North Brunswick-based LinusBio, a leader in exposomic sequencing and precision health, announced that ClearStrand-ASD, its first-of-its-kind biochemical test designed to help rule out autism spectrum disorder (ASD), is now available for children up to age 10.
This broadens the test’s previously validated use beyond children under 48 months, making it the only objective autism rule-out test that spans from infancy through childhood.
The expansion is supported by data from a global study of 1,697 participants, which has been submitted for publication in a peer-reviewed journal.
ClearStrand-ASD is the first and only biochemical screening test for autism spectrum disorder, intended to help health care providers rule out autism when it is a concern.
Available by prescription in 49 states, the noninvasive test requires only a strand of hair and can be used in children as young as 1 month.
The test is performed in LinusBio’s CLIA-certified laboratory, where proprietary robotics and lasers analyze hundreds of data points along the hair strand to identify biological, metabolic and molecular patterns associated with ASD.
With 90% sensitivity and a 95% negative predictive value, ClearStrand-ASD is highly accurate in ruling out autism, supporting earlier clinical decision-making and timely access to intervention.
“From the beginning, our goal has been to support families and health care providers by providing them with a screening tool that keeps improving as the science advances,” said Manish Arora, Ph.D., founder and CEO of LinusBio.
“As we generate more data and deepen our understanding of the biology, we can expand the test to help a broader group of families and clinicians.
“Extending access from early childhood to children up to age 10 is an important step toward reaching more families who may benefit from earlier biological insight.”
By expanding the test’s validated age range, LinusBio will reach more families and provide earlier biological insight during developmental evaluations.
