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Biomarkers for predicting preterm birth due to preterm premature rupture of membranes versus idiopathic spontaneous labor

A technology for biomarkers and premature rupture of membranes, applied in biological testing, biomaterial analysis, biochemical equipment and methods, etc., can solve problems that have not led to clinically useful tests

Pending Publication Date: 2019-08-30
SERA PROGNOSTICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Despite numerous studies identifying women at risk, PTB prediction algorithms based solely on clinical and demographic factors or using measured serum or vaginal biomarkers have not resulted in clinically useful tests

Method used

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  • Biomarkers for predicting preterm birth due to preterm premature rupture of membranes versus idiopathic spontaneous labor
  • Biomarkers for predicting preterm birth due to preterm premature rupture of membranes versus idiopathic spontaneous labor
  • Biomarkers for predicting preterm birth due to preterm premature rupture of membranes versus idiopathic spontaneous labor

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0134] Example 1. PPROM and PTL phenotypes are characterized by differences in underlying biochemical pathways

[0135] Target:

[0136] To examine potential biological pathways of maternal biomarkers associated with preterm birth (PTB) due to preterm premature rupture of membranes (PPROM) versus idiopathic spontaneous labor (PTL)

[0137] Research design:

[0138] A second nested case-control analysis of the proteomic evaluation of the preterm birth risk study. We analyzed clinical characteristics and samples from prospective collections from 195 subjects (39 PTB Pathway analysis categorized proteins differentially expressed in PPROM or PTL versus term (AUC > 0.64 and p-value < 0.05) or in PPROM versus PTL.

[0139] method

[0140] Second Analysis of the Proteomic Evaluation of the Preterm Birth Risk Study (Clinicaltrials.gov Identifier: NCT01371019)

[0141] Anticipated serum collections at 191 / 7-206 / 7 weeks of pregnancy: 39 SPTB < 37 weeks: 17 PPROM and 22 PTL, 156 mat...

Embodiment 2

[0161] Example 2. Further studies on PPROM and PTL phenotypes

[0162] The study of Example 1 was repeated with a large number of analytes and for different data subsets based on gestational age. In addition to univariate analysis, this example includes the evaluation of two-analyte reversal (up-regulated protein / down-regulated protein) for PPROM versus term, PTL versus term, and PPROM versus PTL. Finally, pairs of reversals were evaluated for predicting overall preterm birth by combining high-performing PPROM-versus-term reversals with high-performing PTL-versus-term reversals, and using the combination of highly selective reversals for each phenotype to use To distinguish PPROM from PTL.

[0163] Research design:

[0164] A second nested case-control analysis of the proteomic evaluation of the preterm birth risk study. We analyzed clinical characteristics and maternal serum from samples collected prospectively at 119-153 days of gestation. Using the entire cohort (119-15...

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Abstract

The present invention provides compositions and methods for predicting the probability of preterm birth in a pregnant female. The present invention provides a composition comprising one or more biomarkers selected from the group consisting of the biomarkers set forth in Figures 1 and 2 and Tables 1 through (3), (6) through (38), and (44) through (68). In one embodiment, the invention provides a method of determining probability for preterm birth in a pregnant female, optionally preterm birth associated with preterm premature rupture of membranes (PPROM) or preterm birth associated idiopathic spontaneous labor (PTL), the method comprising measuring in a biological sample obtained from the pregnant female one or biomarkers selected from one or more of the biomarkers set forth in Figures 1 and 2 and Tables 1 through (3), (6) through (38), and (44) through (68) to determine the probability for preterm birth in said pregnant female.

Description

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 449,862, filed January 24, 2017, and U.S. Provisional Patent Application No. 62 / 371,666, filed August 5, 2016, each of which is incorporated in its entirety The contents are incorporated herein by reference. [0002] The present invention relates generally to the field of precision medicine, and more particularly, to compositions and methods for determining the probability of preterm birth in a pregnant female animal. [0003] Background of the invention [0004] According to the World Health Organization, an estimated 15 million babies are born prematurely (before the 37th full week of pregnancy) each year. According to reliable data, the rate of preterm births is increasing in almost all countries. See, World Health Organization; March of Dimes; The Partnership for Maternal, Newborn & Child Health; Save the Children, Born too soon: the global action report on preterm birth , ISBN 978924...

Claims

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Application Information

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IPC IPC(8): C12Q1/6883G01N33/53C40B40/10G01N33/566
CPCC40B40/10C12Q1/6883C12Q2600/156C12Q2600/158G01N33/689G01N2560/00G01N2800/368G01N33/6848G01N2570/00G01N2800/60
Inventor 约翰·杰伊·博尼费斯朵加·伯查德格雷格·查尔斯·克里驰菲尔德特蕾西·克里斯蒂纳·弗莱舍都尔林·爱德华·希科克许谦
Owner SERA PROGNOSTICS
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