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“The gold-standard validation of any new medical diagnostic is using the instrument to assess human patients,” says Sandia researcher Amy Herr. A recent study, published in the March 27 issue of the Proceedings of the National Academy of Sciences, reports on analysis of a pilot patient population using a clinical diagnostic instrument recently developed at Sandia.
The results of the Sandia measurements were then compared to accepted clinical measurements for that same group of human patients.
“We achieved faster and more reproducible results because we combined steps that ordinarily require time-consuming manual handling by many people, into a single automated device,” she says.
Because the amount of sample fluid needed for testing is so small, Herr sees further applications in other disease areas — including potentially improved diagnosis of prostate and breast cancer — as well as rapid measurements of serum in animal models employed in vaccine development research.
“This technology also has great promise for Sandia’s efforts in homeland defense,” says Sandia researcher Anup Singh. “We have efforts to use the diagnostic platform to detect biotoxins and other markers in bodily fluids to be able to diagnose exposure to a biological agent.”
Sandia has filed patents and technical advances to protect the work, Herr says. “The study has sparked commercial and university interest in our inventions. Our team — an interdisciplinary group of internal and external collaborators — believes Sandia’s contributions in this area could advance personalized medicine. So we’re motivated to extend the limits of Sandia’s lab-on- a-chip tools.”
“Lab-on-a-chip” refers to an entire laboratory on an area the size of a computer chip, requiring only tiny amounts of material to perform automated chemical analyses.
While components of the saliva-detection technique were reported earlier by Sandia, this is the first comprehensive study of Sandia’s integrated clinical method.
“Biomedical researchers have suspected that changes in the amount or type of proteins present may be useful as biological markers in disease diagnosis,” says Herr. “Our current work with a particular enzyme in saliva supports that hypothesis regarding periodontal disease.”
Aiding dental practitioners, the pocket-sized device measures the state of biomarkers to determine how much the disease has been set back. Its progress may be cloaked, silently advancing or retreating without showing any signs.