# US 2024/0201207 A1 · Method and kit for predicting preeclampsia

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- Number: US 2024/0201207 A1
- Document ID: US20240201207A1
- Status: Published application
- Kind: A1
- Application number: 18/287,532
- Filed: 2022-04-19
- Published: 2024-06-20
- Earliest claimed: 2021-04-19
- Applicants: Max-DelbrüCk-Centrum FüR Molekulare Medizin In Der Helmholtz-Gemeinschaft
- Inventors: Florian Herse; Louise Bjorkholt Andersen; Andreas Busjahn; Ralf Dechend
- Web page: https://patentgrep.com/patent/US20240201207A1

## CPC

- G01N 33/92: involving lipids, e.g. cholesterol {, lipoproteins, or their receptors (steroid hormones G01N33/743)}
- G01N 2333/475: Assays involving growth factors
- G01N 2333/912: transferring phosphorus containing groups, e.g. kinases (2.7)
- G01N 2800/368: Pregnancy complicated by disease or abnormalities of pregnancy, e.g. preeclampsia, preterm labour
- G01N 2800/50: Determining the risk of developing a disease
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

The invention pertains to a method for the prediction of preeclampsia in a pregnant female human subject until the end of gestational week 16 of pregnancy based on metabolites from a blood sample obtained from said subject. According to the invention, the method comprises the following steps: measuring the level of the following metabolites in the sample: 14,15-DHET, 13-HODE, 10,11-EDP, 21-HDHA, and 11,12-DHET, and concluding based on the measured level whether the subject is likely to develop preeclampsia.

## Claims

### Claim 1

A method for the prediction of preeclampsia in a pregnant female human subject until the end of gestational week 16 of pregnancy based on metabolites from a blood sample obtained from said subject, comprising:
measuring the level of the following metabolites in the sample: 14,15-DHET, 13-HODE, 10,11-EDP, 21-HDHA, and 11,12-DHET, and
concluding based on the measured level whether the subject is likely to develop preeclampsia.

### Claim 2 (depends on 1)

The method of claim 1, further comprising:
measuring the level of at least one of the following metabolites in the sample:
7,8-EDP, 16,17-DiHDPA, 12,13-DiHOME, 11,12-DHET, 9,10-DiHOME, 5,6-DiHETE; 10-HDHA, 11,12-EET, 15-HETE, 7,8-DiHDPA, PGE2, 14,15-EET, 18-HETE, EODAcis, EODAtrans, and 13,14-DiHDPA.

### Claim 3 (depends on 1)

The method of claim 1, further comprising:
measuring the level of 11-HETE.

### Claim 4 (depends on 1)

The method of claim 1, wherein the level of the following metabolites in the sample is measured: 14,15-DHET, 13-HODE, 10,11-EDP, 21-HDHA, and 11-HETE;
5,6-DiHETE; 11,12-DHET; 13,14-DiHDPA; 12,13-DiHOME; 9,10-DiHOME; and 18-HETE.

### Claim 5 (depends on 1)

The method of claim 1, wherein the level of the following metabolites in the sample is measured: 14,15-DHET, 13-HODE, 10,11-EDP, 21-HDHA, and 11-HETE;
5,6-DiHETE; 11,12-DHET; 13,14-DiHDPA; 12,13-DiHOME; 9,10-DiHOME; 18-HETE; and 14,15-EET.

### Claim 6 (depends on 1)

The method of claim 1, wherein the level of sFLT-1 and/or PlGF is measured.

### Claim 7 (depends on 1)

The method of claim 1, wherein the method is performed within the first trimester of pregnancy.

### Claim 8 (depends on 1)

The method of claim 1, wherein the measuring of metabolite levels is performed using a mass spectrometer.

### Claim 9 (depends on 1)

The method of claim 1, wherein the decision whether the subject has preeclampsia comprises the step of training a classification algorithm on a training set of cases and controls, and applying it to measured metabolite levels, wherein the classification method is a random forest method, a support vector machine (SVM), or a K-nearest neighbor method (K-NN).

### Claim 10

(canceled)

### Claim 11

A kit for the prediction of preeclampsia in a female human subject based on metabolites obtained from a blood sample, comprising samples of the following metabolites:
14,15-DHET, 13-HODE, 10,11-EDP, 21-HDHA, and 11,12-DHET, in particular for use as a standard in mass spectrometry.

### Claim 12 (depends on 11)

The kit of claim 11, wherein the sample carries a marker that allows for the differentiation from the naturally occurring metabolite in mass spectrometry, in particular wherein the marker is deuterium.

### Claim 13 (depends on 11)

The kit of claim 11, further comprising
Instructions for treating the development of preeclampsia,
a means or reagent for extracting eicosanoids, in particular a separation column,
a chromatography column, and/or
a quality control specimen.

### Claim 14

(canceled)

### Claim 15

A method for preparing a metabolite profile that is indicative of the presence or absence of preeclampsia in a subject, comprising:
isolating metabolites from a blood sample obtained from the subject, and
measuring the level of the following metabolites in the sample: 14,15-DHET, 13-HODE, 10,11-EDP, 21-HDHA, and 11,12-DHET.

### Claim 16

(canceled)