US 10,209,253 B2Granted

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

AssigneeCuremark, LLC

InventorJoan M. Fallon

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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.

Claims26

Dependent claims

A method for determining if an individual has, or can develop, a Pervasive Development Disorder (PDD), comprising the steps of:

detecting a level of chymotrypsin in a stool sample obtained from the individual;
analyzing the stool sample obtained from the individual with a stool immunoassay to determine the presence or absence of one or more antigens associated with a Clostridium difficile, and to determine the presence or absence of one or more antigens associated with one or more pathogens selected from the group consisting of a Helicobacter pylori, an Entamoeba histolytica, and a combination thereof;
detecting whether the one or more one or more antigens associated with the Clostridium difficile is present in the stool sample, and detecting whether one or more antigens associated with one or more pathogens selected from the group consisting of the Helicobacter pylori, the Entamoeba histolytica, and a combination thereof is present in the stool sample;
and
determining that the individual has, or can develop, a PDD when the presence of one or more antigens associated with Clostridium difficile is detected, and when the presence of one or more antigens associated with the one or more pathogens selected from the group consisting of the Helicobacter pylori, the Entamoeba histolytica, and a combination thereof is detected.

2 more elements

Dependencies are inferred from the claim text.

Facts

Application: 15/164,493Filed 25 May 2016 · continuation
Priority: 16 Nov 2000
Published: US 2016/0266113 A115 Sep 2016
Granted: 19 Feb 2019
Term ends: Not estimatedThe source records don’t support an estimate.

Classification15 codes

G01N 33/56911
For microorganisms, e.g. protozoa, bacteria, viruses: bacteria
C12Q 1/6883
Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes: for diseases caused by alterations of genetic material
C12Q 1/689
For detection or identification of organisms: for bacteria
C12Q 1/6893
For detection or identification of organisms: for protozoa

Family

Application60/249,239Us provisional application · filed 16 Nov 2000
Application09/990,909Parent of this division · filed 16 Nov 2001
Application13/208,963Parent of this division · filed 12 Aug 2011
US 8,030,002 B2Parent of this division · filed 4 Oct 2011
Application14/037,652Parent of this continuation · filed 26 Sep 2013
US 8,580,522 B2Parent of this division · filed 12 Nov 2013
Application14/528,715Parent of this continuation · filed 30 Oct 2014
US 8,921,054 B2Parent of this continuation · filed 30 Dec 2014
US 2016/0266113 A1Pre-grant publication · published 15 Sep 2016
US 9,377,459 B2Parent of this continuation
Application14/037,652Parent of this division
US 2002/0081628 A1Published application
US 2012/0003628 A1Published application
US 2014/0170637 A1Published application
US 2015/0140550 A1Published application
US 10,209,253 B2This patent

From the US filing history. Foreign family members aren’t listed.