US 11,987,846 B2 · Biomarker pairs for predicting preterm birth

Abstract

The disclosure provides a pair of isolated biomarkers selected from the group consisting of IBP4/SHBG, IBP4/PSG3, IBP4/LYAM1, IBP4/IGF2, CLUS/IBP3, CLUS/IGF2, CLUS/LYAM1, INHBC/PSG3, INHBC/IGF2, PSG2/LYAM1, PSG2/IGF2, PSG2/LYAM1, PEDF/PSG3, PEDF/SHBG, PEDF/LYAM1, CD14/LYAM1, and APOC3/LYAM1, wherein the pair of biomarkers exhibits a change in reversal value between pregnant females at risk for pre-term birth and term controls. Also provided is a method of determining probability for preterm birth in a pregnant female, the method comprising measuring in a biological sample obtained from the pregnant female a reversal value for at least one pair of biomarkers selected from the group consisting of IBP4/SHBG, IBP4/PSG3, IBP4/LYAM1, IBP4/IGF2, CLUS/IBP3, CLUS/IGF2, CLUS/LYAM1, INHBC/PSG3, INHBC/IGF2, PSG2/LYAM1, PSG2/IGF2, PSG2/LYAM1, PEDF/PSG3, PEDF/SHBG, PEDF/LYAM1, CD14/LYAM1, and APOC3/LYAM1 to determine the probability for preterm birth in the pregnant female.

Claims18

Dependent claims

A method for providing prophylactic treatment of preterm birth in a pregnant human patient, the method comprising:

(i) measuring in a biological sample obtained from said patient a panel of isolated biomarkers comprising IBP4 and SHBG, wherein measuring comprises subjecting the biological sample to a proteomics work-flow comprised of mass spectrometry (MS);
(ii) calculating a risk score using a reversal value for IBP4/SHBG;
and
(iii) administering to said patient, where said risk score is above a reference risk score, a treatment regimen comprising a progesterone treatment, cervical cerclage, serial cervical length measurements, or an antenatal corticosteroid.

1 more element

Dependencies are inferred from the claim text.

Facts

Application

17/189,048Filed 1 Mar 2021 · continuation

Priority

19 Jun 2015

Published

US 2021/0180135 A117 Jun 2021

Granted

21 May 2024

Term ends

Not estimatedThe source records don’t support an estimate.

Classification12 codes

C12Q 1/6883
Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes: for diseases caused by alterations of genetic material
C07K 14/47
From vertebrates: from mammals
G01N 33/6848
General methods of protein analysis not limited to specific proteins or families of proteins: methods of protein analysis involving mass spectrometry
G01N 33/689
Involving proteins, peptides or amino acids: related to pregnancy or the gonads

Family

Application62/182,349Us provisional application · filed 19 Jun 2015

Application62/387,420Us provisional application · filed 24 Dec 2015

Application62/290,796Us provisional application · filed 3 Feb 2016

Application15/186,322Parent of this continuation · filed 17 Jun 2016

Application16/380,938Parent of this continuation · filed 10 Apr 2019

US 10,392,665 B2Parent of this continuation · filed 27 Aug 2019

US 2021/0180135 A1Pre-grant publication · published 17 Jun 2021

US 10,961,584 B2Parent of this continuation

US 2017/0022565 A1Published application

US 2020/0071761 A1Published application

US 11,987,846 B2This patent

From the US filing history. Foreign family members aren’t listed.

Biomarker pairs for predicting preterm birth

Life of this patent

Biomarker pairs for predicting preterm birth

Life of this patent

Abstract

Claims18