Pittsburgh Technical Council

Cernostics’ TissueCypher Test

Cernostics’ TissueCypher Test

Article Published: May 17, 2017


If you’re in startup mode, you know how critical it is to match your product or service with market-place demand and available funding sources. Mike Hoerres, Founder and CEO of Cernostics, headquartered in Pittsburgh, knows these factors better than most.

Mike has spent more than 25 years generating revenue and building new markets in the life sciences industry. Before heading up Cernostics, he was Principal at Geisinger Ventures, the venture arm affiliated with Geisinger Health System, a leading integrated healthcare delivery organization.

The TissueCypher® test of Cernostics, now commercially available, is the first clinical assay to combine quantitative analysis of multiple protein-based biomarkers with tissue structure information to predict the risk of progression to esophageal cancer in patients with Barrett’s esophagus. 

Barrett’s esophagus is a precancerous condition predominantly seen in patients with longstanding acid reflux disease. In patients who suffer from Barrett’s esophagus, the tissue that lines the esophagus—the food pipe that connects the mouth to the stomach—is replaced by abnormal, precancerous tissue. It’s estimated that as many as 10 million people in the United States suffer from Barrett’s esophagus, and most don’t know they have it.

The TissueCypher test aids pathologists’ interpretations of standard pinch biopsies from upper gastrointestinal endoscopy procedures. The technology uses digitally scanned images of a biopsy to measure and analyze cellular and molecular changes that precede structural changes within the tissue of the esophagus.

The results of a recent study developed by Cernostics to support the clinical use of the TissueCypher assay showed that patients with Barrett’s esophagus are 46 times more likely to have either high-grade dysplasia (HGD) or esophageal cancer at the time of biopsy vs. patients with Barrett’s esophagus who scored low risk on the TissueCypher test. 

Esophageal cancer used to be a rare form of cancer, but has become one of the fastest growing cancers in the world. In the last 30 years, the incidence of esophageal cancer has shot up by more than 500 percent, and it remains highly lethal. The 5-year survival rate is only 18 percent. 

This dramatic increase in the incidence of esophageal cancer is linked to increases in obesity and chronic gastroesophageal reflux disease (GERD) in western countries, both of which are major risk factors for the development of esophageal cancer. 

Up to now, gastroenterologists lacked a way to tell which patients with Barrett’s esophagus would likely develop esophageal cancer and which ones would not. In effect, the TissueCypher test assists their diagnoses by combining 20th-century pathology with 21st-century computational power.

“The TissueCypher assay,” said Hoerres, “provides gastroenterologists with a rule-in test that identifies patients who need more aggressive treatment and surveillance because of their higher risk for esophageal cancer, and a rule-out test that identifies which patients aren’t likely to need aggressive treatment and surveillance for esophageal cancer.” 

The test provides a risk-score range from 0-10, with 0 indicating lowest risk and 10 indicating highest risk. What’s more, the risk score is independent of clinical variables, like pathologic diagnosis. 

According to Hoerres, the company’s investors include Pittsburgh’s own Pittsburgh Life Sciences Greenhouse and UPMC Enterprises, Novitas Capital, and Geisinger Health System. The company has raised more than $11 million from these and other sources, including a recently closed Series B funding round to support development and commercialization of the TissueCypher test for Barrett’s esophagus. 

Cernostics is now evaluating additional clinical indications—including immunotherapy drug selection, and lung, colon and breast cancer— for which the TissueCypher platform can provide actionable clinical information.

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