New study support for Metabolon
Recent study results reinforce the clinical validity of the company’s IGT test
RESEARCH TRIANGLE PARK, N.C.—Results from a study of Metabolon’s Quantose IGT test recently appeared in the Journal of Diabetes Science and Technology, supporting the clinical validity of the test for assessing impaired glucose tolerance (IGT), a state of prediabetes. Quantose IGT is a laboratory-developed test that reflects the degree of impaired glucose tolerance, a core metabolic defect in dysglycemia and a known risk factor for developing diabetes and cardiovascular disease.
“This study verified that the Quantose IGT test accurately reflects IGT, which may provide the opportunity for earlier clinical intervention that could help curb the epidemic of type 2 diabetes,” Eric Button, senior vice president of diagnostics at Metabolon, noted in a press release. “We look forward to bringing this new test to the market in the coming months.”
The test is designed to enable physicians to easily identify IGT using a single, fasted blood draw, a simpler, less unpleasant approach than the oral glucose tolerance test (OGTT), the current clinical practice standard for measuring IGT. The OGTT is a somewhat involved process, requiring patients to fast prior to the test, undergo a blood draw to determine a fasting glucose level and then drink a glucose-rich beverage and undergo multiple blood draws over the course of roughly two hours.
Button explains that the OGTT currently stands as the standard for checking the blood glucose levels of pregnant women, specifically if a glucose screening test result is higher than normal and there is a concern about gestational diabetes. However, while there are approximately three million births in the United States each year, he says, fewer than a million tests are performed for OGTT due to its inconvenience.
“From the patients’ perspective, it goes beyond just a level of inconvenience,” adds Doreen Bates, senior director of marketing at Metabolon. “Many people who’ve had to take this test end up with nausea, upset stomach, that kind of thing, because they go in fasted, and then they take blood draws. They do the test, you have to sit in the doctor’s office for those two or three hours, so there’s a physical and an inconvenient element to it as well.”
Button tells DDNews that while OGTT is also the current standard when it comes to diagnosing diabetes, that is another instance in which physicians pass over the test given how time-intensive and taxing it is.
“If one had a simple blood test that could replace OGTT, it would be used frequently as the convenient, gold-standard diabetes test,” he notes.
Using its metabolomic profiling technology, Metabolon identified several metabolites whose fasting levels are associated with both dysglycemia and type 2 diabetes, which form the basis of its Quantose IGT test. The test was developed using fasting plasma samples taken just prior to an OGTT from 1,623 non-diabetic subjects from two different cohorts: 955 from the Relationship between Insulin Sensitivity and Cardiovascular Disease Study (RISC Study; 11.7 percent IGT) and 668 subjects from the Diabetes Mellitus and Vascular Health Initiative cohort from the DEXLIFE project (11.8 percent IGT).
Button says that the Quantose IGT test offers a more accurate approach, because the sugar solution that has to be drunk with the OGTT “adds a lot of unknown variables,” an issue Bates echoes.
“We’re measuring what’s going on within a person’s body as it’s actually occurring, without, as Eric said, that artificial adjustment from the sugar drink that you have to take when you do the oral glucose tolerance test; that’s artificially adjusting your body to stress it in some ways, and we’re not doing that. We’re just measuring what’s happening in your body as it’s occurring currently,” she explains.
As the company advances the Quantose IGT test, Button says they will be conducting additional studies to support its clinical utility, in addition to seeking reference laboratory partners to aid in the nationwide distribution of the test. In the third quarter of 2014, Metabolon announced a partnership with Metadia Biotech S.L. to commercialize its Quantose IR and Quantose IGT prediabetes tests in Europe (for more information, check out “Metabolon taps Metdia for European marketing of prediabetes test” in the Diagnostics section of our November 2014 issue).