Breakthrough autism test that detects risk in babies using a single strand of hair is approved in US

Scientists have announced a first-of-its-kind diagnostic test for autism spectrum disorder (ASD) that only requires a single strand of hair.

LinusBio, based in New Jersey, launched its Clearstrand-ASD Thursday to help physicians rule out the condition in children between one and 36 months of age when autism is a concern. It does not provide a diagnosis. 

‘The test is intended for infants and toddlers who are at an elevated risk of autism, such as those who were born preterm, who have a sibling with autism, or who have demonstrated characteristics associated with autism,’ researchers said.

While Clearstrand-ASD only rules out autism, doctors currently rely on observational signs that leave parents waiting for answers. The average age for an autism diagnosis in the US is four, but some children show signs at birth.

The system analyzes the strand of hair with lasers, turning it into a plasma to be processed by machine-learning algorithms. 

The technology then captures the child’s metabolic history, which includes substances or toxins they have been exposed to or their body has processed.

Research has linked metals like mercury, lead, cadmium and arsenic to the root of the disorder, which Manish Arora, a co-founder of LinusBio and its CEO, said is part of his company’s analysis.

LinusBio said the ClearStrand-ASD is 92.5 percent accurate and results are given in about three weeks.

ClearStrand-ASD testing is now available in 44 states, except California, Maryland, New York, Rhode Island and Pennsylvania, for the cost of $2,750.

The tests can be ordered through LinusBio or set up with a primary care doctor with the system at their practice. However, costs are not covered by insurance.

According to the latest CDC data, one in 36 children in the US have autism. This is just under two million.

Thomas Frazier, PhD, Professor of Psychology at John Carroll University, said parents are forced to wait too long for answers due to the average age of a possible diagnosis. 

‘This is challenging, as early intervention—particularly between one and three years—has been shown to improve language and social communication skills significantly,’ he added.

The ClearStrand-ASD collects thousands of data points from the strand of hair fed to an AI to identify an autism biomarker, NBC reported.

‘This biomarker is a set of molecular patterns that indicate a child’s biological response to certain essential and non-essential elements,’ LinusBio’s website states.

‘In other words, the way in which these elements are metabolized is different between autistic and non-autistic individuals.’

Families will receive one of two results: Negative or Non-negative.

Negative means there is a 92.5% probability that the child will receive a diagnosis of autism if evaluated, while the latter means the disorder cannot be ruled out.

Arora published a study in 2017 that looked at a set of twins, one of whom had autism.

By analyzing the growth layers of baby teeth, he and his team measured how much of certain metals (both essential and toxic) the twins were exposed to before and after birth.

They found that the twin with the disorder had lower levels of essential minerals like manganese and zinc, which are important for brain development, but higher levels of lead.

These differences were only noticeable during specific stages of early development.

Other studies have also shown growing pollution and chemical contamination in food and water may allow toxins to infiltrate the bloodstream of pregnant mothers and travel to the brain of the developing fetus, causing inflammation that impairs nerve signals and leads to autism.

Additionally, more babies are surviving being born prematurely than in decades past, making them more vulnerable to developmental delays and autism.

This could be related to the fact women are having children older than ever or other changes to do with parents, such as the rising prevalence of obesity.

‘The focus is really on early intervention,’ Arora told NBC News. ‘The earlier you intervene, the better off children are.’

He conducted another study with a group of 490 children in California with elevated risk of autism spectrum disorder and found the system was 92.5 percent accurate.

However, those results have not been published in a peer-reviewed journal.

Outside experts said LinusBio’s ClearStrand-ASD could eventually be the way to identify autism risk, but suggested it needs more research.

Stephen Sheinkopf, a professor of pediatrics at the University of Missouri School of Medicine, told NBC: ‘To me this feels like it’s on the earlier side of things, not the earliest. They have some compelling results.

‘This seems like an approach that has the potential to be part of a suite of ways we can screen children for concerns, but it’s, to me, at the stage of needing more evidence.’

He suggested that families concerned about their children having autism should speak to their pediatricians or primary care physicians who will closely monitor them and screen them as the years go by.