On October 13, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported new data from a randomized controlled trial (RCT) showing that use of TissueCypher Barrett’s Esophagus Test results can significantly improve a physician’s accuracy in assessing the risk of progression to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) in patients diagnosed with Barrett’s esophagus (BE), as well as adherence to guideline-recommended patient management strategies (Press release, Castle Biosciences, OCT 13, 2022, View Source [SID1234622003]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
EAC is an aggressive form of esophageal cancer associated with poor outcomes, and the only known precursor condition to its development is BE. TissueCypher is Castle’s precision medicine test designed to predict progression to HGD and/or EAC within five years for patients diagnosed with BE.
"The study data showed that participants who ordered or received TissueCypher test results were up to 65.6% more likely to predict progression to HGD or EAC, (p<0.001), when compared to physicians who did not receive TissueCypher test results in our randomized trial," noted John W. Peabody, M.D., Ph.D., first study author and President of QURE Healthcare. "Importantly, subsequent to receiving test results and making their assessment, the intervention group was also more likely to adhere to guideline-recommended management strategies."
These and other results of the RCT were presented through a moderated poster presentation, titled "Results from a randomized controlled trial: introducing a precision medicine diagnostic tool increases adherence to guidelines in patients with Barrett’s esophagus," shared during the 30th United European Gastroenterology (UEG) Week. The poster may be viewed here.
In the RCT, 259 physicians were randomized to three groups and asked to evaluate clinical performance and value (CPV) vignettes with high- and low-risk patient scenarios based on clinical risk factors. A quality-of-care percentage (0-100%) score was generated from the CPVs based on the American College of Gastroenterology (ACG) and the American Society of Gastrointestinal Endoscopy (ASGE) guidelines. Quality-of-care scores improved significantly across all patient cases after physicians were given the TissueCypher test results.
"Barrett’s esophagus remains a persistent and real-world clinical challenge for endoscopists and patients. Individuals with non-dysplastic Barrett’s esophagus constitute the vast majority of cases, and for years, we have seen few updates in the management strategy of this patient population in particular," said Craig Munroe, M.D., gastroenterology medical director at Castle Biosciences. "We were very excited to present the results of the QURE study, which help further demonstrate TissueCypher’s potential to meaningfully advance the care of this important patient population. We believe the clinical utility and objective information provided by our test can equip physicians with the information they need to make more informed treatment plan decisions and move beyond the limitations in the current standard of care for risk stratification of patients with BE."
About TissueCypher Barrett’s Esophagus Test
The TissueCypher Barrett’s Esophagus test is Castle’s precision medicine test designed to predict future development of high-grade dysplasia (HGD) and/or esophageal cancer in patients with Barrett’s esophagus (BE). TissueCypher is indicated for use in patients with endoscopic biopsy confirmed BE that is graded non-dysplastic (ND), indefinite for dysplasia (IND) or low-grade dysplasia (LGD); its clinical performance has been supported by nine peer-reviewed publications of BE progressor patients with leading clinical centers around the world. The TissueCypher Barrett’s Esophagus Assay is a proprietary Laboratory Developed Test with its own unique CPT PLA code (0108U) and has been on the Medicare Clinical Laboratory Fee Schedule since January 2021. Additionally, the test received Advanced Diagnostic Laboratory Test (ADLT) status from the Centers for Medicare & Medicaid Services (CMS) in March 2022.