Assay to measure midkine or pleiotrophin level for diagnosing a growth

Patent metadata

Field	Value
Publication number	US-9664682-B2
Application number	US-201314646078-A
Country	US
Kind code	B2
Filing date	Nov 15, 2013
Priority date	Nov 20, 2012
Publication date	May 30, 2017
Grant date	May 30, 2017

Abstract

The invention provides methods and kits for diagnosing a growth in a subject by providing a sample of a growth taken from a subject, determining the level of midkine or pleiotrophin in the sample by an immunoassay, and comparing the level of midkine or pleiotrophin determined from the sample with a control. An increased level of midkine or pleiotrophin in the sample as compared to the control is diagnostic of a malignant growth, whereas an equivalent or decreased level of midkine or pleiotrophin in the sample as compared to the control is diagnostic of a benign growth. Growth refers to, for example, papillary thyroid cancer (PTC).

First claim

The invention claimed is:

1. A method of treating a growth in a subject comprising:
(a) providing a sample of a growth obtained from thyroid tissue of a subject,
(b) analyzing the sample by an immunoassay to determine the concentration of pleiotrophin protein in the sample,
(c) analyzing the sample by an immunoassay to determine the concentration of thyroglobulin protein in the sample,
(d) determining the ratio of pleiotrophin protein concentration to thyroglobulin protein concentration (PTN/Tg) in the sample,
(e) comparing the ratio of pleiotrophin protein concentration to thyroglobulin protein concentration determined from the sample with a control,
(f) providing a diagnosis of the growth as a malignant growth after determining an increased ratio of pleiotrophin protein concentration to thyroglobulin protein concentration determined from the sample as compared to the control and
(g) performing a thyroidectomy on the subject,
wherein the control is the ratio of pleiotrophin protein concentration to thyroglobulin protein concentration in a benign growth.

2. The method of claim 1 , wherein the growth is a thyroid nodule.

3. The method of claim 1 , wherein the growth is a tumor.

4. The method of claim 1 , which further comprises histological or cytological examination of the growth.

5. The method of claim 1 , wherein the immunoassay of (b) is a sandwich enzyme-linked immunosorbent assay (ELISA) which comprises a step of contacting the sample with a solution comprising an antibody that specifically binds to human pleiotrophin protein.

6. The method of claim 5 , wherein the antibody is conjugated to a label that is biotin, a radionuclide, a fluorescent molecule, a chemiluminescent molecule, or an enzyme.

7. The method of claim 5 , wherein the solution comprises a polymer.

8. The method of claim 7 , wherein the polymer is poly-L-lysine.

9. The method of claim 8 , wherein the concentration of poly-L-lysine in the solution is 10 μg/mL.

Assignees

• Us Health

Inventors

• Baron Jeffrey
• Jee Youn Hee

Classifications

• G01N33/57585 Primary

  involving compounds identifiable in body fluids · CPC title

• G01N33/57557 Primary

  of other specific parts of the body, e.g. brain · CPC title

• G01N2333/475

  Assays involving growth factors · CPC title

• G01N33/543

  with an insoluble carrier for immobilising immunochemicals · CPC title

• A61B10/02

  Instruments for taking cell samples or for biopsy {(A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48)} · CPC title