On April 27, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported an independent, peer-reviewed article published in Clinical Gastroenterology and Hepatology (Press release, Castle Biosciences, APR 27, 2022, View Source [SID1234613067]). The study, which can be viewed here, reinforces the ability of TissueCypher to significantly improve predictions of progression to esophageal cancer in patients with Barrett’s esophagus (BE), compared to predictions based on clinical and pathology variables alone, allowing for more informed disease management decisions.
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"One of the most critical challenges in the management of the nearly 384,000 patients with Barrett’s esophagus who undergo an endoscopy each year is determining which are at risk of progression to esophageal cancer," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "In this study, TissueCypher outperformed expert pathologist evaluations, which relied solely on commonly used clinical and pathologic variables, in risk-stratifying patients for progression, particularly those at highest risk of developing esophageal cancer."
"Of particular importance in this study was the ability of the test to identify high-risk patients who progressed to high-grade dysplasia (HGD) or esophageal cancer, yet were initially diagnosed as non-dysplastic BE (NDBE)," said Prasad G. Iyer, M.D., M.Sc., lead study author and professor of medicine in the Barrett’s Esophagus Unit of the Division of Gastroenterology and Hepatology at the Mayo Clinic, Rochester, Minn. "In clinical practice, the majority of BE patients who develop esophageal cancer are diagnosed as NDBE at their baseline endoscopy. Many of these are missed by traditional standard of care, and importantly, miss the opportunity of early interventions that could potentially prevent their progression to the highly lethal esophageal cancer, or at a minimum, increase their chances of survival."
"TissueCypher has the potential to help change this," added Maetzold.
In the manuscript titled, "Prediction of Progression in Barrett’s Esophagus Using a Tissue Systems Pathology Test: A Pooled Analysis of International Multicenter Studies," Iyer et al. at Mayo Clinic and Case Western Reserve University evaluated the risk-stratification performance of TissueCypher using patient-level data from five published clinical validation studies that included a total of 552 patients with BE.
In the study, 51.8% (n=58) of the 112 patients diagnosed as NDBE who progressed to HGD or esophageal cancer received an intermediate- or high-risk TissueCypher score, representing a sensitivity of 52% in detecting this subset of progressors who are often missed by the current standard of care. Further, a TissueCypher high-risk score was associated with a strong (Odds Ratio (OR)=14.3) independent risk of progression in NDBE patients. When incorporated with expert pathologist review and clinical risk variables, TissueCypher was associated with further improved risk predictions versus those made without the test’s results (c-statistic=0.72 with TissueCypher versus 0.63 without, p<0.0001).
In the study, a TissueCypher high-risk score independently predicted increased risk of progression to HGD/esophageal cancer (OR=6.0, 95% Confidence Interval (CI)=2.99-12.01, p<0.001), with improved accuracy over expert pathologist diagnoses of low-grade dysplasia (LGD) (OR=2.92, 95% CI=1.18-7.24, p<0.021) and indefinite for dysplasia (IND) (OR=2.13, 95% CI=0.76-5.99, p=0.15). Additionally, when the TissueCypher score was incorporated with expert pathologist review of biopsied tissue and other clinical risk variables, the risk prediction accuracy was significantly improved (c-statistic=0.75 with TissueCypher versus 0.68 without, p<0.0001), which suggests that TissueCypher can be added into existing clinical care plans to help guide more personalized and risk-aligned management of BE patients.
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). The TissueCypher Barrett’s Esophagus test is indicated for use in patients with endoscopic biopsy confirmed BE that is graded non-dysplastic (NDBE), indefinite for dysplasia (IND) or low-grade dysplasia (LGD); its clinical performance has been supported by eight 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.