Castle Biosciences (CSTL) announced that it has received assay approval from the New York State Department of Health NYSDOH for its TissueCypher Barrett’s Esophagus test. TissueCypher is the first AI-driven precision medicine test designed to predict a patient’s individual risk of progression from Barrett’s esophagus BE to esophageal cancer. “We are proud of the expansion of our New York Clinical Laboratory Permit to include our TissueCypher test,” said Kristen Oelschlager, chief operating officer of Castle Biosciences. “We believe this shift from conditional to full approval by the NYSDOH exemplifies Castle’s commitment to providing high-quality, molecular tests that can guide informed care decisions and improve patients’ lives.” “Successful completion of the rigorous New York state assay review process for TissueCypher, which involves a meticulous review of a test’s analytical validity, clinical validity and clinical utility, is an important step toward ensuring all patients with BE in the United States have access to our test,” added Derek Maetzold, president and chief executive officer of Castle Biosciences.
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