Castle Biosciences Announces Receipt of New York Laboratory Permit

By: Castle Biosciences, Inc. via Business Wire

June 09, 2021 at 07:00 AM EDT

Castle Biosciences, Inc. (Nasdaq: CSTL), a dermatologic diagnostics company providing personalized genomic information to inform treatment decisions, today announced that it has received approval from the New York State Department of Health for its DecisionDx-SCC test. DecisionDx-SCC is Castle’s gene expression profile (GEP) test designed to use a patient’s tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. Previous studies have demonstrated that the test is a significant, independent predictor of risk compared to existing traditional clinical and pathologic staging systems.

Being a permitted laboratory in the state of New York allows patients in that state to access the Company’s molecular diagnostic tests, designed to provide actionable molecular information to inform patient care decisions. The Company has previously received approvals in the state of New York for its other genomic tests, DecisionDx^®-Melanoma, DecisionDx^®-UM and DecisionDx^®-PRAME, as well as its next generation sequencing panels, DecisionDx^®-CMSeq and DecisionDx^®-UMSeq.

“With the expansion of our New York Clinical Laboratory Permit to include our DecisionDx-SCC test, patients in New York will now have access to personalized genomic information, which physicians can use to make more informed choices for patients’ treatment and follow-up care,” said Kristen Oelschlager, chief operating officer of Castle Biosciences. “The approval process in New York is rigorous and includes both a physical laboratory inspection and an extensive review of the test’s validation data. This approval reflects our continued commitment to the highest standards in laboratory medicine.”

“As we continue to grow our suite of genomic tests addressing dermatologic conditions with high clinical need, each milestone is important in the advancement of patient care, including our recent accreditation for the DecisionDx-SCC test in the state of New York,” said Derek Maetzold, president and chief executive officer of Castle Biosciences. “We are proud that our DecisionDx-SCC test is now available for more patients with squamous cell carcinoma (SCC) to help guide their overall risk assessment and disease management decisions.”

Castle’s laboratory operations are located in Phoenix, and in 2020, the Company doubled the footprint of its College of American Pathologists (CAP) accredited, Clinical Laboratory Improvement Amendments (CLIA)-certified primary laboratory facility. 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 in 2021, Castle further expanded this facility to include approximately 3,600 additional square feet.

About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1, 2A or 2B risk category, predicts individual metastatic risk to inform risk-appropriate management.

Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management.

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 (DecisionDx^®DiffDx™-Melanoma, myPath® 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. Additionally, in May of 2021, Castle acquired the myPath Melanoma laboratory in Salt Lake City.

For more information, visit www.CastleBiosciences.com.

DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, DecisionDx DiffDx-Melanoma, myPath 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 the ability of DecisionDx-SCC test results to predict the risk for metastasis in SCC patients with one or more risk factors and provide actionable molecular information to inform patient care decisions, and statements concerning the availability and access to the DecisionDx-SCC test in the state of New York. 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, our product’s ability to provide the aforementioned benefits to patients, loss of one or more approvals in the state of New York or by other regulatory bodies and the risks set forth in our Quarterly Report on Form 10-Q for the quarter ended March 31, 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.