A vitamin-sized pill could be the future of esophageal cancer prevention.
Cancer of the esophagus — the muscular tube that moves food from the mouth into the stomach — has just a 20% five-year survival rate. Yet there are no standard or routine screening tests for the disease, according to the National Cancer Institute (NCI).
Lucid Diagnostics, a New York-based biotech company, is looking to change that with its newly developed test, which only requires taking a single, vitamin-sized pill.
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Fox News Digital spoke with Lishan Aklog, M.D., chairman and CEO of Lucid, about how the test, called the EsoGuard, could offer a new line of defense against a cancer that has flown "under the radar" in terms of screening.
"For the more common breast, cancer and lung cancers, early detection programs like mammography, colonoscopy and PAP testing have decreased the mortality rates by about 50% over the last couple of decades — so we know early detection works," he said. "But there are other cancers that we don't talk about as frequently, but are extremely deadly."
The three deadliest are all cancers of the gastrointestinal system, Aklog noted — pancreatic, esophageal and liver.
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"All three of them are effectively a death sentence, and we don't think about these as much."
With the new technology behind EsoGuard, Aklog hopes to offer a new routine screening for esophageal cancer and prevent deaths.
With other types of cancers, such as colon and breast, detecting the disease early in the first stage is a "victory," Aklog said, because it comes with about a 90% cure rate.
"But it's not really a victory to pick up stage one esophageal cancer," he said.
"The mortality rate for even stage one esophageal cancer is awful. It's one of the cancers that you have to pick up in the precancerous stage in order to do the appropriate interventions and surveillance, so you actually can prevent cancer."
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EsoGuard is designed to detect GERD — gastroesophageal reflux disease — which is known to be a risk factor for the development of esophageal cancer.
"There is a direct link that's not very widely known between chronic reflux, chronic heartburn and cancer," Aklog said.
"When you have fluid in the stomach, acid makes its way into the lower esophagus, where it doesn't belong," he went on. "That causes cellular changes that can eventually evolve into full-blown cancer."
Although anyone can benefit from the test, Aklog said, it is most important for people who have at least three of the six main risk factors.
Those at the highest risk include people with chronic heartburn, obesity, family history and a history of smoking.
Those who are male, White and 50 years or older are also more likely to develop this type of cancer.
Last year, Lucid partnered with the San Antonio Fire Department to screen firefighters, who have a 62% higher risk of developing esophageal cancer.
"In two weekends, we tested more than 400 firefighters, and we identified precancerous conditions in a number of them," Aklog said.
Deputy Fire Chief Darin Wallentine of the Sarasota County Fire Department said he looks forward to starting regular screenings.
"Any additional cancer screening is a tremendous benefit to the fire service," he told Fox News Digital. "Catching a pre-cancer or early-stage cancer is an opportunity for a firefighter to maintain their career and … live a long and healthy life following a career of public service."
He added, "It's all about catching cancer early and not finding it when it's too late."
Simply treating heartburn symptoms won’t help reduce the risk, Aklog noted.
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"We have pretty good medications that treat the symptoms of heartburn — but they don’t treat the mechanical problem of the sloshing of fluid into the lower esophagus, even though the pain is not there."
"Even if symptoms are well-controlled or even eliminated with these over-the-counter medications, behind the scenes the abnormalities in the esophagus are continuing and can progress to cancer," he warned.
Only about 5% of the highest-risk population are currently getting tested, Aklog noted.
"It’s a huge opportunity to have a big impact on cancer deaths."
The precancerous condition occurs in a small two-inch patch in the lowest part of the esophagus, or the food tube just above the juncture with the stomach, Aklog said.
The goal is to collect cells from that area and then perform molecular diagnostic testing that can identify genetic changes very early.
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"It’s really groundbreaking science that allows scientists to pick up these very subtle changes in the earliest precancerous stage, before the abnormalities and mutations that typically come with cancer," Aklog said.
The test has an 85% sensitivity and a 99% predictive value, he told Fox News Digital.
Historically, the only way to gather the cells was to do an endoscopy, an invasive test that requires anesthesia and sedation.
"With EsoGuard, we can collect these cells in an office setting in less than two minutes, typically without anesthesia or any kind of sedation," Aklog said.
"You just swallow this little capsule that's attached to a little, floppy catheter — a balloon-like device — and within two minutes, the cells are collected in a very targeted way."
The sample is sent to the central laboratory for analysis, after which the patient gets a positive or negative result.
"If it’s negative, they can feel comfortable that they don’t have the precancer, but if the underlying reflux continues, recent data would suggest that they undergo repeat testing every four to five years," said Aklog.
If it's a positive result, that means the patient has some degree of a precancerous condition.
"If it’s early precancer, they must undergo close monitoring with a follow-up endoscopy every three years to pick up the progression to late precancer, which is treated to prevent progression to cancer," Aklog said.
If it's a later-stage precancer, the patient would get treatment via endoscopy to eliminate the abnormal cells and prevent them from developing into cancer, he said.
Dr. Bruce Greenwald, a leading gastroenterologist at the Greenebaum Comprehensive Cancer Center at University of Maryland Medical Center, was not involved in the EsoGuard development but commented on its effectiveness.
"Esoguard detects a precancerous condition called Barrett’s esophagus, which is a known risk factor for esophageal cancer," he told Fox News Digital.
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"If Barrett’s esophagus is found, then that individual can be followed with endoscopy, and interventions can be taken before Barrett’s esophagus becomes cancerous."
Greenwald noted that while many people have GERD, esophageal cancer is relatively uncommon.
"Currently, those with GERD and the highest risk of esophageal cancer are White obese men," he said. "Other groups also carry risk, but to a lesser degree."
"A minimally invasive test like Esoguard could identify those at risk for esophageal cancer before it appears."
Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center and a Fox News medical contributor, was not involved in Lucid’s test development but commented on its potential.
"It is an office procedure that takes five minutes and has over 90% accuracy," he told Fox News Digital.
"You simply lower a pill into the stomach and pull it back out."
"It is very useful as an intermediate step for those with chronic reflux, who could have a change in the esophagus that is a precursor of esophageal cancer," he went on.
"This is especially important as we get older and the risks increase."
Siegel noted that some people are afraid of getting an "invasive" endoscopy.
"This test is an intermediate, highly accurate step to help in assessing the risk and deciding whether you need an endoscopy or not," the doctor said.
EsoGuard is now available in many major states, Aklog said.
"We’ve already done tens of thousands of tests, and physicians are embracing and adopting it for their patients," he noted. "We have numerous examples of patients in whom we've picked up the latest stage of precancer, so we’re making an impact."
The final steps in the process will involve getting insurance coverage, which is currently in the works.
The EsoGuard has proven to be a "safe and simple" test, Aklog said.
"There have been tens of thousands of tests performed with no complications," he said. "It's just basically a swab of the lower part of the food tube."
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The only caveat is that there have been a small number of false negatives and false positives, he pointed out.
Greenwald agreed that the risk of a complication from EsoGuard seems to be low.
"The test does require swallowing a catheter, which can be uncomfortable," he said.
"Identifying Barrett’s esophagus could cause anxiety about getting cancer, but most people with the condition never develop cancer," he said.
While there have been some previous efforts to develop esophageal cancer screening methods, Aklog said they have not been as "gentle" or accurate as EsoGuard.
"This is the first one that's been successful and accurate enough to play a role in a widespread early detection program."
