IP Library Granted Patent US 11,891,665
Granted Patent B2
US 11,891,665 · App. 16/616,122 · Granted Feb 6, 2024

Compositions for differentiating latent autoimmune diabetes in adults from childhood-onset type 1 diabetes and methods for diagnosing and treating disease

Inventors: Struan Frederick Grant (Swarthmore, PA); Rajashree Mishra (Philadelphia, PA)
Assignee: THE CHILDREN'S HOSPITAL OF PHILADELPHIA
C12Q1/6883C12Q1/6881G01N33/564G01N33/74C12Q2600/112C12Q2600/156C12Q2600/172G01N2800/042G01N2800/50G01N2800/60
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Quick Facts
Patent No.
US 11,891,665
App. No.
16/616,122
Granted
Feb 6, 2024
Kind
B2
Abstract

Compositions for the identification of patients at risk for the development of latent autoimmune diabetes, and methods of use thereof, for the diagnosis and treatment of the same.

Claims (12)

1. A method for treating a subject with an altered risk of Latent autoimmune diabetes (LADA) over Type 1 Diabetes (T1D), the method comprising;

a) providing a biological sample comprising nucleic acids obtained from a subject having diabetic symptoms;

b) genotyping said sample for MHC HLA haplotypes HLA-DQB1*0302, HLA-DQB1*0201, HLA-DRB1*1501, HLA-B*3906 and HLA-A*11;

c) identifying from said genotyping that the said subject lacks HLA-B*3906 and HLA-A*11 biomarkers, absence of said HLA-B*3906 and HLA-A*11 being indicative of an increased risk of LADA over T1D; and

d) after steps b) and c), treating the subject with an agent which modulates LADA symptoms.

2. The method of claim 1 , further comprising monitoring the subject by

a) obtaining at least one additional blood sample from said subject; and

b) detecting in said at least one additional sample one or more autoimmune disease and/or diabetes biomarkers.

3. The method of claim 1 , wherein said subject has not been previously diagnosed with either T1D or LADA.

4. The method of claim 1 , further comprising detecting in said sample one or more autoimmune disease biomarkers, wherein said autoimmune biomarker is one or more autoantibody selected from Glutamic acid decarboxylase autoantibodies (GADA), Islet cell autoantibodies (ICA), IA-2-protein tyrosine phosphatase-like protein autoantibodies (IA-2A), Insulin autoantibodies (IAA), Zinc transporter (ZnT8) autoantibodies.

5. The method of claim 1 , wherein levels of one or more of insulin, glucagon and blood sugar are monitored in said subject.

6. The method of claim 1 , wherein the haplotypes HLA-DQB1*0302, HLA-DQB1*0201, HLA-DRB1*1501 are present in said sample.

Assignments (2)
CONFIRMATORY LICENSE Recorded Sep 8, 2023
From: CHILDREN'S HOSP OF PHILADELPHIA
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 064844/0034 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 21, 2020
From: GRANT, STRUAN; MISHRA, RAJASHREE
To: THE CHILDREN'S HOSPITAL OF PHILADELPHIA
Reel/Frame 053827/0291 →
Continuity (2)
Provisional Application 62510926 · May 25, 2017
Related Publication 20200123611A1 · Apr 23, 2020