# US 2015/0147281 A1 · Caries risk test for predicting and assessing the risk of disease

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- Number: US 2015/0147281 A1
- Document ID: US20150147281A1
- Status: Published application
- Kind: A1
- Application number: 14/543,131
- Filed: 2014-11-17
- Published: 2015-05-28
- Earliest claimed: 2003-04-01
- Assignees: Proactive Oral Solutions, Inc.; University of Southern California
- Applicants: Proactive Oral Solutions, Inc.; University of Southern California
- Inventors: Patricia A. Denny; Paul C. Denny; Mahvash Navazesh
- Web page: https://patentgrep.com/patent/US20150147281A1

## CPC

- G01N 33/6893: {related to diseases not provided for elsewhere}
- G01N 2333/42: Lectins, e.g. concanavalin, phytohaemagglutinin
- G01N 2333/4724: Lectins
- G01N 2800/18: Dental and oral disorders
- G01N 2800/50: Determining the risk of developing a disease
- 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

Provided are methods, test devices, and diagnostic kits for predicting, assessing, and diagnosing the risk of a disease using salivary analysis. The methods comprise providing a whole (unfractionated) saliva sample from a subject; contacting an aliquot of the saliva with two or more lectins under conditions that allow the two or more lectins to bind to a lectin-binding component of the saliva; detecting the amount of bound lectin; and comparing the amount of bound lectin to the amount known to bind a saliva sample from a control patient, to predict the risk of a disease in the subject. Also provided are methods for reducing the risk of a disease and a method for assessing the risk of the disease at a defined level.

## Claims

### Claim 1

A method for predicting the risk of disease in a subject, said method comprising:
obtaining an unfractionated saliva sample from said subject;
contacting an aliquot of said saliva with two or more lectins under conditions that allow said two or more lectins to bind to two or more respective lectin-binding components of said saliva;
detecting the amounts of bound lectins; and
comparing the amounts of bound lectins to the respective amounts known to bind a saliva sample from a control subject, wherein the amounts of bound lectins are indicative of the risk of said disease.

### Claim 2

A method for preventing or reducing the risk of a disease, the method comprising:
obtaining an unfractionated saliva sample from a subject;
contacting an aliquot of said saliva with two or more lectins under conditions that allow said two or more lectins to bind respectively to two or more lectin-binding components of said saliva;
detecting the amounts of bound lectins;
comparing the amounts of bound lectins to the respective amounts known to bind a saliva sample from a control subject, wherein the amounts of bound lectins are proportional to the risk of a disease in said subject; and
administering a therapeutic reagent to said subject when the content of the components in said saliva are above or below the respective levels contained in a normal control.

### Claim 3

A kit for detecting disease, the kit comprising:
means for collecting a saliva sample;
means for measuring the amounts of two or more lectin-binding components in said sample; and
an oral fluid standard for comparing with the amounts of said components in said sample.