Spectrum News
Quote:
The U.S. Food and Drug Administration (FDA) has granted ‘breakthrough device’ designation to a hair-based test designed to aid autism diagnosis. The acknowledgment shifts the test into a fast lane through the agency’s regulatory review process.
The test, called StrandDx, analyzes the levels of chemicals in a strand of a child’s hair to capture a snapshot of her ‘exposome’ — some of her cumulative environmental exposures and how she regulates certain essential nutrients. The measures suggest how a person’s physiology responds to her environment, which can predict her chances of having autism, says Manish Arora, Edith J. Baerwald Professor and vice chairman of environmental medicine and public health at the Icahn School of Medicine at Mount Sinai in New York City and co-founder of New York-based Linus Biotechnology, which is developing the test.
Previous research from the test’s makers suggested that autistic people’s teeth contain atypical levels of some metals, and that that information can be used to predict autism diagnoses.
With further development, StrandDx could also help identify subtypes of autism and predict prognoses and who might benefit from which therapies, Arora says.
Other experts say it is difficult to evaluate the technology without knowing more about what markers it analyzes and how it compares with current gold-standard diagnostic methods. Arora says his team has submitted a paper for review that outlines how the analysis works, but he declined to share it with Spectrum, citing the journal’s embargo policies.
Analyzing hair samples makes it possible to look at chemical exposures and how the body regulates them over time, Arora says, similar to how the rings of a tree can reveal its age and changing environment.
To use StrandDx, a clinician would request a kit to collect a hair sample from a child and return it to the company. The technology is intended to help predict the likelihood that a child has autism from birth to 18 months of age and assist in diagnosis from 18 months to 21 years.
But it is unclear how hair could provide information about exposures that occurred prenatally, when autism is thought to develop, Miller says. The first centimeter or so of hair growing from a follicle generally reflects only the past 30 days of someone’s exposures, though it’s feasible signatures extending beyond the hair’s lifespan could be detected with more development, he says.
Developing predictive biomarkers such as StrandDx is particularly difficult given the “shifting diagnostic boundaries” of autism, Sheinkopf says. Different markers may emerge depending on who is considered for inclusion in a study, for example.
“The field is still grappling with how broadly we should define autism,” he says. “That creates a major challenge for developing tests like this.”
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Professionally Identified and joined WP August 26, 2013
DSM 5: Autism Spectrum Disorder, DSM IV: Aspergers Moderate Severity
It is Autism Acceptance Month
“My autism is not a superpower. It also isn’t some kind of god-forsaken, endless fountain of suffering inflicted on my family. It’s just part of who I am as a person”. - Sara Luterman
17 Jan 2022, 11:03 am
