When Dr. Manish Arora’s triplet daughters were babies, he noticed something wasn’t quite right.
“Two were babbling away, and one was not trying to roll over,” he recalls. “Something felt different.” Was it autism?
He and his daughter’s mom filled out questionnaires, sought opinions and spent “thousands of dollars trying to get to the right answer,” Arora says. But the experience led Arora — a professor and vice chair of environmental medicine at Mount Sinai’s school of medicine in New York — to create a new diagnostic aid: the ClearStrand-ASD test from LinusBio.
This test uses strands of a young child’s hair to identify biochemical markers that may indicate autism. Available since February 2025, it’s the first of its kind, backed by peer-reviewed studies and designated a “breakthrough technology” by the FDA. Here’s what parents need to know.
Why does this new test matter?
Autism is currently diagnosed based on observation, often after delays.
“The average diagnosis age is stubbornly stuck at around 4-5 years in the U.S.,” Arora says. But brain development “in the first year and a half of life” is critical. “You’re missing that window of opportunity to deliver therapy.”
ClearStrand-ASD allows testing as early as one month, with results in 3-4 weeks.
“We are not a replacement for any clinicians,” Arora says. “We are just there to support the clinician and the family.”
What is a ‘biochemical marker’?
“A biochemical marker is just like you’d go to your doctor for a diabetes test, or you get a cholesterol test,” Arora explains — something measurable in the body, not based on interpreting behavior.
Current autism screening relies on questionnaires and subjective tools. “I did that for my own daughter,” who’s now a tween, he says. “Surprisingly, there’s a lot of inconsistency.”
ClearStrand-ASD provides a more objective starting point, he says. “All we need is 1 centimeter of hair,” Arora says. “Our AI does pattern recognition over time.”
How does ClearStrand-ASD work?
“The order needs to be prescribed by a healthcare provider,” Arora says. “We connect you with a clinician directly on our website. The entire process can be done remotely.”
Here’s how it works:
- Start the process at clearstrandasd.com
- A clinician reviews your child’s info and, if appropriate, orders the test
- The kit arrives by mail — no chemicals, just a tube
- Snip 5-10 hairs from the back of your child’s head and send them in
- Hair is scanned and opened lengthwise using laser-guided robotics
- Up to 150 million biochemical data points are analyzed
- Results are returned in 3-4 weeks
“You don’t even have to pull the hairs out, you just cut it with a pair of scissors,” Arora notes. “It’s pain-free.”
What do the test results mean?
There are two possible outcomes:
- “No” — autism can be ruled out with high accuracy
“Not no” — autism can’t be ruled out; see a specialist
“We don’t say ‘yes,’” Arora notes. “We say, ‘we cannot rule it out.’”
LinusBio is building a specialist referral network, including telehealth options. “We are even working on offering our patients an appointment within a certain amount of time,” Arora says.
What does it cost?
- Introductory price through June 2025: $499
- Standard price starting July 2025: $749
- Additional $50 off ($449) discount available for Metro Parent readers with code METROMOM
- Not yet covered by insurance, but discussions are underway
- Free and discounted tests are available through Autism Speaks for qualifying families
“We just want it to be accessible,” Arora says.
What kind of research is behind it?
A proof-of-concept was developed at Mount Sinai’s National Institutes of Health-funded lab and has been tested in Sweden, Japan, and California since 2020. ClearStrand-ASD was then validated by LinusBio a CLIA-certified laboratory.
A proof-of-concept was developed at Mount Sinai’s National Institutes of Health-funded lab and tested in Sweden, Japan, and California since 2020. ClearStrand-ASD was then validated by LinusBio, a laboratory certified under federal CLIA standards for clinical testing.
“We’ve gone through many rounds of diligence, including peer-review of journal articles and federal and state government review,” Arora says. “At the end of the day, though, every parent must reach their level of comfort.”
Still, he adds, “The earlier you give intervention, the better that child does on multiple fronts.
“It’s not to deliver bad news sooner. It’s actually to deliver hope sooner.”
A special promotion for ClearStrand-ASD
ClearStrand-ASD is now offered at a special price in honor of Autism Awareness Month 2025, continuing through June — $499 instead of $749. Get an additional $50 off with code METROMOM (enter the code during checkout).
This content is sponsored by LinusBio ClearStrand-ASD. To learn more, visit the ClearStrand-ASD website.
