Digestive Disease Week® 2021 to Showcase the TissueCypher® Barrett’s Esophagus Assay as a Paradigm-shifting Precision Medicine Tool

·3 min read

Mayo Clinic and AMC Amsterdam to Present Data on Predicting Progression to Esophageal Cancer in Barrett’s Esophagus

Pittsburgh, Pennsylvania, May 17, 2021 (GLOBE NEWSWIRE) -- PITTSBURGH, Pennsylvania, May 17, 2021 – Cernostics (https://www.cernostics.com/) a pioneer in delivering spatialomics to the clinic, announced today that new results from clinical studies on the TissueCypher® Barrett’s Esophagus Assay will be presented at Digestive Disease Week® (DDW®) 2021 taking place May 21-23.

Clinical studies by Mayo Clinic, and Academic Medical Center in The Netherlands, two of the world’s leading academic institutions in the area of diagnosis and treatment of Barrett’s esophagus (BE) and esophageal cancer prevention, will be presented during the oral lecture session focused on predicting progression to esophageal cancer in patients with BE.

“New data accepted for presentation at this year’s DDW® point to the value of TissueCypher® for improving prevention of esophageal cancer, particularly to help physicians and patients make more informed management decisions based on the unique biology of individual patients’ esophageal biopsies,” said Mike Hoerres, Cernostics’ chief executive officer. “We believe such data demonstrate the value of precision medicine testing with the TissueCypher® Barrett’s Esophagus Assay, and greatly appreciate the Barrett’s esophagus clinical experts who led and participated in these studies.”

Below are the details of the presentations on TissueCypher® at DDW® 2021:

TissueCypher Objectively Risk Stratifies Barrett’s Esophagus Patients with Low Grade Dysplasia (lecture presentation)

Presenter: Nicola Frei, MD (AMC, Amsterdam, Netherlands)

Session Title: Prediction of Progression in Barrett's Esophagus

Session Date/Time: May 21, 2021, 10:00 AM to 11:30 AM EDT (UTC –4)

Prediction of Progression in Barrett’s Esophagus Using a Tissue Systems Pathology Test: A Pooled Analysis of International Multicenter Studies (lecture presentation)

Presenter: Prasad Iyer, MD (Mayo Clinic)

Session Title: Prediction of Progression in Barrett's Esophagus

Session Date/Time: May 21, 2021, 10:00 AM to 11:30 AM EDT (UTC –4)

The AMC study, led by Professor Jacques Bergman, MD, PhD, evaluated the performance of the TissueCypher® Barrett’s Esophagus Assay versus the independent scoring of expert and generalist pathologists in the USA and Europe in a cohort of 155 patients previously diagnosed with Low-Grade Dysplasia (LGD) in the community practice setting. TissueCypher® demonstrated higher sensitivity and provided more objective risk stratification than the 12 participating pathologists, as well as identified a subset of progressor patients who had been down-staged to Non-dysplastic BE (ND BE) upon expert review.

The Mayo Study, led by Dr Prasad Iyer, MD, analyzed four independent clinical validation studies (475 patients, including 152 progressors) to assess the performance of TissueCypher® in independently predicting incident progression. The results demonstrated TissueCypher® outperformed the expert pathologist as well as commonly-used clinical variables in risk stratifying patients for progression. Importantly, this study also demonstrated that TissueCypher® can identify high-risk progressor patients diagnosed with ND BE, and therefore can be missed by the standard of care.

Due to the dangers of esophageal cancer and the challenges in identifying those patients who will likely progress to it, the management of Barrett’s esophagus and predicting progression are two of the major Education Tracks in DDW® 2021. Objectively and accurately predicting progression from ND BE to High-Grade Dysplasia (HGD) or esophageal adenocarcinoma (EAC) is critical as the incidence of esophageal cancers is growing at one of the fastest rates of all cancers, and once diagnosed, has extremely low survivability.

About Cernostics and TissueCypher® Barrett’s Esophagus Assay

Cernostics applies spatial biology and biologically aware AI to tissue diagnostics, delivering precision diagnostic testing to patients and gastroenterologists. This technology was used to develop the TissueCypher® Barrett’s Esophagus Assay, the world’s first precision medicine test that predicts future development of esophageal cancer in patients with Barrett’s esophagus. TissueCypher® is a proprietary Laboratory Developed Test (LDT) with its own unique CPT PLA code (0108U), available only from Cernostics’ CLIA-certified pathology laboratory. TissueCypher® has been on the Medicare Clinical Laboratory Fee Schedule since January 2021.

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CONTACT: Ken Troia Cernostics 973-224-8712 ktroia@cernostics.com