IP Library Granted Patent US 11,866,783
Granted Patent B2
US 11,866,783 · App. 16/318,658 · Granted Jan 9, 2024

Extracellular mRNA markers of muscular dystrophies in human urine

Inventors: Thurman Wheeler (Boston, MA); Xandra O. Breakefield (Newton Center, MA); Leonora Balaj (Charlestown, MA)
Assignee: The General Hospital Corporation
C12Q1/6883C12Q1/6865G01N33/50C12Q2600/106C12Q2600/156
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Quick Facts
Patent No.
US 11,866,783
App. No.
16/318,658
Granted
Jan 9, 2024
Kind
B2
Abstract

Described herein are methods for diagnosing and monitoring subjects with diseases associated with aberrant splicing, based upon detecting properly spliced isoforms and mis-spliced isoforms in a urine sample from the subject.

Claims (15)

1. A method, comprising:

obtaining a sample comprising urine from a subject who has, or is suspected to have, myotonic dystrophy type 1 (DM1);

isolating extracellular mRNA in the sample;

performing an assay to detect isoforms of mRNAs in the sample, wherein the mRNAs are:

(i) transcripts for muscleblind like splicing regulator 2 (MBNL2); SOS Ras/Rac guanine nucleotide exchange factor 1 (SOS1); cytoplasmic linker associated protein 1 (CLASP1);

muscleblind like splicing regulator 1 (MBNL1); and mitogen-activated protein kinase kinase kinase 4 (MAP3K4), or

(ii) transcripts for MBNL2, MBNL1, SOS1, CLASP1, MAP3K4, and insulin receptor (INSR).

2. A method, comprising:

obtaining a sample comprising urine from a subject who has, or is suspected to have, myotonic dystrophy type 1 (DM1);

isolating extracellular mRNA in the sample;

performing an assay to detect isoforms of mRNAs in the sample, wherein the mRNAs are transcripts for MBNL2; SOS1; CLASP1; MBNL1; and MAP3K4.

3. A method, comprising:

obtaining a sample comprising urine from a subject who has, or is suspected to have, myotonic dystrophy type 1 (DM1);

isolating extracellular mRNA in the sample;

performing an assay to detect isoforms of mRNAs in the sample, wherein the mRNAs are transcripts for MBNL2, MBNL1, SOS1, CLASP1, MAP3K4, and INSR.

Assignments (2)
CONFIRMATORY LICENSE Recorded Jan 4, 2023
From: MASSACHUSETTS GENERAL HOSPITAL
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 062270/0993 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 27, 2019
From: WHEELER, THURMAN; BREAKEFIELD, XANDRA O.; BALAJ, LEONORA
To: THE GENERAL HOSPITAL CORPORATION
Reel/Frame 051125/0675 →
Continuity (2)
Provisional Application 62365139 · Jul 21, 2016
Related Publication 20190284628A1 · Sep 19, 2019