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US 12,710,431 B2Granted
Diagnostic for childhood risk of autism spectrum disorder
AssigneesArizona Board of Regents on behalf of Arizona State University, Rensselaer Polytechnic Institute
InventorsJames B. Adams, Juergen Hahn, Haiwei Gu
Life of this patent
Estimating the term…
Abstract
Provided herein are methods of obtaining and applying measurements of metabolites to diagnosing ASD in a subject, particularly children, with high specificity and sensitivity. The metabolites can be measured in urine, serum, and whole blood samples.
Claims12
A method of treating Autism Spectrum Disorder (ASD) in a subject suspected of having or at risk of having ASD, the method comprising:
- (a) in a biological sample obtained from the subject, measuring or having measured a level of each of at least two metabolites in combination wherein the at least two metabolites in combination are selected from the group consisting of:
- 4-Hydroxy-3-methylbenzoic acid and Tryptamine;
- and 4-Hydroxy-3-methylbenzoic acid and 5-Hydroxytryptophan;
- (b) comparing the measured level of each metabolite in the selected combination against a control metabolite level for each metabolite, wherein the control level for each metabolite is determined by measuring a metabolite level in a control, typically developing (TD) subject, wherein the comparing comprises calculating the Type I false positive rate (FPR) and Type II false negative rate (FNR) errors for the selected combination of metabolites using Fisher's Discriminant Analysis (FDA) or logistic regression;
- (c) indicating the subject as having or at risk of ASD when, for the selected combination, the Type I error is about or below 20%, and the Type II error is about or below 20%;
- and
- (d) administering to the subject identified as having or at risk of ASD, a treatment selected from the group consisting of:
- (i) a medication selected from an antipsychotic drug, a selective serotonin re-uptake inhibitor (SSRI), a tricyclic, a psychoactive or anti-psychotic medication, a stimulant, an anti-anxiety medication, or an anticonvulsant;
- (ii) a nutritional supplementation;
- and
- (iii) a composition comprising fecal microbiota from a healthy neurotypical human donor.
8 more elements
A method of treating Autism Spectrum Disorder (ASD) in a subject suspected of having or at risk of having ASD, the method comprising:
- administering to the subject a treatment, wherein the subject has been determined as having or at risk of ASD by having a Type I error of about or below 20%, and a Type II error of about or below 20% for a level of each of two metabolite in a selected combination of at least two metabolites in a biological sample obtained from the subject, wherein two metabolites in combination are selected from the group consisting of:
- 4-Hydroxy-3-methylbenzoic acid and Tryptamine;
- and 4-Hydroxy-3-methylbenzoic acid and 5-Hydroxytryptophan;
- and wherein the treatment is selected from:
- (i) a medication selected from an antipsychotic drug, a selective serotonin re-uptake inhibitor (SSRI), a tricyclic, a psychoactive or anti-psychotic medication, a stimulant, an anti-anxiety medication, or an anticonvulsant;
- (ii) a nutritional supplementation;
- and
- (iii) a composition comprising fecal microbiota from a healthy neurotypical human donor.
5 more elements
Dependencies are inferred from the claim text.