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Castle Biosciences' TissueCypher Test Receives New York State Approval for Barrett's Esophagus

• Castle Biosciences has obtained approval from the New York State Department of Health for its TissueCypher Barrett's esophagus test. • TissueCypher is an AI-driven precision medicine test designed to predict the risk of progression from Barrett's esophagus to esophageal cancer. • The test analyzes cancer-associated biomarkers to identify a molecular signature of Barrett's esophagus progression before visible tissue changes. • This approval expands access to TissueCypher for patients with Barrett's esophagus in the United States, enhancing informed care decisions.

Castle Biosciences has announced that its TissueCypher Barrett's esophagus (BO) test has received assay approval from the New York State Department of Health (NYSDOH). This approval signifies that all tests across Castle Biosciences' dermatology, gastroenterology, and ophthalmology portfolios are now approved in New York State.
TissueCypher is designed as an AI-driven precision medicine test to predict a patient’s risk of progression from Barrett’s esophagus to esophageal cancer. Barrett's esophagus, a complication often resulting from gastroesophageal reflux disease (GERD), involves changes to the cellular structure in the esophageal lining, potentially elevating the risk of esophageal cancer. Approximately 5% of the US population is estimated to have BO.
The TissueCypher test analyzes cancer-associated biomarkers to identify a molecular signature indicative of BO progression, potentially preceding visible tissue alterations. It is intended for use in patients with endoscopic biopsy-confirmed BO, classified as non-dysplastic (NDBE), indefinite for dysplasia (IND), or low-grade dysplasia (LGD).
Kristen Oelschlager, Chief Operating Officer at Castle Biosciences, stated, “We are proud of the expansion of our New York Clinical Laboratory Permit to include our TissueCypher test. 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, “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 BO in the United States have access to our test.”
In related news from November 2024, data from Castle Biosciences' DECIDE study indicated that the DecisionDx-Melanoma test led to a 25% reduction in unnecessary sentinel lymph node biopsies among cancer patients.
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Reference News

[1]
Castle Biosciences gains New York state approval for Barrett's oesophagus test
finance.yahoo.com · Jan 6, 2025

Castle Biosciences' TissueCypher Barrett’s oesophagus test, an AI-driven precision medicine test predicting progression ...

[2]
Castle Biosciences gains New York state approval for Barrett's oesophagus test
medicaldevice-network.com · Jan 6, 2025

Castle Biosciences received NYSDOH approval for its AI-driven TissueCypher Barrett’s oesophagus test, predicting progres...

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