In ancient times carefully placed stacks of stones would be created as a way of noting a specific place or as trail markers to ensure travelers marked their course and didn’t lose their way. They were called “cairns”. Kerry Bush, the President and Chief Operating Officer for Cairn Diagnostics, chose this name for his company because their diagnostic products provide gastroenterologists with markers to lead the way towards diagnosis and treatment of gastroparesis.
Bush has a deep interest in not only the science and discovery behind clinical research but also in identifying viable clinical uses that can be employed in medical practice every day.
“I worked as a director in large reference labs for 25 years,” said Bush. “Then I was offered an opportunity to do a startup using a non-radioactive substrate platform to detect disease or measure physiologic functions. I worked on that product 20 years ago, and it turned into a very viable product that is still in use today. Thousands of these tests are given every year to detect a bacteria that lives in the stomach called Helicobacter pylori, or simply H.pylori, which is associated with ulcer disease and cancers of the stomach.”
Before the creation of the H.pylori test, which involves drinking a lemonade solution that contains Carbon-13 (denoted as 13C), a rare, stable (non-radioactive) isotope of carbon, the diagnosis was much more invasive. Patients had to have their stomachs scoped and have a biopsy, then a special stain was applied to the biopsied material in hopes of identifying the bacteria.
“With that test, a breath sample is collected before you drink the lemonade, wait 15 minutes, and then a second breath sample is collected,” explained Bush. “Infection can be detected from the second breath sample.”
After his work with the H.pylori breath test, the National Institutes of Health (NIH) funded he and his team to develop a breath test to identify genetic disorders of metabolism. This test detected Galactosemia, an inherited disorder that prevents newborns from breaking down the sugar galactose from their mother’s milk. Without treatment, a baby can die from the disease in five to six days. That test was also a successful means of detecting genetic disorders.
It was his work on these two products that led him and his colleagues to develop a test to replace the nuclear medicine test most frequently used to detect gastroparesis. After selling his other products to another entity, he decided to take the gastroparesis test to the market himself. That is how Cairn Diagnostics was born.
Cairn’s Gastric Emptying Breath Test (GEBT) has revolutionized the procedure for detecting delayed emptying, and gastroparesis. The test can be administered either in a doctor’s office or via telehealth while being coached by highly qualified staff at Cairn.
“The traditional procedure for assessing a patient’s rate of gastric emptying requires a patient to go to a nuclear medicine lab, have a meal that usually consists of eggs, toast, and skim milk that contains radioactive isotopes, and then they have to sit there for two to four hours with periodic stomach scans to calculate the decline in radiation over time,” said Bush. “The rate of decline of radiation provides a means of determining the patient’s gastric emptying rate.”
Cairn has developed a non-radioactive alternative to the nuclear medicine test using non-radioactive 13C. It comes in a box that looks much like a catered lunch box. In the test box is everything a doctor or individual will need to conduct the test in a doctor’s office or clinic. Administration of the test does require a prescription.
“It’s simple to administer,” explained Tyler Hill, Director of Operations. “The content of the meal packet can be poured into a cup and heated in the microwave. Previous to eating the meal the patient provides two breath samples as a baseline, and then we collect six breath samples over four hours after the patient eats the test meal. Analysis of these samples let us calculate and report the rate at which the meal is emptying from the stomach over a four-hour period.”
Cairn develops the test, manufactures it, distributes it, analyzes the results from the test, and then provides an in-depth report to the patient’s doctor so that he or she may define a treatment program. Cairn also has a team of highly qualified clinicians and scientists on board to answer any questions that may crop up.
“It sounds like a very simple test,” said Bush, “but the underlying science is not so simple. We have put together an outstanding team of physicians and doctoral (PhD) scientists to bring the product to market.
They have completed all of the FDA approvals and the test is covered by Medicare and other insurers. The American College of Gastroenterology recommends the test for detecting gastroparesis. Feedback from clinicians and patients has already been excellent.
“What makes us unique is that instead of going to a nuclear medicine site at a major hospital in a major city,” said Bush, “you can sit quietly at home, read your kindle, work on your laptop or even watch television during the test administration period while we administer the test to you virtually. With COVID, that has been a real plus,and the telehealth option avoids long or inconvenient commutes to a large metropolitan center, especially from smaller communities and rural areas.”
