TissueCypher® Barrett’s Esophagus Assay is the world’s first precision medicine test that predicts future development of esophageal cancer in patients with Barrett’s esophagus.
The test is intended for patients with pathology diagnosis of non-dysplastic Barrett’s esophagus (NDBE), indefinite for dysplasia (IND), or low-grade dysplasia (LGD).
Background on Barrett’s Esophagus and Esophageal Cancer
Esophageal cancer is one of the fastest-growing cancers (by incidence) in the world. The incidence of this once rare cancer has increased by more than 500% since the 1970s. Esophageal cancer remains highly lethal, with a 5-year survival rate of 18%. This dramatic increase in esophageal cancer incidence closely tracks with increases in obesity and chronic gastrointestinal reflux (GERD) in western countries, and these are major risk factors for the development of esophageal cancer.
Chronic reflux in the esophagus causes changes to the molecular and cellular features of the esophagus, which often results in a condition called Barrett’s esophagus. Barrett’s is a serious complication of GERD and a risk factor for the development of esophageal cancer. Today, gastroenterologists cannot adequately determine which patients with Barrett’s esophagus will progress to esophageal cancer. As a result, patients with Barrett’s must undergo regular surveillance endoscopies to check the status of the condition. New diagnostic and prognostic tests are needed to provide actionable information to physicians and patients managing Barrett’s esophagus.
Histopathology Alone Can’t Predict Whether BE Will Progress to EAC
Until now, there has been no adequate way to determine the risk level of patients with Barrett’s esophagus. There is no single biomarker that can sufficiently diagnose the grade of dysplasia or predict malignant progression since multiple pathways play a role in disease progression. As a result, many high-risk patients do not receive the intervention they need, while low-risk patients have undergone unnecessary surveillance endoscopies and experienced needless anxiety about developing EAC.
The Science Behind TissueCypher®
Cancer is a System, Not a Single Cell Type
Tumors are composed of many interacting cell types, including malignant cells, immune cells such as macrophages, stromal cells such as fibroblasts and endothelial cells, as well as cancer stem cells. All of these cell types impact cancer development, tumor progression, responses to therapy, and ultimately, patient outcomes. The majority of cancer diagnoses are currently made by pathologists viewing tissues on glass slides via light microscopy (anatomic pathology). While valuable, this approach is focused on the morphology of malignant cells and is limited in its ability to evaluate multiple biomarkers and cell types within the tumor system.
The Science that Drives the TissueCypher® Platform
Castle Biosciences’ technology approach objectively measures optimal combinations of epithelial, immune, and stromal processes in the context of tissue morphology to extract tissue profiles (information from digital whole side images of tissue biopsies) that are correlated with diagnosis and prognosis. Our tissue systems biology approach integrates the expression results of multiple biomarkers and morphology on small tissue samples.