The causes of autism remain mysterious, and LinusBio is entering an ongoing and heated debate over what roles a tangle of environmental and genetic factors may play.
Researchers have created a first-of-its-kind test for autism that, according to their claims, can detect risk factors in a single strand of hair. This breakthrough may enable clinicians to detect the condition in young children before they fail to meet developmental milestones.
The test is a diagnostic tool to aid clinicians in the identification of autism, but it should not be relied upon exclusively. LinusBio is still in the early stages of development and is a long way from receiving federal approval. The technology uses an algorithm to analyse hair for patterns of particular metals that researchers say are associated with autism because hair records a history of exposures to metals and other substances.
This test for autism is the first to analyse this type of exposure history over time. The analysis predicted autism accurately about 81% of the time, according to a peer-reviewed study published last month in the Journal of Clinical Medicine.
The researchers hope the technology could help children receive early intervention treatments sooner and also lead to the development of new drugs or therapy models for young children.
“The technology is incredibly novel. The use of hair and the type of measurements they’re doing with hair is innovative,” said Dr. Andrea Baccarelli, a professor of environmental health sciences at Columbia University, who was not involved in the company’s research. “It’s groundbreaking.”
The causes of autism remain mysterious, and LinusBio is entering an ongoing and heated debate over what roles a tangle of environmental and genetic factors may play.
Researchers have discovered myriad risk factors associated with autism, including infections during pregnancy, air pollution and maternal stress. Although many were excited about the potential of the underlying science, most said caution is warranted and that more research is needed.
According to Manish Arora, the company’s co-founder and CEO and professor of environmental medicine and public health at the Icahn School of Medicine at Mount Sinai, the academic division of the Mount Sinai Health System, the LinusBio test examines the history of the metabolism and tells the tale of what substances or toxins the child has been exposed to over time.
The technology was created based on Mount Sinai University’s research. Hair can provide an infant with a glimpse of developmental events such as the third trimester of pregnancy.
A laser is used in the experiment to travel the length of a hair and use its energy to transform it into plasma for analysis. According to Arora, a centimetre of hair, or less than half an inch, can record about a month’s worth of exposure data.
Hair growth enables scientists to comprehend what was occurring in a person’s body at particular points in time, similar to how a tree’s ring structure provides information about growing conditions every year. According to LinusBio, its test can reveal metal metabolism every 4-6 hours.
According to Baccarelli, “it’s almost like having a security camera where you can go back and look at four pictures a day.”
The method generates a tonne of data. a machine-learning algorithm that has been trained to look for patterns of dysregulation in metals that the researchers believe are biomarkers of autism.
One centimetre of hair is all it takes to detect the autistic rhythm, according to Arora. Arora and his team believe that by using their technology, young kids—even newborns—will be able to receive early interventions for autism sooner than they can currently.
The issue with autism is that, on average, a diagnosis is made at age 4. By then, the brain had already undergone a great deal of development, he claimed. We want to enable early intervention.
A biological test for autism spectrum disorder does not yet exist. Parents typically notice behavioural differences in their children before a diagnosis is made, such as eye contact avoidance, language delays, or a lack of pointingch as eye contact avoidance, language delays, or a lack of pointing. Autism can co-occur with other conditions like attention-deficit/hyperactivity disorder (ADHD), anxiety, and mood disorders, but these behaviours vary widely.
Early intervention for autism typically involves individualized instruction with a trusted teacher. These programs are implemented when symptoms emerge to address specific developmental needs. Little is known about what effect pre-symptomatic intervention might have for kids at higher risk of autism.
LinusBio’s test was given the “breakthrough” label by the Food and Drug Administration, which is meant to expedite the regulatory approval procedure for novel technology when there are no competitive products available. The designation does not alter the requirements for approval, and the company still needs to clear regulatory obstacles before its product can be considered for widespread use in the United States.
In the published study, researchers evaluated hair samples from 486 kids from Japan, Sweden, and the United States to train and test their technology.
The algorithm correctly identified cases in which autism spectrum disorder was diagnosed more than 96% of the time in an analysis of 97 hair samples. About a quarter of the time, it correctly identified negative cases. The group tested included 28 cases of autism, a much higher proportion than in a general population.
LinusBio has collected samples and data in a group of about 2,000 people and is working on an expanded study. The test could be most useful in groups with a higher risk of autism, such as children who have missed developmental markers or have siblings with autism. “No clinician should make a decision on if a child has autism solely based on this,” Arora says.
Repeat testing, which involves examining and contrasting numerous hair strands from a child, could potentially increase accuracy, according to researchers.
In Estes’ opinion, the biggest and most significant obstacles for parents of children seeking treatment for autism are finding qualified clinicians who can make a specialised diagnosis and assembling a care team for the child. Estes believes that neither a test nor technology can address this issue. Even if they do notice developmental delays, she said, many parents are unable to access assistance.
Most children currently do not have access to timely intervention, according to Estes. “We know how to assist children. It’s very challenging to gain access. Arora hopes that in the future, the new technology could also yield clues about what is changing in a child’s body as autism manifests. Perhaps eventually, that information could open up new pathways for the development of drugs or therapies for autism, he said.
LinusBio said it also plans to apply the approach to other health conditions with known links to environmental factors, including Lou Gehrig’s disease, or ALS, gastric disorders and certain cancers.