StrandDx™ ASD Test
Autism Spectrum Disorder Diagnostic Aid
LinusBio is developing a biochemical lab test for autism. We anticipate that doctors will use our test, StrandDx™ASD, as a diagnostic aid in the context of a patient’s medical history and screening for autism.
Autism experts emphasize that it is important to accurately detect and diagnose children with autism as early as possible. Children build the foundation for language and social functions during a critical period of brain plasticity in the first two years of life. Currently, the median age for diagnosis of autism in the United States is four years and two months. Earlier detection of autism could help caregivers connect with health care providers and determine which services, educational programs, and behavioral therapies are most likely to be helpful for their child.
Autism is diagnosed based on an expert’s observation of symptoms in children 18 months and older. The DSM-5 criteria for diagnosis are:
Unlike other conditions, such as diabetes or hypertension, where A1C or diastolic blood pressure readings serve as biomarkers to confirm the diagnosis, no objective measurement for autism has been available.
StrandDx™ASD provides a result, calibrated to the DSM-5 diagnostic criteria, to aid clinicians in diagnosing autism and ruling out autism, sometimes even before its symptoms become pronounced.
When StrandDx™ASD becomes available, LinusBio will provide information to doctors about its appropriate use as a diagnostic aid. It will be possible to test infants as young as age one month if their hair is at least one centimeter long. When a child’s doctor orders StrandDx™ASD, we will send the child’s family a package with instructions for returning a few strands of the child’s hair to our laboratory. The child’s doctor will receive the results and discuss them with the family.
How Does StrandDx™ASD Work?
StrandDx™ASD builds upon years of prior research showing that metals and essential elements from diet and the environment play a role in autism. We have discovered that the timing of exposures is relevant to the development of autism, particularly past and concurrent exposures, and internal factors such as the individual’s age, sex, and genetics.
An individual’s metabolism--the chemical reactions taking place in their cells to extract energy, create biomolecules, and eliminate toxins—plays a key role. As early as birth, the dynamics in metabolism of more than a dozen metals and other elements are systemically dysregulated in individuals with autism.
StrandDx™ASD incorporates temporal exposomic sequencing, an innovative approach to measuring the effect of the exposome on health. In our laboratory, we analyze a strand of hair using laser-based mass spectrometry techniques to characterize an individual’s unique biological response to their life history of environmental exposures up to the present. StrandDx™ASD assesses the pharmacokinetics and the pharmacodynamics of multiple elements retrospectively. Pharmacokinetics describes how a person’s physiology acts on these molecules. Pharmacodynamics describes how these molecules act on the person’s physiology.
For autism, the result is a data set with 15 columns—one for each element relevant for autism--and more than 500 rows—one for each time point captured. The data set is expanded to include almost 10,000 features of the dynamic patterns of the 15 molecular signatures: how they change independently and in relation to each other, how long they are stationary, what periodicity they exhibit, and so on. StrandDx™ASD leverages the patterns uncovered in these data to predict autism using advanced computational methods.