Transforming Lives

The early Autism detection test is recommended for use in people with an elevated risk for Autism, such as newborns from those with a previous family history, or where there is concern infants are not meeting developmental milestones. The early Autism detection test does not detect all types of Autism and should be used in addition to routine Autism screening tests recommended by a healthcare provider. The early Autism detection test is intended to detect cellular biophysical signals highly correlated with diagnosis of ASD. Use of the early Autism detection test is not recommended in individuals who are pregnant or undergoing active Autism treatment.

Results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms. A test result of “No Autism Signal Detected” does not rule out Autism; 25% of those with ADOS-diagnosed ASD signal in the neurotypical range. The test interpretation is designed to in this fashion to minimize any false-positive results. A test result of “Autism Signal Detected” requires confirmatory medical diagnostic evaluation or by medically established procedures (e.g. ADOS) to confirm Autism.

If Autism is not clinically confirmed, it could mean that the patient is still too young to manifest symptoms or that Autism is not present or testing was insufficient to detect Autism, including due to a limited skin sample. False-positive (an autism signal detected when autism is not present) and false-negative (a autism signal not detected when autism is present) test results do occur. Rx only.

NeuroQure’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists (CAP). The early Autism detection test was developed, and its performance characteristics were determined by NeuroQure. The early Autism detection test has not yet been cleared or approved by the Food and Drug Administration. NeuroQure’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The early Autism detection test is intended for clinical purposes.