Biomarkers and methods for predicting preterm birth

A technology of biomarkers and derivatives, applied in the field of personalized medicine

Active Publication Date: 2017-04-19
SERA PROGNOSTICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Current strategies for risk assessment are based on obstetric and medical history and clinical examination, but these strategies identify only a low proportion of women at risk of preterm delivery

Method used

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  • Biomarkers and methods for predicting preterm birth
  • Biomarkers and methods for predicting preterm birth
  • Biomarkers and methods for predicting preterm birth

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0167] Example 1. Establishment of a sample set for the discovery and validation of preterm biomarkers

[0168] Establishment of standard protocols governing the conduct of proteomic evaluation of preterm birth risk (PAPR) clinical studies. The protocol also stipulates that samples and clinical information may be used to study other pregnancy complications in some subjects. Samples were obtained from women at 11 Internal Review Board (IRB)-approved sites throughout the United States. After providing informed consent, serum and plasma samples were obtained, along with relevant information on patient demographics, past medical and pregnancy history, current pregnancy history, and concurrent drug therapy. After delivery, data are collected on maternal and infant conditions and complications. Serum and plasma samples were processed according to protocols requiring standardized refrigerated centrifugation, aliquoting of samples into 0.5 mL 2-D barcoded freezing vials and subseque...

Embodiment 2

[0175] Example 2. Analysis of transitions to identify biomarkers of preterm birth I

[0176] The goal of these analyzes was to examine the data collected in Example 1 to identify transitions and proteins that are predictive of preterm birth. The specific analyzes used were (i) Cox time-event analysis and (ii) a model with preterm birth as the binary categorical dependent variable. For all Cox analyses, the dependent variable was gestational age at time of event (where event was preterm birth). For the purposes of the Cox analysis, preterm subjects had an event on the day of delivery. Full-term subjects were examined on the day of delivery. Gestational age on the day of sample collection was a covariate in all Cox analyses.

[0177] Assay data were previously adjusted for run order and batch removal, and log transformed. Values ​​for gestational age at sample collection were adjusted as follows. Only controls (non-preterm subjects) were used to regress the jump for gestati...

Embodiment 3

[0197] Example 3. Study II to Identify and Validate Biomarkers of Preterm Birth

[0198] Further studies were performed using essentially the same methods described in the examples above, unless noted below. In this study, 2 gestational matched controls were used for each of the 28 cases and 56 matched controls, all samples were from the early gestational window (17-22 weeks).

[0199] Samples were processed in 4 batches, each containing 7 cases, 14 matched controls and 3 HGS controls. The 14 most abundant serum samples among the serum samples were removed by MARS14 as described in Example 1. The depleted serum was then reduced with dithiothreitol, alkylated with iodoacetamide, and hydrolyzed overnight at 37°C with trypsin at a trypsin:protein ratio of 1:20. After trypsin hydrolysis, samples were desalted on Empore C18 96-well solid phase extraction plates (3M Company) and lyophilized. Desalted samples were redissolved in reconstitution solution containing 5 internal standa...

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PUM

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Abstract

The disclosure provides biomarker panels, methods and kits for determining the probability for preterm birth in a pregnant female. The present disclosure is based, in part, on the discovery that certain proteins and peptides in biological samples obtained from a pregnant female are differentially expressed in pregnant females that have an increased risk of developing in the future or presently suffering from preterm birth relative to matched controls. The present disclosure is further based, in part, on the unexpected discovery that panels combining one or more of these proteins and peptides can be utilized in methods of determining the probability for preterm birth in a pregnant female with relatively high sensitivity and specificity. These proteins and peptides disclosed herein serve as biomarkers for classifying test samples, predicting a probability of preterm birth, monitoring of progress of preterm birth in a pregnant female, either individually or in a panel of biomarkers.

Description

[0001] This application claims priority to U.S. Provisional Patent Application No. 61 / 919,586, filed December 20, 2013, and U.S. Provisional Patent Application No. 61 / 798,504, filed March 15, 2013, each in its entirety Incorporated herein by reference. [0002] The present invention relates generally to the field of personalized medicine, and more particularly, to compositions and methods for determining the probability of preterm birth in a pregnant woman. Background technique [0003] 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 9789241503433 (2012). An estimated 1 million babies die each year fro...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/48
CPCG01N2800/60G01N2800/368G01N33/689G01N2800/52Y02A90/10C07K4/12
Inventor 都尔林·爱德华·希科克约翰·杰伊·博尼费斯格雷戈里·查尔斯·克里驰菲尔德特蕾西·克里斯蒂纳·弗莱舍
Owner SERA PROGNOSTICS
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