IP Library Granted Patent US 10,670,610
Granted Patent B2
US 10,670,610 · App. 14/407,516 · Granted Jun 2, 2020

Biomarker test for prediction or early detection of preeclampsia and/or HELLP syndrome

Inventors: Adi L. Tarca (Canton, MI); Nandor Than (Grosse Pointe Woods, MI); Gabor Juhasz (Budapest, HU); Adrienna Katalin Kekesi (Budapest, HU); Hamutal Meiri (Tel Aviv, IL); Zoltan Papp (Budapest, HU); Roberto Romero (Detroit, MI)
Assignees: Wayne State University; The United States of America as represented by The Secretary, Department of Health and Human Services Office of Technology Transfer, National Institutes of Health; Semmelweis University; Genesis Theranostix Korlatolt Felelossegu Tarsasag
G01N33/689C12Q1/6883G01N2800/368G01N2800/50
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Quick Facts
Patent No.
US 10,670,610
App. No.
14/407,516
Granted
Jun 2, 2020
Kind
B2
Abstract

Disclosed are specific biomarkers that allow for early testing of preeclampsia/HELLP syndrome. Thus, a method is provided predicting preeclampsia in a pregnant woman. Also disclosed is a kit comprising means for assaying a sample from a pregnant woman for the concentrations of the specific biomarkers.

Claims (18)

1. A method for treating preeclampsia or HELLP syndrome, said method comprising:

administering an effective amount of an agent which prevents or reduces symptoms of preeclampsia or HELLP syndrome in a female and/or fetus subject, said administering taking place before said symptoms manifest in the female and/or fetus, wherein the subject has been identified by a method comprising:

obtaining a biological sample from a pregnant human female before the 15 th week of pregnancy;

determining levels of three or more biomarkers in the biological sample in a panel, wherein the panel comprises apolipoprotein H precursor and at least two other biomarkers selected from the group consisting of complement factor B, gelsolin isoform a precursor, hornerin, fetuin B, hemopexin precursor, fms-related tyrosine kinase 1, hydroxysteroid (17-β) dehydrogenase 1, leptin, lectin galactoside-binding soluble 14, pappalysin 2, and placenta-specific 1;

generating a dataset based on the determined levels; and

diagnosing the presence or risk of developing preeclampsia or HELLP syndrome in the subject based on a biostatistical analysis and comparison of the dataset to a reference dataset corresponding to known presence.

2. The method of claim 1 for treating preeclampsia wherein the panel comprises apolipoprotein H precursor and at least two other biomarkers selected from the group consisting of complement factor B, hornerin, hemopexin precursor, hydroxysteroid (17-β) dehydrogenase 1, lectin galactoside-binding soluble 14, and pappalysin 2; wherein the administering of the agent prevents or reduces symptoms of preeclampsia in the subject.

3. A method according to claim 1 , wherein the biological sample is a blood sample.

4. A method according to claim 1 , wherein the biological sample is a body fluid, secretion, or excretion sample other than blood.

5. A method according to claim 1 , wherein the biological sample is an amniotic fluid sample.

6. A method according to claim 1 , wherein the biological sample is fetal cells obtained invasively or non-invasively.

7. A method according to claim 1 , wherein the biological sample is a placental sample.

8. A method according to claim 1 , wherein the biological sample is obtained before the 14 th week of pregnancy, before the 13 th week of pregnancy, before the 12 th week of pregnancy, before the 11 th week of pregnancy, before the 10 th week of pregnancy, before the 9 th week of pregnancy, before the 8 th week of pregnancy, before the 7 th week of pregnancy, or before the 6 th week of pregnancy.

9. The method of claim 1 wherein the levels of the three or more biomarkers are determined by a protein-based assay method.

10. The method of claim 1 wherein the levels of the three or more biomarkers are determined by using specific antibodies produced against the biomarkers whereby the biological sample is contacted with the antibodies and binding between the biomarkers and the antibodies is detected.

11. The method of claim 1 wherein the accuracy of risk assessment is more than 75%.

12. A method according to claim 1 , wherein the biological sample is a cervicovaginal fluid, saliva, or urine sample.

13. A method according to claim 1 , said administering taking place before the 16 th week of pregnancy.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 7, 2022
From: THAN, NÁNDOR GÁBOR; TARCA, ADI L.
To: GENESIS THERANOSTIX KORLÁTOLT FELELÖSSÉGÜ TÁRSASÁG
Reel/Frame 062016/0106 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 6, 2022
From: WAYNE STATE UNIVERSITY
To: THAN, NÁNDOR GÁBOR; TARCA, ADI L.
Reel/Frame 061995/0424 →
CONFIRMATORY LICENSE Recorded Jul 1, 2016
From: WAYNE STATE UNIVERSITY
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 039239/0962 →
Priority Claims (1)
HU 201200368 · Jun 15, 2012 · national
Continuity (2)
Provisional Application 61699193 · Sep 10, 2012
Related Publication 20160187347A1 · Jun 30, 2016