By Amy Ratner, Medical and Science News Analyst
An at-home test for celiac disease can now also be used by patients to monitor how well they are doing on the gluten-free diet after diagnosis.
Microdrop Health, a Houston-based company today began offering its imaware™ celiac disease test to patients for monitoring, through use of anti-tissue transglutaminase (tTG) and deaminated gliadin peptide (DGP) blood test results. The imaware™ test was launched in December to provide patients with blood test results they can take to their doctor as part of the diagnostic process.
Patients who have symptoms and risk factors for celiac disease often report that their doctors still don’t want to test them, and studies have shown that patients often go years without a diagnosis. The imaware™ test was designed to give patients the evidence they need to convince their physicians that testing is warranted.
In the United States, celiac disease cannot be diagnosed through blood tests alone. A biopsy that shows damaged to the absorbing line of the intestine is also needed, and imaware™ advises patients to take results to their physicians.
Following diagnosis, blood tests that measure tTG antibodies to gluten are used by physicians to determine how well someone is adhering to the gluten-free diet. Although the tTG test was developed for diagnosis and not for monitoring, it’s often used for follow-up because no other blood test is currently available. Some studies suggest that the combination of tTG and DGP biomarkers increases the effectiveness of monitoring.
The imaware™ test measures these same antibodies and gives patients quantitative results, which they can share with their doctor and a registered dietitian, said Jani Tuomi, imaware™ co-founder and spokesman.
The company now offers a subscription service that would provide an initial monitoring kit to establish a baseline of tTG and DGP results shortly after diagnosis and the start of the gluten-free diet.
A second kit would follow after 75 days, when a newly diagnosed patient should see a 50 percent drop in blood test results if they are following a truly gluten-free diet, Tuomi said. Patients being monitored by a physician might not get any follow-up testing until six months after diagnosis, he noted.
By monitoring the diet with imaware™, a patient does not have to wait that long to see if the gluten-free diet is beginning to work, Tuomi said. “Lifestyle adjustments are hard and hardest at first,” he explained. “Getting feedback earlier helps patients validate their lifestyle and diet changes or get feedback from the doctor sooner.”
Patients have the option of gettng additional kits at two, four or six month intervals. When two or more tests are purchased, each costs $89. The tests are available online only.
Patients previously diagnosed with celiac disease who have been following the gluten-free diet can also use a monitoring test to see if inadvertent gluten exposure is triggering antibody response. If gluten is not getting into the diet, blood test results should be negative.
Both newly- and previously-diagnosed patients who use the test for monitoring would collect a small sample of blood in a microcontainer, then send the sample to Microdrop’s CLIA-certified laboratory. Results are then accessed through a password protected online portal, the same way diagnostic blood test results are shared.
The report tells patients whether their results are normal or elevated for the time frame in which they’ve been on the gluten-free diet when the test is done. “It can take 15 to 18 months to come down to below-cutoff levels,” Tuomi said. “We will help you know if you’re on track or not.” In cases where antibody levels remain above normal, the report encourages patients to meet with a registered dietitian.
But monitoring of celiac disease through blood tests is tricky even for physicians. Benjamin Lebwohl, M.D., director of clinical research at the Celiac Disease Center at Columbia University, who is not connected to Microdrop, said it takes about a year on the gluten-free diet before a patient will have negative antibody levels.
“In theory, a blood check could detect ongoing recent gluten exposure, but even in the blood tests we currently use for monitoring, the accuracy for gluten exposure is far from perfect,” he said. “Also, monitoring of celiac disease after diagnosis should not be done without a health care provider, so I am not sure of its utility in that context.”
American College of Gastroenterology guidelines for celiac disease management, developed in 2013, call for annual follow-up with a physician and dietitian, which should include antibody blood tests and tests that measure vitamins, minerals and more. A bone mineral density scan one year after diagnosis is also recommended for adults.
But follow-up care is often neglected in celiac disease management. More than one out of four celiac disease patients diagnosed at least five years ago have not had follow-up healthcare for the condition in the past five years, a study by Beyond Celiac and other researchers found.
Courtney Schuchman, R.D., of the University of Chicago Medicine, has joined Microdrop as medical advisor to help the company address the needs of patients after diagnosis and while they are monitoring their celiac disease. She is tasked with helping communicate the importance of the diet and following-up with a doctor after getting tests results. She joins Detleff Schuppan, M.D., director of the Institute of Translational Immunology and Celiac and Small Intestinal Diseases at the University of Mainz in Germany and Stephano Guandalini, M.D., founder of the University of Chicago Celiac Disease Center, who are also Microdrop medical advisors on celiac disease.
Other tests to monitor gluten exposure
In 2017, Glutenostics launched at-home stool and urine tests that are also designed to tell patients if they have consumed gluten. The Gluten Detective tests detect fragments of the immunogenic gluten protein, called GIP, harmful to those who have celiac disease. Like imaware™, Gluten Detective is not approved by the FDA and cannot make a medical claim related to the treatment of celiac disease or any other condition. The tests can only claim to detect gluten consumed, fragments of which are found in the stool or urine of everyone, but only trigger an autoimmune response in those who have celiac disease.
In addition to adding celiac disease monitoring, imaware™ is decreasing the price of its diagnostic test from $165 to $99. Tuomi said the price drop was motivated in part by Microdrop’s commitment to cutting the rate of undiagnosed celiac disease. Less than 20 percent of those who have celiac disease have been diagnosed, according to most estimates.
“We want to make a dent in the number of undiagnosed cases,” Tuomi said. “Let’s get 100,000 people screened. We want to make our test so cost effective there is no reason not to get screened. Price should not be in the way of diagnosis.” At the new price point, imaware™ would cost less than other patient-initiated tests, including Let’s Get Checked, with a U.S. price of $119.
“How you drive diagnosis is through volume,” Tuomi noted, adding that in order to get new treatments and a cure for celiac disease more have patients have to be diagnosed.
Beyond Celiac is partnering with imaware™ to support the goal of dramatically reducing the number of individuals dealing with undiagnosed celiac disease by helping them more quickly take the steps needed for diagnosis. The company will contribute a portion of sales to Beyond Celiac to support ongoing initiatives to drive diagnosis, advance research and accelerate the discovery of new treatment and a cure.
Microdrop is also a corporate sponsor of the Society for the Study of Celiac Disease (SSCD) and will work with the group to promote the use and awareness of scientifically validated approaches and methods for celiac disease diagnosis, according to the SSCD website. The SSCD is an organization of medical, scientific and allied health professionals in the field of celiac disease.
Microdrop also plans to introduce an imaware™ diagnostic test for a second disease, rheumatoid arthritis in February. The condition is similar to celiac disease because it is an autoimmune disease, with a low rate of diagnosis and a high risk for first degree family members. And, Tuomi said, it’s like celiac disease because early diagnosis can reduce the negative impact of the condition.