Camilla Zuckero

832-835-5158

czuckero@castlebiosciences.com

Media Contact:

Allison Marshall

amarshall@castlebiosciences.com

Source: Castle Biosciences

FAQ

What is the significance of Castle Biosciences receiving approval for the DecisionDx DiffDx-Melanoma test?

The approval allows Castle Biosciences to offer a new diagnostic tool to aid dermatopathologists in classifying difficult melanocytic lesions, potentially improving patient outcomes.

How does the DecisionDx DiffDx-Melanoma test fit into Castle Biosciences' offerings?

It complements the myPath® Melanoma test, together providing a comprehensive diagnostic workflow for ambiguous melanocytic lesions.

What other tests has Castle Biosciences received approval for in New York?

Castle has approvals for several tests, including DecisionDx®-Melanoma, DecisionDx®-SCC, and DecisionDx®-UM.

How might the DecisionDx DiffDx-Melanoma test impact patient management?

The test can provide clarity in ambiguous cases, helping doctors make more informed treatment decisions, which may lead to better patient outcomes.

What are the market implications of Castle Biosciences' expanded testing capabilities in New York?

With expanded testing capabilities, Castle Biosciences strengthens its position in the dermatologic diagnostics market, potentially increasing its market share and revenues.