Castle Biosciences Announces New York State Department of Health Approval of Its TissueCypher® Barrett’s Esophagus Test

Original from: business wire

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today 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.

With access to TissueCypher, clinicians have a prognostic tool designed to risk stratify the estimated 5% of adults in the United States with BE.1 Chronic acid reflux from the stomach causes changes to the molecular and cellular features of the esophagus which can result in BE, the only known precursor condition to esophageal cancer. Esophageal cancer is one of the fastest-growing cancers (by incidence) in the United States and one of the deadliest, with a five-year survival rate of just 22%.2 TissueCypher analyzes cancer-associated biomarkers and spatial biology features to identify a molecular signature of BE progression that can precede visible tissue chances in a patient’s esophagus. By providing a patient’s individual risk of progression from BE to esophageal cancer, TissueCypher helps to inform a risk-aligned surveillance approach or earlier interventions that can help prevent the development of cancer.

Source: Castle Biosciences Announces New York State Department of Health Approval of Its TissueCypher® Barrett’s Esophagus Test