Prometheus Laboratories targets millions of individuals with undiagnosed celiac disease
Direct-to-consumer (DTC) testing for celiac disease is now a reality. One company is now marketing a saliva-based genetic test that allows a patient to request, administer, and check the results of the test without leaving his or her home!
The market for this test is substantial. According to the National Digestive Diseases Clearinghouse’s web site, more than two million people in the United States have the disease, or about one in 133 people. A significant number of these individuals are undiagnosed or misdiagnosed celiac victims, which is why a DTC test may prove to be a marketplace winner.
The test is called MyCeliacID . It was developed by Prometheus Laboratories, Inc., of San Diego, California. Testing is done by Prometheus’ CLIA laboratory, which is CAP and New York state accredited. A licensed physician will review and place the order in accordance with state and federal law after a test request is made online. There is a genetic counselor on staff who is available to discuss results with patients.
“It’s a new area for us, but so far it is working quite well,” said Kathy Davy, Associate Director of Marketing for Prometheus. “We are getting strong interest in this test. Also, using the Internet as a channel to reach patients is something new for us. We recognized that a large number of patients have difficulty getting the right tests to diagnose celiac disease. These patients can now use the Internet to learn about the test and purchase it if they want.”
Prometheus notes that the test does not tell a patient whether or not they suffer from celiac disease. Rather, it informs them whether or not they have the genes associated with celiac disease. MyCeliacID tests for risk-associated alleles at HLA DQA1 and DQB1. For people who do not have the specific celiac HLA alleles, it is highly unlikely that they will develop celiac disease. While there is no medical treatment for the disease, it can be managed by regulating gluten intake.
“Most literature suggests that the diagnosis rate of celiac in the US is about 5%,” Davey said. “That is a very low diagnosis rate and shows the potential for this test. There are a lot of people out there who don’t know they have it. They may or may not have symptoms.”
MyCiliacID sells for $329. Because it uses a saliva sample that the patient can collect, it differs from other tests for celiac disease administered by physicians that require a blood sample.
Prometheus was reluctant to release early sales numbers for the new test, but Davy indicated that the company is pleased with the results since it began marketing the test in June. Besides the obvious opportunity to better serve a large population of undiagnosed patients, Prometheus did its homework on how to sell a laboratory test via the Internet.
“We did extensive research to understand online habits of this target demographic,” explained Davy. “For example, when consumers or patients wonder if they have celiac disease, where do they go for information? Which web sites do they visit?
“We’ve learned that our media strategy must support the online presence,” she continued. “Prometheus advertises both in print and on the Web in order to reach celiac patients seeking information. We use our online presence as the place we can interact with them to educate them on celiac disease and how genetic testing can provide them with useful information.”
For pathologists and clinical laboratory managers, this represents another example of how and why genetic-based diagnostic tests will be advertised directly to the public. With many physicians underexposed to the latest medical knowledge about celiac disease, it is a good business strategy for Prometheus to make education and access to the MyCiliacID test available to consumers. It provides another marketplace example of how and why a diagnostic is marketing its proprietary test directly to consumers and patients.