The StrandDx™ ASD device uses laser ablation inductively coupled plasma mass
spectrometry (LA-ICPMS) to measure and generate a temporal profile of a panel of
15 individual metal ions in a single strand of human hair and an algorithm to provide
a qualitative interpretation of test results derived from these measurements.
The device is intended:
• to aid in diagnosis of autism spectrum disorder (ASD) in patients aged 18 months to
21 years, and
• to assess the likelihood of ASD in children < 18 months old, who are at risk of ASD
and require evaluation for ASD. A negative result below the predictive threshold is
associated with the absence of ASD.
StrandDx™ ASD is not a stand-alone diagnostic. Results are intended to be interpreted
by a health care provider in the context of the patient medical history and results of the
screening evaluation for ASD. This test is to be performed only at Linus Biotechnology
Inc. by trained laboratory personnel at a single laboratory site.