# US 9,429,583 B2 · System and method for quantifying fragile X mental retardiation 1 protein in tissue and blood samples

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- Number: US 9,429,583 B2
- Document ID: US9429583B2
- Status: Granted
- Kind: B2
- Application number: 14/153,674
- Filed: 2014-01-13
- Published: 2014-05-08
- Granted: 2016-08-30
- Earliest claimed: 2011-06-10
- Assignees: The Research Foundation for Mental Hygiene, Inc.
- Applicants: Research Foundation For Mental Hygiene, Inc.
- Inventors: Giuseppe LaFauci; William T. Brown; Richard Kascsak
- Web page: https://patentgrep.com/patent/US9429583B2

## CPC

- G01N 33/6896: {Neurological disorders, e.g. Alzheimer's disease}
- G01N 33/533: with fluorescent label
- G01N 33/6812: {Assays for specific amino acids}
- G01N 2800/30: Psychoses; Psychiatry
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

A system and method for the detection and quantification of fragile X mental retardation protein (FMRP) in human tissue and blood samples. The system includes several high avidity monoclonal antibodies that may be provided on Xmap microspheres to capture FMRP from a tissue or blood specimen. The resulting complex is reacted with a polyclonal anti-FMRP rabbit antibody and then mixed with an anti-rabbit IgG antibody conjugated to phycoerythrin. Fluorescence emitted from the resulting complex is a function of the amount of FMRP present in the specimen.

## Claims

### Claim 1

An assay system for detecting a fragile X mental retardation protein in a human tissue sample, comprising:
a monoclonal mouse antibody that binds to SEQ. ID NO. 3;
a polyclonal antibody that binds to a second, different epitope of the fragile X mental retardation protein; and
a third antibody that binds to said polyclonal antibody and is conjugated to a fluorescent compound.

### Claim 2 (depends on 1)

The assay system of claim 1, wherein said monoclonal antibody does not bind to fragile X related protein number one or fragile X related protein number two.

### Claim 3 (depends on 1)

The assay system of claim 1, wherein the polyclonal antibody comprises a polyclonal rabbit antibody.

### Claim 4 (depends on 3)

The assay system of claim 3, wherein the polyclonal antibody binds to SEQ. ID NO. 1.

### Claim 5 (depends on 1)

The assay system of claim 1, wherein said third antibody is an anti-immunoglobulin G antibody.

### Claim 6

An assay system for detecting a fragile X mental retardation protein in a human tissue sample, comprising:
a monoclonal antibody that binds to a first epitope of the human fragile X mental retardation protein;
a polyclonal antibody that binds to a second, different epitope of the fragile X mental retardation protein; and
a third antibody that binds to said polyclonal antibody and is conjugated to a fluorescent compound;
wherein the monoclonal antibody comprises a monoclonal mouse antibody that binds to SEQ. ID NO. 3, the polyclonal antibody comprises a polyclonal rabbit antibody that binds to SEQ. ID NO. 1, and the third antibody is an anti-rabbit immunoglobulin G antibody.

### Claim 7 (depends on 1)

The assay system of claim 1, wherein the monoclonal antibody is coupled to a substrate.

### Claim 8 (depends on 7)

The assay system of claim 7, wherein the substrate comprises beads.

### Claim 9 (depends on 8)

The assay system of claim 8, wherein the fluorescent compound is phycoerythrin.

### Claim 10 (depends on 1)

The assay system of claim 1, wherein the assay comprises an enzyme-linked immunosorbent assay (ELISA).