Castle Biosciences Receives Advanced Diagnostic Laboratory Test (ADLT) Status for the Barrett TissueCypher® Esophageal Test from the Centers for Medicare & Medicaid Services (CMS)

FRIENDSWOOD, Texas–(BUSINESS WIRE)–Castle Biosciences, Inc. (Nasdaq: CSTL), a company that improves health through innovative tests that guide patient care, today announced that the Centers for Medicare & Medicaid Services (CMS) has granted Advanced Diagnostic Laboratory Test (ADLT) status for the TissueCypher® Barrett’s Esophageal Test, effective March 24, 2022. TissueCypher is Castle’s prognostic test designed to predict the future development of high-grade dysplasia (HGD) and/or esophageal cancer in patients with Barrett’s esophagus (BE).

“Expanding access to Medicare beneficiaries for our innovative portfolio of diagnostic tests is critical as we strive to have a positive impact on patient care,” said Derek Maetzold, President and Chief management of Castle Biosciences. “ADLT status for TissueCypher is an exciting milestone for Castle and an important step in ensuring patients with Barrett’s esophagus have access to our test. This status supports the test’s potential to help prevent esophageal cancer by helping physicians and patients make more informed disease management decisions based on the unique biology of an esophageal biopsy. individual patient.

ADLT status requires that a clinical diagnostic laboratory test provide new clinical diagnostic information that cannot be obtained from any other test or combination of tests, among other criteria.1 The announcement of ADLT status for TissueCypher confirms that the test meets these criteria established by CMS for laboratory testing under the Protecting Access to Health Insurance Act of 2014 (PAMA).

Chronic reflux into the esophagus causes changes in the molecular and cellular characteristics of the esophagus, often resulting in EB. EB is a serious complication of gastroesophageal reflux disease and a risk factor for the development of esophageal cancer, one of the fastest growing cancers (by incidence) in the United States, with a rate of five-year survival of 18.8%.2 The TissueCypher Barrett Esophageal Test is designed to provide clinicians with important information about a patient’s unique risk of esophageal cancer progression based on advanced analysis of biopsy tissue to guide management more personalized and aligned with the risks of BE patients.

TissueCypher is Castle’s fourth test to receive ADLT status, joined by DecisionDx®-UM, DecisionDx®-Melanoma and myPath® melanoma, and has been on the Medicare Clinical Laboratory Fee Schedule (CLFS) since January 2021.

Please visit CMS.gov for more information on PAMA, ADLTs, and the approval of TissueCypher as a new ADLT.

About TissueCypher® Barrett’s esophagus test

The TissueCypher® The Barrett’s Esophageal Test is Castle’s precision medicine test designed to predict the future development of HGD and/or esophageal cancer in patients with EB. The TissueCypher Barrett Esophagus Test is indicated for use in patients with endoscopic biopsy confirmed SE that is classified as non-dysplastic, undefined for dysplasia or low-grade dysplasia; its clinical performance is supported by eight peer-reviewed publications of progressive EB patients with leading clinical centers around the world.

About Castle Biosciences

Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics company that improves health through innovative tests that guide patient care. The Company aims to transform disease management by putting people first: patients, clinicians, employees and investors.

Castle’s current portfolio includes tests for skin cancers, uveal melanoma and Barrett’s esophagus. Additionally, the Company has active research and development programs for testing in other diseases of high clinical need, including its test in development to predict systemic therapeutic response in patients with moderate to severe psoriasis, atopic dermatitis and related conditions. To learn more, visit www.CastleBiosciences.com and connect with us on LinkedIn, Facebook, Twitter and Instagram.

DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, myPath Melanoma, DecisionDx DiffDx-Melanoma, DecisionDx-UM, DecisionDx-PRAME, DecisionDx-UMSeq and TissueCypher are registered 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 “sphere of security” created by these sections. These forward-looking statements include, but are not limited to, statements regarding the potential of the Barrett TissueCypher® Esophageal Test to help prevent esophageal cancer by helping physicians and patients make management decisions. of disease based on the unique biology of a patient’s esophagus. biopsy. The words “anticipate”, “believe”, “estimate”, “expect”, “intend”, “may”, “plan”, “project”, “will”, “would” and Similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain such 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 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 efforts. to cope with its impact. about our business, the results and conclusions of subsequent studies may contradict the results and conclusions of prior studies, including with respect to the discussion of the TissueCypher® Barrett’s Esophagus Test in this press release, the actual application of our tests may not provide the foregoing benefits to patients, and the risks set forth under “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and in our other filings with the SEC. Forward-looking statements speak only as of the date they are made, and we assume no obligation to update forward-looking statements except as required by law.

1Medicare and Medicaid Service Centers: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/Guidance-for-Laboratories-on-ADLTs.pdf

2Esophageal Cancer Action Network, https://ecan.org/facts/