New Blood Test Shows Promise for Early ASD Diagnosis

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For years, scientists have been focusing on finding better ways to diagnose autism disorders, and are hopeful to establish a method that will diagnose children at earlier ages. In the latest attempt, researchers at Stemina Biomarker Discovery in Madison, Wisconsin, and the Mind Institute at the University of California-Davis, have conducted an early-stage blood test that identified autism in children with a high level of accuracy.

For the study, the researchers at Stemina analyzed blood samples from 82 children ranging in age from 4 to 6 years old, with 52 of the children having autism disorders, and 30 without. The team of researchers analyzed metabolites in the blood, trying to establish which molecules may signal autism. This study separates itself from previous research, as most blood-based biomarker studies have tried to distinguish any defects by examining gene expression.

Stemina has also conducted a study in partnership with UC-Davis involving nearly 300 patients, as well as a 210-patient study in conjunction with the Arkansas Children’s Hospital Research Institute. However, the results of these studies have yet to be published, as the test is “still at least three years and one larger-scale study away from commercialization”, according to Elizabeth Donley, co-founder and CEO of Stemina.

Stemina uses metabolomics technology to perform toxicity tests on compounds for drug developers and consumer products. A blood test for autism would be the company’s first diagnostic product. Diagnosing the disorder as early as possible is critical, as studies have shown that early treatment is incredibly beneficial to the child, building their cognitive and social skills. The primary challenge in creating an earlier diagnosis for autism is that the standard diagnosis is based on a series of behavioral testing, as opposed to a biological test.

Donley states that her company’s test is going to be advantageous, as it studies the metabolites instead of gene expression, providing a “readout of the organism’s current state in real time.” She continues, “Gene expression will also be important, but we don’t believe it will be as predictive.” Although Stemina’s test does not provide answers to the process of how a child becomes autistic, it can provide strong evidence of what is different about that child, leading to an earlier diagnosis. She states, “That’s where we think the promise is of this particular test and approach.”

The test results demonstrate the differences in the metabolism of children with ASD, which distinguishes them from neurotypical children. Stemina was able to distinguish autism through their blood test with 81 percent accuracy, with their subsequent studies showing equal levels of accuracy. “We are very pleased with the result of this first study because it demonstrates that differences in the metabolism of children with ASD are profound enough to distinguish them from typically developing children,” Donley states. She continues, “This will allow us to understand the individual metabolism of children with ASD in a way we never could before, leading to earlier diagnosis and individualized treatment.” Stemina now plans to conduct its own clinical study involving over 1,500 children, and has a target date of late 2017 to launch their blood test.

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