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Castle Biosciences Receives Advanced Diagnostic Laboratory Test (ADLT) Status for TissueCypher® Barrett’s Esophagus Test from the Centers for Medicare & Medicaid Services (CMS)
TissueCypher is Castle’s fourth test to receive ADLT status FRIENDSWOOD, Texas--(BUSINESS WIRE)-- Castle Biosciences, Inc. (Nasdaq: CSTL), a company
About this update from Castle Biosciences, Inc.
[{"type":"text","content":"\nTissueCypher is Castle’s fourth test to receive ADLT status\n\n FRIENDSWOOD, Texas--(BUSINESS WIRE)--\nCastle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that the Centers for Medicare & Medicaid Services (CMS) granted Advanced Diagnostic Laboratory Test (ADLT) status for the TissueCypher® Barrett’s Esophagus test, effective March 24, 2022. TissueCypher is Castle’s prognostic test designed to predict future development of high-grade dysplasia (HGD) and/or esophageal cancer in patients with Barrett’s esophagus (BE).\n\n“Expanding access to Medicare beneficiaries for our innovative portfolio of diagnostic tests is key, as we strive to positively impact patient care,” said Derek Maetzold, president and chief executive officer of Castle Biosciences. “ADLT status for TissueCypher is an exciting milestone for Castle and an important step toward 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 individual patient’s esophageal biopsy.”\n\nADLT 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 tests under the Protecting Access to Medicare Act of 2014 (PAMA).\n\nChronic reflux in the esophagus causes changes to the molecular and cellular features of the esophagus, which often results in BE. BE 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 U.S., with a five-year survival rate of 18.8%.2 The TissueCypher Barrett’s Esophagus test is designed to provide clinicians with important information about a patient’s unique risk of progression to esophageal cancer based on advanced analysis of the biopsy tissue to guide more personalized and risk-aligned management of BE patients.\n\nTissueCypher is Castle’s fourth test to receive ADLT status, joined by DecisionDx®-...