Photo: TissueCypher is a precision medicine test designed to predict progression to HGD or ACE in EB patients (Image via Castle Biosciences)
Esophageal cancer (ACE) is one of the fastest growing cancers (by incidence) in the world and is associated with poor outcomes. Chronic gastro-intestinal reflux disease (GERD) is an important risk factor for the development of angiotensin-converting enzyme. Chronic reflux into the esophagus causes changes in the molecular and cellular properties of the esophagus, often resulting in a condition called Barrett’s esophagus (BE). BE is a serious complication of GERD and a risk factor for developing ACE. Currently, gastroenterologists cannot adequately identify BE patients who will develop esophageal cancer. As a result, patients with EB must undergo regular monitoring endoscopy to check the status of the condition. New diagnostic and diagnostic tests are needed to provide practical information to clinicians and patients managing hepatitis B disease.
To date, there is no appropriate method for determining the level of risk in BE patients. No single biomarker can adequately diagnose the degree of dysplasia or predict malignant progression, as 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 had unnecessary endoscopic procedures and have experienced unnecessary anxiety about developing an ACE. Now, new data from a randomized controlled trial (RCT) shows that precision medicine testing can significantly improve a clinician’s accuracy in assessing the risk of progression to high-grade dysplasia (HGD) or CEA in patients diagnosed with BE.
TissueCypher is a precision medicine test from Castle Biosciences (Pittsburgh, PA, USA) that is designed to predict progression to HGD and/or ACE within five years for patients diagnosed with EB. TissueCypher is indicated for use in patients with endoscopic biopsy-confirmed BE classified as non-dysplastic (ND), unspecified dysplastic (IND), or low-grade dysplasia (LGD). At the RCT, 259 physicians were randomly assigned to three groups and asked to rate clinical performance and value (CPV) with patient high-risk and low-risk scenarios based on clinical risk factors. A quality of care score (0-100%) of CPV was obtained according to the American College of Gastroenterology (ACG) and American Society of Gastrointestinal Endoscopy (ASGE) guidelines. The quality of care scores improved significantly in all patients after physicians received the results of the TissueCypher test.
Study data showed that participants who requested or received TissueCypher test results were up to 65.6% more likely to predict progression to HGD or CEA (p < 0.001), compared to clinicians who did not receive TissueCypher test results in our randomized study, Peabody, MD, PhD, first author of the study said. "Importantly, after the test results were received and evaluated, the intervention group was also more likely to adhere to the management strategies recommended by the guidelines."
Barrett’s esophagus remains an ongoing and real clinical challenge for endoscopy specialists and patients. People with non-dysplastic Barrett’s esophagus make up the vast majority of cases, and for years we’ve seen a slight update in the management strategy for this group of patients, said Craig Munro, MD, medical director of gastroenterology at Castle Biosciences. “We were very excited to present the results of the QURE study, which help further demonstrate the potential of TissueCypher in enhancing the care of this important group of patients. We believe that the clinical benefit and objective information provided by our testing can provide clinicians with the information they need to make more informed decisions about a treatment plan. and overcoming the limitations of the current standard of care for risk stratification of patients.
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