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Blinded Independent Validation Study Highlights Effectiveness of Tissue Systems Pathology Test in Predicting Risk of Progression to Esophageal Cancer in Patients with Barrett's Esophagus


Data Presented at DDW 2019 Demonstrate Test Potential to Identify Patients Who May Benefit from Increased Surveillance and Early Therapeutic Intervention 

Cernostics Photo
TissueCypher detects multiple high risk features in a non-dysplastic biopsy from a patient with short segment BE and no visible lesions who progressed to high grade dysplasia 2.5 years later.

PITTSBURGH, PA, May 21, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE – Cernosticsdeveloper of next-generation cancer diagnostics and prognostics, announced today's presentation of positive data from a blinded, independent validation study of its TissueCypher Barrett's Esophagus Assay at  Disease Week® (DDW®) 2019.

Clinicians at Cleveland Clinic and the University of Pittsburgh School of Medicine conducted the study in collaboration with Cernostics, which validated previous findings that a tissue systems pathology test more accurately predicts disease progression risk for patients with Barrett's esophagus (BE) compared with current histology-based risk assessments.

TissueCypher is the first diagnostic test of its kind that predicts the risk of developing esophageal cancer (EC) in patients with BE. The technology uses digitally scanned images of a biopsy to measure and analyze cellular and molecular changes that precede structural changes within the tissue.

"There is an urgent need for improved approaches to stratifying risk in BE patients in order to enable early intervention and prevent disease progression to esophageal cancer," said Prashanthi N. Thota, MD, Director of the Barrett's Center of Excellence at Cleveland Clinic and senior author on the abstract presented at DDW. "Our study results demonstrate that a tissue systems pathology test may provide physicians with additional information that can guide decision-making on surveillance intervals and potential treatment options for their BE patients, potentially leading to improved outcomes."

BE, a serious complication of chronic gastroesophageal reflux disease (GERD), is a risk factor for the development of esophageal cancer (EC), one of the fastest growing and most lethal cancers. Current histopathology methods alone cannot predict if BE will progress to EC. Consequently, BE patients must undergo regular surveillance endoscopies to monitor the status of the condition. TissueCypher Barrett's Esophagus Assay is designed to overcome the limitations of histopathology-based risk assessment methodologies. It is the first test to combine quantitative analysis of multiple protein-based biomarkers with tissue structure information to predict the risk of progression to high-grade dysplasia (HGD) and EC.

The results presented were from a single-blinded, case-control study conducted at two clinical sites. In this study, BE patients who progressed to HGD/EC (incident progressors, n=58) were matched to patients undergoing surveillance with no evidence of progression (non-progressors, n=210). Baseline or pre-progression biopsies from patients with a diagnosis of non-dysplastic (ND), indefinite for dysplasia (IND), or low-grade dysplasia (LGD) BE that was confirmed by a gastrointestinal subspecialist pathologist were tested with TissueCypher in a blinded manner. TissueCypher uses a 3-tier risk classification approach to stratify patients diagnosed with ND, IND or LGD into low-, intermediate- and high-risk classes. Key findings from the study include:

  • There was a significant difference in the probability of progression between patients classified as low risk (n=215) and those classified as high risk by TissueCypher (n=27) (p<0.0001).
  • The highest risk stratification performance of TissueCypher was observed in patients with ND BE.
  • ND BE patients who scored TissueCypher high-risk progressed at a higher rate than patients with a GI subspecialist-confirmed diagnosis of LGD (31.1% within 5 years for ND high-risk vs. 21.8% within 5 years for confirmed LGD).

The study authors conclude that a tissue systems pathology test identifies patients with ND BE who are at increased risk for progression to HGD/EC and may benefit from increased surveillance, and potentially early therapeutic intervention to prevent progression.

"This independent validation of the predictive power of TissueCypher adds to the growing body of clinical evidence supporting this first-of-its-kind test as an important tool for improving the management of BE patients," said Mike Hoerres, Cernostics' CEO. "BE is a known risk factor for EC, a cancer with a rapidly increasing incidence. The ability to better predict the risk of progression should enable early interventions that reduce mortality, improve outcomes and provide more cost-effective management of BE patients."

About Barrett's

BE affects more than three million Americans, occurring when chronic exposure to stomach acid causes the esophageal cell lining to deteriorate and undergo changes that can create an environment for cancer. Without treatment, Barrett's can lead to EC, with a poor 5-year survival of less than 20%. Today, Barrett's is commonly managed by surveillance, involving regular endoscopic procedures with biopsy, monitoring disease progression, and GERD-related drug therapy to control symptoms and prevent esophageal injury.

About Cernostics

Cernostics, a leader in tissue-based diagnostic testing, providing 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


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Lazar Partners

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