Developers seeking FDA Approval for microchip-based nanotechnology type-1 diabetes test, which has been performed on people with accurate results
New nanotechnology has made it possible for a team at Stanford University School of Medicine to develop a medical laboratory test for type-1 diabetes that can be performed in a physician’s office and does not require a specimen collected by venipuncture.
This microchip requires just minutes to diagnose type-1 diabetes in near-patient settings, according to a Stanford University news release.
Seeking FDA Clearance for New Diabetes Assay
This test, which also distinguishes between the two types of diabetes, performed accurately in humans. Based on these findings, developers are now seeking Food and Drug Administration clearance (FDA) for this test method. They are also considering establishing a company to bring this diagnostic technology to the clinical lab marketplace.
The researchers see an opportunity to launch this microchip in the U.S. healthcare market, which is experiencing a rapid increase in childhood obesity. This lab-on-a-chip device has an estimated production cost of just $20 and can perform 15 diabetes tests. It could also be used to diagnose diabetes in developing countries, where other types of medical laboratory tests may be cost-prohibitive or just too difficult to do.
For clinical laboratory administrators, this novel hand-held diabetes test device may one day lead to a reduction in specimens processed in central laboratories. There is also the potential to use the device in near-patient settings, which would create opportunities for pathologists and lab professionals to partner more closely with endocrinologists to improve the diagnosis and treatment of diabetic patients.
Stanford Researchers Call Attention to Need for Speed-Drive Research
The Stanford researchers called attention to the importance of rapid diagnosis of type-1 diabetes in their paper, published in Nature Medicine. “Delayed diagnosis of type-1 diabetes can result in severe illness or death, and rapid diagnosis of type-1 diabetes is critical for efficacy of emerging therapies,” wrote Brian Feldman, M.D., who was the study’s lead author. He is an Assistant Professor of Pediatric Endocrinology at Stanford School of Medicine, and one of the inventors of the microchip-based test.
25% of Diabetic Children are Diagnosed with Adult, Type-2 Diabetes
Type-1 diabetes is an autoimmune disease that usually affects children. By comparison, type-2 diabetes has traditionally affected adults and results from insulin resistance and beta cell dysfunction.
But researchers say that this is not necessarily the case anymore. Because of the increased incidence of childhood obesity, about 25% of newly diagnosed childhood diabetes cases involve type-2 diabetes. At that same, and for unknown reasons, a growing number of newly diagnosed adults have type-1, pointed out the Stanford University news release.
About 17%—or 12.7 million—children and adolescents, ages two to 19, are obese. This is triple the rate from just one generation ago, according to the Centers for Disease Control.
Incidence of Childhood Type-2 Diabetes is 50% or More in Some U.S. Regions
“In California, considered a healthier region of the U.S., 25% of the pediatric diabetes population has type-2 diabetes, Feldman told Medical News. “There are also regions of the U.S., as well as other regions of the globe, where that number actually hits or exceeds 50%. There’s no doubt that the crossover has occurred, and type-2 diabetes is no longer a disease that people only get as adults,” he continued.
According to the Stanford statement, the microchip uses no radioactivity and reportedly requires minimal training as compared to conventional tests, which use radioactive materials and produce results days after being done by skilled lab professionals.
Here’s how Stanford researchers describe their technology:
- The chip relies on a fluorescence-based method for detecting antibodies in the blood.
- Glass plates, forming the base of each microchip, are coated with an array of nanoparticle-sized islands of gold.
- The nanoparticles intensify the fluorescent response, which helps doctors identify antibodies faster.
- The auto-antibodies are present in people with type-1, but not type-2 diabetes.
“One of the key features (of the test) is plasmonic resonance, which we use to amplify the signal of the autoantibodies,” stated Feldman in the Medical News story. “The plasmonics are also so powerful at amplifying the signal that we can measure the autoantibodies using just one drop of blood. This is quite a contrast to the milliliters of blood required for RIA (radioimmunassay),” he noted.
Research May Offer Clues to Understanding and Predicting Diabetes
Researchers say the test can foresee development of diabetes and how new therapies impact the body.
“The auto-antibodies truly are a crystal ball. Even if you don’t have diabetes yet, if you have one auto-antibody linked to diabetes in your blood, you are at significant risk. With multiple auto-antibodies, its more than 90% risk,” Feldman said in the Stanford University press release.
Early clinical studies with this test encouraged the Stanford researchers to file for a patent on their microchip technology and state their intent to seek FDA clearance to offer this diagnostic test for clinical purposes. Should subsequent clinical studies validate the accuracy and quality of this lab-on-a-chip device, then healthcare may have another tool to use to achieve earlier and more accurate detection of type-1 diabetes. If so, this would be a home run for a medical laboratory test, given the incidence of diabetes and the tens of millions of people who are at risk for developing it.
—By Donna Marie Pocius