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Esophageal Pre-Cancer Testing Gaining Greater Traction

by Ron Shinkman | Oct 29, 2024 | Clinical Diagnostics Insider, FDA-dtet

How three companies are addressing screening challenges with tests that help improve chances of early detection

An elderly male patient holds a hand to his throat as he speaks with his doctor, illustrating the concept of throat problems and potential esophageal cancer. — iStock, PeopleImages

Although it kills a fraction of the people who succumb to lung or breast cancer, 16,000 Americans still die from esophageal cancer every year. A big contributor to these deaths is the fact that esophageal cancer is usually not detected until its advanced stages because people don’t typically get tested unless they are showing symptoms such as difficulty swallowing. This lack of early testing is among the reasons the five-year survival rate for esophageal cancer is less than 22 percent, according to data from the National Cancer Institute.¹ That compares to breast cancer’s five-year survival rate of more than 91 percent.²

Several laboratory companies are addressing this early detection challenge for esophageal cancer, positioning tests to better predict cancer risk rather than just diagnose its presence.

Unlike many other cancers where there is no clear precursor, esophageal cancer is often connected to a condition called Barrett’s esophagus. This condition occurs when acid reflux damages the surface lining the passage between the throat and stomach, causing changes in its cells. Although having the condition can increase the risk of esophageal cancer by up to 100 times, the risk of contracting such a cancer with the condition is only about 5 percent.³ However, detecting the condition can identify patients who may benefit from additional testing and surveillance, helping detect cancer earlier in those who go on to develop the disease.

Detecting Barrett’s esophagus

For example, Lucid Diagnostics is deploying its EsoGuard test—which analyzes DNA to detect Barrett’s esophagus—in ways intended to raise greater awareness for both the risk of contracting the condition and the availability of its assay. Sample collection for the test is performed by having patients swallow a small textured balloon, which collects tissue. The balloon is then retrieved by pulling it back out through the patient’s throat.⁴

The New York-based Lucid, a subsidiary of PAVMed, has organized several testing events for fire departments.

Shaun O’Neil, Lucid’s president and chief operating officer, noted that the company has held about 150 events testing firefighters through arrangements with local fire departments. Altogether, about 5,000 firefighters have been tested to date. Firefighters can be more prone to developing Barrett’s esophagus because they often inhale irritants when fighting blazes, O’Neil said.

According to data from the National Institute for Occupational Safety and Health, firefighters have a 9 percent higher risk of being diagnosed with cancer than the general population and a 14 percent higher risk of dying from cancer.⁵

An events-based test distribution strategy

“We have a very robust pipeline of events that usually book three to six months in advance,” said O’Neil, who added that the events are only “scratching the surface” in the firefighting community. The testing events are promoted through Lucid’s social media campaign #CheckYourFoodTube.

In October, Lucid Diagnostics took the public testing events further, testing a group of retired National Football League (NFL) players in Cincinnati. O’Neil observed that retired NFL players do not have a higher risk for developing esophageal cancer than the general population, but an opportunity presented itself and the company pursued it.

“The greater Lucid team has a relationship with some of the retirees and they showed interest in hosting an event for their members,” he said. Future testing events involving NFL players are in the works, the company said.⁶

EsoGuard test volumes have been solid. According to public filings, about 5,500 EsoGuard tests were performed during the first half of 2024.^7,8 The test retails for $2,499, while Medicare pays $1,938 under the Centers for Medicare & Medicaid Services’ Clinical Lab Fee Schedule.⁹ O’Neil declined to provide projections of future test volumes.

For now, the testing events involving fire departments and other employers make the most sense as a business model to distribute EsoGuard, according to O’Neil.

“We are still navigating medical policy change and…it doesn’t make sense for us to continue to scale our commercial business for standard claim submission,” he said. “Our focus currently is direct-to-employer initiatives, contracted health fairs, and concierge medicine.”

Testing patients with Barrett’s esophagus

Esopredict^TM, created by Baltimore-based Previse, takes testing one step further. Its laboratory-developed test is for patients already diagnosed with Barrett’s esophagus, predicting the five-year cancer risk in patients who have the condition. Specifically, the test determines the risks for patients developing either high-grade dysplasia or esophageal adenocarcinoma.

The company has had several studies published in recent months about the efficacy of the test. One study, published in August in the American Journal of Gastroenterology, retrospectively evaluated 240 patients who had undergone the test.^10,11 It concluded that when the assay predicts a high risk of cancer progression, these patients had an average risk of progression of 22 percent over the next five years. That’s more than quadruple the general assumptions about cancer risk in patients with Barrett’s esophagus. In contrast, patients who tested as low risk for developing cancer had a 1.9 percent average risk of progression.¹¹

The test, which has a self-pay rate of $2,750, received a Proprietary Laboratory Analyses code (0398U) from the American Medical Association last year. The test has been becoming more popular, according to Stacey Gilbert, Previse’s head of outcomes, value, and access.

“It has been exciting to see the changes in decision-making that gastroenterologists are making when utilizing Esopredict in both upstaging or downstaging endoscopic surveillance intervals and treatment decisions,” Gilbert said, although the company did not release any sales data.

Earlier, in fall 2023, the company secured a $1.8 million Direct to Phase II Small Business Innovation Research (SBIR) grant from the National Institute of Diabetes and Digestive and Kidney Diseases to commercialize its products.¹²

Detecting signs of potential cancer with AI

Another lab company that has been getting the word out on its test is Suffern, NY,-based CDx Diagnostics and its artificial intelligence-powered WATS^3D assay. In another study involving 24,000 patients that was recently published in the American Journal of Gastroenterology, the performance of the test was compared against that of traditional analysis involving biopsies obtained by forceps. WATS^3D discovered 1,317 cases of intestinal metaplasia—spreading of irregular cells into the start of the digestive tract—that traditional biopsy did not. Another 107 cases of dysplasia caused by Barrett’s esophagus were diagnosed by WATS^3D that were not caught through forceps-procured biopsies.¹³

“The landmark findings highlight how our AI imaging technology can effectively transform early detection rates and empower physicians to intervene before progression to esophageal cancer,” said CDx chief operating officer Duane Dorn in a statement.¹⁴