Gastroenterologists are usually quick to admit they do not have a good way to manage patients with Barrett’s esophagus. They know Barrett’s is a precursor to esophageal cancer, but they don’t have a great way of predicting which Barrett’s patients are likely to progress to esophageal cancer and which patients probably won’t develop the cancer.


Cernostics (Pittsburgh), a young company taking a tissue systems biology approach to anatomic pathology, is trying to address this clinical challenge with its TissueCypher platform technology.


The first application of the technology will be to provide comprehensive risk prediction for the development of esophageal cancer in patients with Barrett’s esophagus.


CEO Mike Hoerres told Medical Device Daily that the TissueCypher platform is designed to evaluate hundreds of unique features on a Barrett’s biopsy, providing a better way to predict which patients will progress to either high-grade dysplasia or cancer.


Hoerres said the GI doctors his company has talked to want two things when it comes to Barrett’s patients: one, a rule-out test to tell them which patients are not likely to progress and do not need aggressive treatment and surveillance; and second, a rule-in test to tell them which patients need the more aggressive treatment and surveillance because of a higher risk of disease progression.


Hoerres pointed out that the uptick in obesity has been associated with an increase in the number of patients suffering from gastroesophageal reflux disease, a condition that often leads to Barrett’s esophagus.


According to Cernostics, most current diagnostic approaches offer a limited view of cancer because they fail to evaluate the tumor as a system composed of multiple, interacting cell types, not just tumor cells. Hoerres said Cernostics’ technology is designed to evaluate tissues by a pathologist using light microscopy. The systems biology approach evaluates immune, stromal, stem cell, and tumor biomarkers on a single slide, while preserving and evaluating tissue structure.


From a single slide, the TissueCypher is designed to identify: tissue structure; specific cell types within the tissue such as immune, epitheliam, and stromal cell types; spatial relationships, including distributions and gradients of biomarker expression within tissue structures and cell types.


“Cernostics’ tissue platform automatically and simultaneously evaluates literally thousands of unique views off that tissue,” Hoerres said. “The software platform extracts a lot of information from the slide and that information could be used to better diagnose disease and predict prognosis for certain patient groups as well.”


Currently the company’s business model is to be a clinical reference laboratory so the way it would work is a physician collects a tissue sample during a biopsy and sends it to Cernostics. The company would evaluate the sample and send the physician a clinical report with the results.


While it is a platform technology with the potential for more applications, Hoerres said Cernostics is “focused like a laser” on developing its first test for the Barrett’s esophagus indication. He said the company is considering licensing opportunities to allow larger organizations to use the platform for other indications.


“Our direction for follow-up tests would probably be to develop tests specific to GI indications,” he said.


Earlier this year, Cernostics reported winning two U.S. patents and one Japanese patent related to its TissueCypher technology.


In December, the company reported that it had raised $1.4 million in Series B funding to support the development and commercialization of TissueCypher for Barrett’s. The company’s investors include Novitas Capital, Geisinger Health System, and the Pittsburgh Life Sciences Greenhouse. The company has raised more than $6 million to date from a variety of sources including grants and investment dollars.


Published  April 21, 2014