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Two Independent Peer-Reviewed Studies Validate Cernostics’ TissueCypher® Barrett’s Esophagus Assay (TissueCypher®) to Accurately Predict Progression to Esophageal Cancer in Patients with Barrett’s Esophagus

  • SpaT Study confirms TissueCypher®’s ability to identify non-dysplastic Barrett’s Esophagus (NDBE) patients at high risk for progression to cancer who are missed by current standard of care. These “at-risk” NDBE patients progressed at a higher rate (6.9%/year) than patients with expert-confirmed low-grade dysplasia Barrett’s Esophagus (LGDBE).
  • SURF Biomarker Study – TissueCypher® identified approximately 50% of the progressors that were downstaged to NDBE (i.e. missed) by three expert pathologists, as evaluated in the screening cohort of a randomized controlled trial of SUveillance versus RadioFrequency ablation (SURF) for BE patients with community-based diagnosis of low-grade dysplasia (LGD).
  • Both studies reconfirmed a high negative predictive value (NPV) for TissueCypher®  of up to 97.7%, providing a potential path for reducing frequency of surveillance in certain low-risk patients. 

PITTSBURGH, PA November 18, 2020 – Cernostics, Inc. the GI Precision Medicine company, today announced two newly completed clinical studies confirming the ability of the TissueCypher® Barrett’s Esophagus Assay to identify patients at high risk for progression to cancer. The two independent peer-reviewed studies, both authored by Prof. Jacques Bergman and Dr. Nicola Frei (University Medical Center, Amsterdam, the Netherlands), have further validated Cernostics’ TissueCypher® Barrett’s Esophagus Assay to accurately and objectively predict which patients with Barrett’s esophagus will develop esophageal cancer. These studies confirm the accuracy of the assay in patients with NDBE and LGDBE, and support clinical adoption of the assay to help providers make better-informed clinical decisions. TissueCypher® has the potential to improve patient care by identifying patients at high risk for development of esophageal cancer who will benefit from early intervention or increased surveillance, as well as identifying patients at low risk for progression who can avoid unnecessary procedures.

Independent Validation of TissueCypher to Predict Future Progression in Non-Dysplastic Barrett’s Esophagus: A Spatial-Temporal Analysis, published in Clinical and Translational Gastroenterology. This blinded independent validation study confirms the ability of TissueCypher® to accurately predict incident/future progression to esophageal cancer in patients with NDBE. The study also demonstrated that sampling multiple endoscopic levels across the Barrett’s segment further increases the detection rate for NDBE patients at high-risk for incident progression to esophageal cancer. This study validated findings from previous studies that TissueCypher® identifies a high-risk subset of patients with NDBE who progress at a rate that is higher than published estimates for expert pathologist-confirmed LGD. A TissueCypher® high-risk score in patients with NDBE may support a management approach similar to the approach for confirmed LGD, which includes endoscopic eradication therapy or increased surveillance to prevent development of cancer. This is a crucial finding as these are the “at-risk” group who may be missed by the current standard of care. This is the fourth study to independently validate the TissueCypher® assay, and provides a critical level of evidence to support clinical adoption of the assay to risk stratify patients with non-dysplastic BE.

Tissue Systems Pathology Test Objectively Risk Stratifies Barrett’s Esophagus Patients with Low-Grade Dysplasia, accepted in American Journal of Gastroenterology This blinded cohort study evaluated the TissueCypher® Barrett’s Esophagus Assay in the screening cohort of a randomized controlled trial of SUveillance versus RadioFrequency ablation (SURF) for BE patients with community-based diagnosis of LGD. This is the fifth study to independently validate the risk stratification of TissueCypher®, and a key strength is the study design in which the cohort was prospectively enrolled and followed. The results independently validated the ability of TissueCypher® to objectively risk-stratify patients with LGD. TissueCypher® provided objective risk stratification, whereas there was significant variability between the expert pathologists whose diagnoses were concordant for only 51.7% of cases in this study. In addition to risk stratifying patients with expert pathologist-confirmed LGD, TissueCypher® also identified approximately 50% of the progressors that were downstaged to NDBE by expert pathologists. These patients are a high-risk subset who may be missed by the current standard of care, but could be identified early by TissueCypher® and undergo management similar to LGD to prevent progression to cancer.

“Key opinion leaders from around the world continue to validate the potential for TissueCypher® to improve care for patients with Barrett’s esophagus,” commented Cernostics CEO Mike Hoerres. “We appreciate Prof. Jacques Bergman’s continued commitment to evaluating our innovative technology, and we anticipate additional studies from thought-leading institutions in the coming months that further validate the unique ability of TissueCypher® to predict progression in patients with BE. Our momentum in growing clinical evidence and adoption bodes well for patients afflicted with this disease state and their physicians.”

About Barrett’s Esophagus and TissueCypher®

Barrett’s esophagus, which affects more than three million Americans, occurs when chronic exposure to acid from the stomach causes the esophageal cell lining to deteriorate, creating an environment for cancer. Without treatment, BE can lead to esophageal adenocarcinoma, the fastest-rising cancer in the U.S. The current approach to managing BE is surveillance, involving regular endoscopic procedures with biopsies, monitoring for disease progression, and GERD-related drug therapy to control symptoms and prevent injury to the esophagus. Cernostics has developed and commercialized the world’s first precision medicine test that predicts risk of developing esophageal cancer in patients with Barrett’s esophagus. The patent-protected technology platform – TissueCypher® Barrett’s Esophagus Assay – uniquely analyzes whole slide digital images with multiplexed fluorescence, providing greater information and accuracy than traditional subjective tissue diagnostics. TissueCypher® provides actionable information to gastroenterologists, eliminating the uncertainty related to the management of Barrett’s esophagus patients.

About Cernostics

Cernostics, a leader in tissue-based diagnostic testing, provides diagnostic tests with deeper tissue insights, better patient outcomes and lower cost of care. Cernostics’ mission is to quantify the tissue system complexity, providing physicians and patients with individualized, actionable information to improve outcomes and reduce the incidence and mortality of cancer. For a complete listing of Cernostics’ published patents, visit www.cernostics.com/IP.

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