Methods for diagnosing pervasive development disorders, dysautonomia and other neurological conditions

• US 9,377,459 B2
• Filed: 10/30/2014
• Issued: 06/28/2016
• Est. Priority Date: 11/16/2000
• Status: Active Grant

• Current Assignee: Curemark LLC
• Original Assignee: Curemark LLC
• Inventors: Fallon, Joan M.
• Primary Examiner(s): NAVARRO, ALBERT MARK
• Application Number:
  US14/528,715
• Publication Number:
  US 20150140550A1
• Time in Patent Office: 607 Days
• US Class Current: 1/1
• CPC Class Codes: C12Q 1/6883 for diseases caused by alterations of genetic material
• CPC Class Codes: C12Q 1/689 for bacteria
• CPC Class Codes: C12Q 1/6893 for protozoa
• CPC Class Codes: C12Q 1/6895 for plants, fungi or algae
• CPC Class Codes: G01N 2469/10 Detection of antigens from microorganism in sample from host
• CPC Class Codes: G01N 2800/28 Neurological disorders
• CPC Class Codes: G01N 2800/2835 Movement disorders, e.g. Parkinson, Huntington, Tourette
• CPC Class Codes: G01N 33/569 for microorganisms, e.g. protozoa, bacteria, viruses
• CPC Class Codes: G01N 33/56905 Protozoa
• CPC Class Codes: G01N 33/56911 Bacteria
• CPC Class Codes: G01N 33/56983 Viruses
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

Methods for aiding in the diagnosis of disorders including, but not limited to, PDDs (Pervasive Development Disorders), Dysautonomic disorders, Parkinson'"'"'s disease and SIDS (Sudden Infant Death Syndrome). In one aspect, a diagnosis method comprises analyzing a stool sample of an individual for the presence of a biological marker (or marker compound) comprising one or more pathogens, which provides an indication of whether the individual has, or can develop, a disorder including, but not limited to, a PDD, Dysautonomia, Parkinsons disease and SIDS. Preferably, the presence of one or more pathogens is determined using a stool immunoassay to determine the presence of antigens in a stool sample, wherein such antigens are associated with one or more pathogens including, but not limited to, Giardia, Cryptosporidium, E. histolytica, C. difficile, Adenovirus, Rotavirus or H. pylori.

Claims

1. A method for determining if an individual has a Familial Dysautonomia, comprising the steps of:

obtaining a stool sample from the individual;

analyzing the stool sample with a stool immunoassay for the presence or absence of an antigen associated with a pathogen;

detecting the level of chymotrypsin present in the stool sample; and

determining that the individual has a Familial Dysautonomia based on the presence of the antigen and an abnormally low level of chymotrypsin in the stool sample.

2. The method of claim 1, wherein the pathogen comprises Helicobacter pylori.

3. The method of claim 1, wherein the pathogen comprises Cryptosporidium.

4. The method of claim 1, wherein the pathogen comprises Giardia.

5. The method of claim 1, wherein the pathogen comprises Rotavirus.