New TissueCypher® Validation Study identifies high risk Barrett's Esophagus patients who are 46x more likely to have cancer at time of biopsy

BETHLEHEM, Pa., Oct. 11, 2016 /PRNewswire-USNewswire/ -- A recent study published in the electronic issue (October) of the journal Cancer Epidemiology, Biomarkers and Prevention provides further validation to support the clinical use of TissueCypher^® Barrett's Esophagus Assay (TissueCypher^®), developed by Cernostics, Inc., a leader in tissue-based diagnostics. Results show that TissueCypher^® identifies high risk Barrett's esophagus (BE) patients who are 46x (odds ratio from the study) more likely to have either high grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) at the time of biopsy vs. BE patients who scored low risk with TissueCypher.¹  

"This study is an important step forward in our ability to more accurately risk-stratify patients with Barrett's Esophagus, which will ultimately lead to improved physician decision making, and more optimal surveillance of patients with Barrett's Esophagus," stated Dr. Prateek Sharma, Gastroenterologist with the University Of Kansas Medical Center, who was not affiliated with the study.

The study concluded that the tissue systems pathology test (TissueCypher^®) better predicts presence of prevalent HGD and EAC in Barrett's esophagus patients vs. standard pathology testing. TissueCypher demonstrated high accuracy in detecting the presence of prevalent HGD and EAC, even in biopsies with a pathologic diagnosis of non-dysplastic intestinal metaplasia (non-dysplastic Barrett's Esophagus). Barrett's Esophagus is a major risk factor for developing HGD and EAC².

TissueCypher^® is the first diagnostic test of its kind that predicts the risk of developing esophageal cancer in patients with Barret's Esophagus. The technology uses digitally scanned images of a biopsy to measure and analyze cellular and molecular changes that precede structural changes within the tissue.

The study, which was conducted with leading medical institutions; University of Pittsburgh, Geisinger Health System, University of Pennsylvania and the Academic Medical Center, located in Amsterdam, evaluated 175 patients with BE, including 30 patients with confirmed HGD or EAC.

Expert endoscopy centers have higher rates of detection of HGD/EAC than community centers, but detection of subtle lesions can be challenging in all settings. The study's key finding of stronger predictive power using the TissueCypher^® technology showed that the test's deeper tissue interrogation properties provide a high level of accuracy regarding the patient's probability of harboring prevalent HGD or cancer. The finding suggests that objective detection of abnormalities in the preneoplastic field (pre-cancer field) of BE could overcome some of the limitations of random biopsy sampling and subjective pathologic diagnoses, and facilitate earlier detection and treatment of HGD and esophageal cancer in both expert referral and community practice settings.

It is estimated that 17 million people in the U.S. have confirmed Barrett's esophagus². The need for accurate diagnostic and prognostic tools for patients with Barrett's esophagus is a result of the growing incidence rate of esophageal cancer, which is one of the fastest growing cancers in the world (by incidence^{) 3}, with a 5-year survival rate of only 18%^.4.

The publication of this study comes on the heels of a recent meta-analysis study from the Mayo Clinic, which showed that more than 1,400 patients across multiple studies had either missed HGD or EAC at baseline, or progressed to HGD or EAC within three years of biopsy⁵.

ABOUT CERNOSTICS
Cernostics is a leader in tissue-based diagnostic testing, providing diagnostic tests with deeper tissue insights, better patient outcomes and lower cost of care. Our mission is to quantify the complexity of the tissue system, providing physicians and patients with individualized, actionable information to improve outcomes and reduce the incidence and mortality of cancer.

Our proprietary technology platform, TissueCypher^®, uniquely analyzes whole slide digital images and is designed to provide greater information and accuracy than traditional tissue diagnostics. Cernostics' lead product, the TissueCypher^® Barrett's Esophagus Assay, delivers the most comprehensive evaluation of esophageal cancer risk for Barrett's Esophagus patient's currently available, providing actionable information to gastroenterologists, pathologists, and patients. For more information, visit www.cernostics.com.

^*Study included 30 patients with prevalent HGD or EAC (cancer) confirmed on repeat endoscopy and 145 patients with clinical outcome data demonstrating no progression to HGD or EAC.

^1. Critchley-Thorne, RJ, et.al., A Tissue Systems Pathology Detects Abnormalities Associated with Prevalent High Grade Dysplasia and Esophageal Cancer in Barrett's Esophagus, Cancer Epidemiol Biomarkers Prev. 2016 epub ahead of print.
^2. Pohl H and Welch HG. J Natl Cancer Inst 2005; 95:142-146; Brown et al., J Natl Cancer Inst. 2008;100:1184–1187
^3. Hayeck TJ, Kong C, Spechler S.J, Gazelle G S, Hur C. The prevalence of Barrett's esophagus in the US: estimates from a simulation model confirmed by SEER data. Dis Esophagus. 2010;23(6):451-457.
^4. Cancer Facts & Figures 2014 American Cancer Society 2014
^5. Visrodia, K, et al. Magnitude of Missed Esophageal Adenocarcinoma After Barrett's Esophagus Diagnosis: A Systemic Review and Meta-analysis. Gastroenterology, 150: 599-607, 2016

Contact: Josh Weinstein for Cernostics or Jennifer May for Cernostics
610.438.8853 / 412-656-8192
[email protected] / [email protected]

SOURCE Cernostics, Inc.