IP Library Patent Application 15873067
Patent Application
App. No. 15/873,067

MIRNAS AS DIAGNOSTIC BIOMARKERS TO DISTINGUISH BENIGN FROM MALIGNANT THYROID TUMORS

Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US None
App. No.
15/873,067
Abstract

Embodiments concern methods and compositions for distinguishing benign from malignant thyroid tumor in a patient based on the expression levels of one or more miRNAs.

Claims (28)

1 - 219 . (canceled)

220 . A method of treating a patient with a malignant thyroid tumor, the method comprising:

a) amplifying nucleic molecules from a patient thyroid sample;

b) measuring the level of expression in the thyroid sample of a group of microRNA selected from the group consisting of: miRNAs: miR-375, miR-146b-5p, miR-204-5p, miR-7-5p, and miR-141-3p;

c) comparing the level of expression of each biomarker miRNA measured in a) to the level of expression of another biomarker miRNA measured in a),

wherein mir-375 is compared to the level of expression of miR-7-5p, miR-204-5p, or miR-141-3p, or

wherein miR-146b-5p is compared to the level of expression of miR-7-5p, miR-204-5p, or miR-141-3p;

c) calculating a diagnostic score implemented by a computer that indicates the probability that the thyroid sample is malignant, wherein the diagnostic score is based on one or more of the comparisons in b),

wherein the sample is identified as malignant if the probability indicates the thyroid sample is malignant; and

treating the patient identified to have a malignant thyroid sample by administering radioactive iodine, radiation, chemotherapy to the patient identified to have a malignant thyroid sample or performing a full or partial thyroidectomy on the patient identified to have a malignant thyroid sample.

221 . The method of claim 220 , wherein the thyroid sample is a cystic fluid sample.

222 . The method of claim 220 , wherein the thyroid sample is a fine need aspirate sample.

223 . The method of claim 220 , wherein the diagnostic score is calculated using weighted coefficients for each of the measured expression levels of biomarker miRNAs.

224 . The method of claim 220 , wherein the diagnostic score identifies the thyroid sample as malignant when the expression level of at least one measured miRNA is increased in a malignant thyroid sample relative to the expression level of a benign thyroid sample and the expression level of at least a second measured miRNA is decreased in a malignant thyroid sample relative to the expression level of a benign thyroid sample,

wherein the increased miRNA is miR-141-3p, miR-146b-5p, or miR-375 and the decreased miRNA is miR-7-5p or miR-205-5p.

225 . The method of claim 220 , further comprising generating a malignant data set and a benign data set using logistic regression model and fitting the diagnostic score into either the malignant data set or the benign data set, wherein the diagnostic score that fits in the malignant data set is identified as a malignant thyroid sample or the diagnostic score that fits in the benign data set is identified as a benign thyroid sample.

226 . The method of claim 220 , wherein the treating comprises administering radioactive iodine to the patient identified to have a malignant thyroid sample.

227 . The method of claim 220 , wherein the treating comprises administering radiation to the patient identified to have a malignant thyroid sample.

228 . The method of claim 220 , wherein the treating comprises administering chemotherapy to the patient identified to have a malignant thyroid sample.

229 . The method of claim 220 , wherein the treating comprises performing a partial thyroidectomy on the patient identified to have a malignant thyroid sample.

230 . The method of claim 220 , wherein the treating comprises performing a full thyroidectomy on the patient identified to have a malignant thyroid sample.

231 . A method of producing a labeled set of nucleic acid molecules, the method comprising:

a) amplifying nucleic molecules from a patient thyroid sample; and

b) labeling a group of microRNA molecules selected from the group consisting of: miRNAs: miR-375, miR-146b-5p, miR-204-5p, miR-7-5p, and miR-141-3p.

232 . The method of claim 231 , wherein the label is a fluorescent label.

234 . The method of claim 231 , wherein the amplifying step labels the group of microRNA.

235 . The method of claim 231 , wherein the amplifying step comprises contacting the sample with labeled primers.

236 . The method of claim 235 , wherein the labeled primers are fluorescent labeled primers.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 8, 2018
From: ASURAGEN, INC.
To: INTERPACE DIAGNOSTICS, LLC
Reel/Frame 047092/0052 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 8, 2018
From: BEAUDENON-HUIBREGTSE, SYLVIE; WYLIE, DENNIS; ADAI, ALEX
To: ASURAGEN, INC
Reel/Frame 047203/0409 →