Castle Biosciences' TissueCypher Test Approved for Barrett's Esophagus Risk Assessment

Castle Biosciences Achieves Key Milestone with TissueCypher Test Approval

Castle Biosciences, Inc., based in Friendswood, Texas, announces a significant advancement in precision medicine with the full assay approval of its TissueCypher Barrett's Esophagus test from the New York State Department of Health (NYSDOH). This approval represents a major achievement for the company and positions TissueCypher as the first AI-driven test specifically designed to assess the risk of progression from Barrett's esophagus (BE) to esophageal cancer. Kristen Oelschlager, Castle’s Chief Operating Officer, emphasizes that this milestone reflects the company’s dedication to providing high-quality molecular testing that ultimately enhances patient care.

The TissueCypher test is particularly crucial considering the increasing incidence of esophageal cancer, which has a concerning five-year survival rate of only 22%. Approximately 5% of adults in the U.S. are affected by Barrett's esophagus, a condition that can arise from chronic acid reflux and serves as the sole known precursor to esophageal cancer. With the NYSDOH approval, Castle Biosciences can now broaden access to this innovative test for patients diagnosed with non-dysplastic BE, indefinite for dysplasia, or low-grade dysplasia. This expanded access is vital for facilitating timely and informed clinical decisions regarding patient surveillance and potential early interventions.

The TissueCypher test operates by evaluating cancer-associated biomarkers and spatial biology, enabling the establishment of a molecular signature that indicates the likelihood of BE progression. The clinical relevance of this test is strongly supported by 14 peer-reviewed studies, further establishing its efficacy. Additionally, the test received the Advanced Diagnostic Laboratory Test (ADLT) designation from the Centers for Medicare & Medicaid Services (CMS) in March 2022, underscoring Castle Biosciences’ commitment to improving patient outcomes through innovative diagnostics. With this new approval, Castle is poised to make a significant impact in the realm of esophageal cancer prevention and treatment.

In related developments, Castle Biosciences continues to focus on enhancing its diagnostic portfolio. The company remains committed to advancing patient care through innovative molecular testing solutions that address unmet medical needs. As the healthcare landscape evolves, Castle's ongoing dedication to quality and innovation positions it as a leader in precision medicine, particularly in oncology. For more information about the TissueCypher test and Castle Biosciences, visit the company’s website.