Application US20190041391 AI Biotech/Diagnostics: Cardio

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Nx Prenatal Inc.

Application US20190041391

Published 2019-02-07

Use Of Circulating Microparticles To Stratify Risk Of Spontaneous Preterm Birth

The present disclosure relates to proteomic biomarkers of spontaneous preterm birth, proteomic biomarkers of term birth, and methods of use thereof. In particular, the present disclosure provides tools for determining whether a pregnant subject is at an increased risk for premature delivery, as well as tools for decreasing a pregnant subject's risk for premature delivery.

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9 Independent Claims

1. A method for assessing risk of spontaneous preterm birth for a pregnant subject, the method comprising: a. preparing a microparticle-enriched fraction from a blood sample from the pregnant subject; b. determining a quantitative measure of a panel of microparticle-associated proteins in the fraction, wherein the panel comprises at least three proteins selected from the proteins of Table 1 or Table 2; and c. assessing the risk of spontaneous preterm birth based on the measure.
3.-19. (canceled)
22.-25. (canceled)
35.-43. (canceled)
44. A method comprising administering to a pregnant subject characterized as having a panel of microparticle-associated proteins indicative of an increased risk of spontaneous preterm birth, an effective amount of a treatment designed to reduce the risk of spontaneous preterm birth, wherein the panel comprises at least three proteins selected from the proteins of Table 1 or Table 2.
47. A method comprising: a. preparing a microparticle-enriched fraction from a blood sample from the pregnant subject; and b. determining a quantitative measure of a panel of microparticle-associated proteins in the fraction, wherein the panel comprises at least three proteins selected from the proteins of Table 1 or Table 2.
49.-78. (canceled)
79. A method comprising: a) preparing a microparticle-enriched fraction from plasma or serum of a pregnant subject at from 8 to 14 weeks of gestation; b) using selected reaction monitoring mass spectrometry, determining a quantitative measure of one or more proteins in the fraction, wherein the proteins are selected from the proteins of Tables 1, 2, 4, 5, 7, 8, or 9; and c) executing a classification rule of a classification system which rule, based on values including the quantitative measures, classifies the subject as being at risk of spontaneous preterm birth, wherein the classification system, in a receiver operating characteristic (ROC) curve, has an area under the curve (AUC) of at least 0.6.
80.-85. (canceled)