# US 2018/0024138 A1 · Frizzled-4 mutation indicator of retinopathy and intrauterine growth restriction

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- Number: US 2018/0024138 A1
- Document ID: US20180024138A1
- Status: Published application
- Kind: A1
- Application number: 15/656,558
- Filed: 2017-07-21
- Published: 2018-01-25
- Earliest claimed: 2016-07-21
- Assignees: Retinal Solutions LLC
- Inventors: Kimberly Drenser; Michael T. Trese; Antonio Capone
- Web page: https://patentgrep.com/patent/US20180024138A1

## CPC

- G01N 33/689: {related to pregnancy or the gonads}
- A61K 38/1709: {from mammals}
- G01N 2800/368: Pregnancy complicated by disease or abnormalities of pregnancy, e.g. preeclampsia, preterm labour
- G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
- 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)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

A method for determining the necessity of a pre-term birth treatment is provided based on obtaining a biological sample from a subject. The biological sample is analyzed for the presence of (P33S;P168S) Frizzled4 (Fzd4) gene variation. The subject or a fetus thereof is then treated for a proclivity to pre-term birth. The Fzd4 protein itself can also be analyzed for the (P33S;P168S) Fzd4 mutation.

## Claims

### Claim 1

A method for determining the necessity of a pre-term birth treatment comprising:
obtaining a biological sample from a subject;
analyzing the biological sample for the presence of (P33S;P168S) Frizzled4 (Fzd4) gene variation; and
treating the subject for pre-term birth complications.

### Claim 2 (depends on 1)

The method of claim 1 wherein the subject is a fetus.

### Claim 3 (depends on 1)

The method of claim 1 wherein the subject is a pregnant female.

### Claim 4 (depends on 3)

The method of claim 3 wherein the subject is a human.

### Claim 5 (depends on 1)

The method of claim 1 where the biological sample is a blood sample.

### Claim 6 (depends on 1)

The method of claim 1 where the biological sample comprises leukocytes.

### Claim 7 (depends on 1)

The method of claim 1 where the biological sample is amniotic fluid.

### Claim 8 (depends on 1)

The method of claim 1 where the biological sample is a mucosal tissue swab.

### Claim 9 (depends on 1)

The method of claim 1, wherein said subject is one of: cow, horse, sheep, pig, goat, chicken, cat, dog, mouse, guinea pig, hamster, rabbit, or rat.

### Claim 10

A method of pre-term birth treatment comprising:
contacting a biological sample from a pregnant subject with an antibody directed against a (P33S;P168S) Frizzled4 protein to produce an antibody-protein complex\;
detecting with Western blot or an ELISA the presence of the antibody-protein complex; and
treating the pregnant subject or a fetus therein to mitigate pre-term birth of the fetus.

### Claim 11 (depends on 10)

The method of claim 10 wherein the treating comprises administration of norrin protein.

### Claim 12 (depends on 10)

The method of claim 10 further comprising receiving financial remuneration for performing the steps of contacting and detecting.

### Claim 13 (depends on 10)

The method of claim 10 wherein the first antibody is detectably labeled.

### Claim 14 (depends on 10)

The method of claim 10 wherein the biological sample is obtained during the first trimester or second trimester of pregnancy

### Claim 15 (depends on 10)

The method of claim 10 further comprising comparing the quantity of said antibody-protein complex to the quantity of said antibody-protein complex in control sample from a donor lacking P33S;P168S mutations in Fzd4 protein.

### Claim 16

A method for treating retinopathy of prematurity (ROP) comprising:
obtaining a biological sample from a subject;
analyzing the biological sample for the presence of (P33S;P168S) Frizzled4 (Fzd4) gene variation; and
treating the subject for ROP.