Diagnostic biomarker to predict women at risk for preterm delivery

a biomarker and diagnostic technology, applied in the field of preterm delivery, can solve the problems of few, if any, effective diagnostic biomarkers, and achieve the effects of reducing and increasing the risk of preterm delivery

Inactive Publication Date: 2014-02-20
CEDARS SINAI MEDICAL CENT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0011]In various embodiments, a higher or lower expression level of the cytokine, cytokine receptor, cytokine receptor antagonist, chemokine, chemokine receptor, and / or chemokine receptor antagonist compared to a control can indicate that the woman is at an increased risk of preterm delivery. In various embodiments, the higher or lower expression level of the cytokine, cytokine receptor, cytokine receptor antagonist, chemokine, chemokine receptor, and / or chemokine receptor antagonist can be at least one to three times higher or lower compared to the levels of the control. In various embodiments, the level of the higher or lower expression of the cytokine, cytokine receptor, cytokine receptor antagonist, chemokine, chemokine receptor, and / or chemokine receptor antagonist can be indicative of a low, medium, or high risk of preterm delivery. In various embodiments, a statistically significantly higher or lower expression of the cytokine, cytokine receptor, cytokine receptor antagonist, chemokine, chemokine receptor, and / or chemokine receptor antagonist compared to a control can indicate that the woman is at an increased risk of preterm delivery.

Problems solved by technology

Preterm delivery is one of the most important fetal health problems in the United States today.
Currently, there are few, if any diagnostic biomarkers available that effectively identify women who are going to deliver preterm.

Method used

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  • Diagnostic biomarker to predict women at risk for preterm delivery

Examples

Experimental program
Comparison scheme
Effect test

example 1

Biomarker Assay

[0045]Peripheral blood mononuclear cells (PBMC) from non-pregnant (at least 5-6 years post-partum) women with history of preterm or full term delivery, in addition to the microbial component lipopolysaccharide (LPS)-induced cytokine expression profile were examined. PBMC were separated from whole blood using Ficoll gradient. The cells were counted and equal numbers of cells were plated in 24 well plates. PBMC were treated with cortisol (50 or 300 ug / ml) or media for 1 hour prior to stimulation with LPS (0, 1, or 100 ug / ml) for 24 hours. The PBMC were lysed and the supernatant was examined for inflammatory and anti-inflammatory cytokine expression by using Bioplex technology (Bio-rad). The inventors found that during the non-pregnant state IL10, IL13 and IL1Ra expression was lower in the PBMC obtained from women whom had previous preterm delivery, and that those biomarkers may be measured to identify women who were at risk for preterm delivery in the future.

[0046]In th...

example 2

Establishment of Cut Off Points

[0047]Many samples were above or below the detection for some of the endpoints. Cut off points were established for each cytokine measured (Table 1). If a sample was out of the range of detection, a default value was assigned to the sample as indicated below.

TABLE 1The establishment of cut off points for out of range values.Out ofFraction ofRangeSamples out ofCytokineLimit of DetectionSet ValueDetection RangeIL-1raall samples within levelsn / a 0 / 99of detectionIL-2LL = 0.500.2510 / 99IL-4LL = 0.140.08 6 / 99IL-5LL = 0.900.582 / 99IL-8UL = 95,000100,00079 / 99IL-10all samples within levelsn / a 0 / 99of detectionIL-12LL = 0.330.1519 / 99IL-13LL = 0.170.08 8 / 99GM-CSFLL = 1.180.6011 / 99IFN-gLL = 1.210.60 5 / 99TNF-aall samples within levelsn / a 0 / 99of detectionLL = Lower Limit;UL = Upper Limit

[0048]All samples that were below the range of detection for IL-2, IL-4, IL-13, and IFN-g were from the two subjects with a history of preterm delivery. Of the 11 samples assayed that w...

example 3

Statistical Analysis

[0049]Empirical means and standard errors for each cytokine and treatment group are presented herein. Here, the averages of replicate measures were calculated first for each subject. The mean and SEM were then taken across each treatment group.

[0050]All raw data was tested via the Kolmogorov-Smirnov test to determine if the data followed a normal distribution. Log-transformations were performed for all data found to have a non-normal distribution prior to further statistical analysis. For each cytokine, a mixed effects model was used to examine all data for significant effects with the outcome variable as the cytokine concentration; the fixed predictor variables as LPS concentration, cortisol concentration, and delivery status (pre- or full-term); and the random effect due to the replicate data points. To test the interaction of the three fixed predictor variables on cytokine concentration, both first and second level interactions ware added to each cytokine mode...

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Abstract

The invention relates to biomarkers associated with preterm delivery. More specifically, the invention provides methods of measuring biomarkers including but not limited to cytokines, cytokine receptors, cytokine receptor antagonists, chemokines, chemokine receptors, and / or chemokine receptor antagonists found in women that are at risk for preterm delivery. The diagnostic methods may be performed on whole blood.

Description

FIELD OF INVENTION[0001]This invention relates to preterm delivery. More specifically, the invention provides biomarkers and methods of using biomarkers for determining preterm delivery risk.BACKGROUND[0002]All publications herein are incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. The following description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.[0003]Preterm delivery is one of the most important fetal health problems in the United States today. Approximately one in eight newborns is delivered preterm and the incidence of prematurity has not decreased in the last 20 years. Most preterm babies, if they survive, often...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): G01N33/68
CPCG01N33/689G01N33/6863G01N33/6866G01N33/6869G01N2800/368
Inventor EQUILS, OZLEMSIMMONS, CHARLES F.
Owner CEDARS SINAI MEDICAL CENT
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