Although, the Diagnostic Hair Strand Test Is Still Far from Federal Approval
In January of 2022, SafeMinds Shares reported that an exciting new autism diagnostic test from LinusBio had received a “Breakthrough Device Designation” from the Food and Drug Administration (FDA). LinusBio developed the test to identify autism risk markers from a single strand of hair. A new peer-reviewed study has discovered that their test accurately predicted autism 81% of the time in children from three different countries (Japan, Sweden, and the United States). Specifically, this test analyzes the history of a child’s metabolism, showing evidence of which substances, toxins, or metals (e.g., mercury, lead, and aluminum) the child had exposure to over time. Hair is an excellent vehicle for cataloging exposures to metals and other substances. The test works by running a laser along the length of a hair, which then uses the laser’s energy to turn the hair into a plasma for analysis. Only a centimeter of hair is required for the test, which captures approximately a month’s exposure data. This technique creates a large amount of data; making machine learning algorithms are necessary to analyze the data. These algorithms identify patterns of metal dysregulation in the body that some researchers believe are biomarkers of autism. An intriguing aspect of LinusBio’s test is that it can be used with infants, providing a glimpse of exposures in critical developmental periods, like the third trimester of pregnancy. The test is still in the early stages of development and has not received federal approval. Currently, it is only recognized as a diagnostic aid meant to assist clinicians in identifying autism and should not be relied on alone. LinusBio hopes its technology can help young children, even newborns, receive early diagnoses for autism. LinusBio’s co-founder and CEO, Manish Arora, who is also a professor of environmental medicine, believes this new product can change access to early treatment. He states, “The problem with autism is it’s diagnosed at the age of 4 on average. By that time, so much brain development has already happened. We want to enable early intervention.”
