Esophagus Test TissueCypher® Receives NY State Approval, Announces Castle Biosciences
Castle Biosciences, Inc. (Nasdaq: CSTL), a leading company in providing innovative tests to guide patient care, has announced that its TissueCypher® Barrett’s Esophagus test has been approved by the New York State Department of Health (NYSDOH). This approval represents a significant milestone in the company’s mission to offer precision medicine for better patient care. TissueCypher is the first AI-driven test specifically designed to predict an individual’s risk of progression from Barrett’s esophagus (BE) to esophageal cancer.
Kristen Oelschlager, Chief Operating Officer of Castle Biosciences, expressed pride in the expansion of the company’s New York Clinical Laboratory Permit to include the TissueCypher test. “We are proud of the expansion of our New York Clinical Laboratory Permit to include our TissueCypher test,” she stated. “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.”
Derek Maetzold, President and CEO of Castle Biosciences, added, “The 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 Barrett’s esophagus (BE) in the United States have access to our test.”
TissueCypher is designed to aid clinicians in managing the approximately 5% of adults in the United States who have Barrett’s esophagus. BE is a condition caused by chronic acid reflux that leads to changes in the molecular and cellular structure of the esophagus. BE is the only known precursor to esophageal cancer, which is one of the fastest-growing and deadliest cancers, with a five-year survival rate of only 22%. TissueCypher provides an individual risk assessment by analyzing cancer-associated biomarkers and spatial biology features, identifying molecular signatures of BE progression before visible tissue changes occur. This predictive tool helps clinicians develop a risk-aligned surveillance approach or initiate early interventions to prevent the progression to esophageal cancer.
The TissueCypher test is a precision medicine test designed to predict the future development of high-grade dysplasia (HGD) and/or esophageal cancer in patients diagnosed with Barrett’s esophagus. The test is indicated for use in patients with endoscopic biopsy-confirmed BE, graded as non-dysplastic (NDBE), indefinite for dysplasia (IND), or low-grade dysplasia (LGD). TissueCypher has been validated by 14 peer-reviewed publications of BE progressor patients from leading clinical centers worldwide. The test received Advanced Diagnostic Laboratory Test (ADLT) status from the Centers for Medicare & Medicaid Services (CMS) in March 2022, reinforcing its credibility and utility in clinical practice.
Castle Biosciences has long been committed to providing tests that improve the management of diseases with high clinical need. The company’s current portfolio includes diagnostic tests for skin cancers, Barrett’s esophagus, mental health conditions, and uveal melanoma. Additionally, Castle has active research and development programs aimed at expanding its testing capabilities to other diseases. This includes a test in development for patients diagnosed with moderate-to-severe atopic dermatitis who are seeking systemic treatment.
Through these advancements, Castle Biosciences continues to make strides in transforming disease management. The company’s dedication to developing precise, AI-driven tests like TissueCypher is helping clinicians make more informed decisions, ultimately improving patient outcomes. As Castle expands its offerings, the company aims to continue its focus on delivering tests that provide personalized care to patients in need.
About Castle Biosciences
Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics company focused on improving health through innovative tests that guide patient care. Castle aims to transform disease management by focusing on the needs of patients, clinicians, employees, and investors. The company is committed to providing high-quality, molecular tests designed to inform patient care decisions across multiple medical conditions.
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