Preeclampsia biomarkers and related systems and methods
AssigneeProgenity, Inc.
InventorsMatthew COOPER, Sharat SINGH, Karen A.F. COPELAND, Lyndal HESTERBERG, Amin R. MAZLOOM, Mohammad ABBASI, Richard Giulio DEL MASTRO
Life of this patent
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Abstract
Disclosed herein are methods, kits, tests, and systems for detecting, predicting, monitoring, or ruling out preeclampsia in pregnant women. Also provided herein are novel diagnostic markers, methods of data analysis, assay formats, and kits employing such markers to improve one or more characteristics of a test for identifying or ruling out preeclampsia based on biomarkers from patient samples.
Claims154
A method for avoiding unnecessary treatment of preeclampsia, the method comprising:
- (a) contacting a biological sample that has been collected from a pregnant human female with a plurality of different probes, wherein the plurality of different probes comprises probes with specific affinity for four or more proteins selected from proteins listed in Table A or Table B;
- (b) determining, based on binding of the plurality of different probes to corresponding proteins, an amount or concentration for each of the four or more proteins;
- and
- (c) proceeding with treatment of said pregnant human in a manner that avoids unnecessary treatment of preeclampsia based at least in part on the amounts or concentrations of the four or more proteins determined in step (b).
A method, such as a laboratory method, for detecting and/or quantifying a plurality of proteins in a sample from a pregnant human female, the method comprising:
- contacting a biological sample from a pregnant human female with a plurality of probes, wherein the plurality of probes comprises probes with specific affinity for four or more proteins selected from the proteins listed in Table A or Table B;
- detecting the presence and/or quantity of the four or more proteins based on binding of the plurality of different probes to corresponding proteins.
A method for managing a pregnant human subject and identifying the pregnant human subject as not at risk for preeclampsia for a specified period of time, the method comprising:
- (a) identifying, via a test having (1) a specificity of greater than 80% and (2) a sensitivity of greater than 85%, the pregnant subject as not at risk for developing preeclampsia within the specified period of time, wherein the specified period of time is between one week and six weeks;
- and
- (b) managing the pregnant human subject identified as not at risk for developing preeclampsia within the specified period of time by proceeding with ambulant monitoring treatment of said pregnant patient without treating the patient for preeclampsia.
A method of treating a pregnant human subject, the method comprising:
- obtaining an indicium generated, at least in part, from a determination of levels for four or more proteins listed in Table A or Table B;
- and
- changing a clinical regimen for the pregnant human subject based, at least in part, on the obtained indicium.
A mixture comprising:
- a fluid sample from a pregnant female subject;
- a first plurality of different probes, wherein the first plurality of different probes comprises different probes, each with specific affinity for four or more proteins selected from proteins listed in Table A or Table B.
A reaction plate comprising a plurality of reaction wells, wherein the plurality of reaction wells comprises:
- a first well comprising (1) a first portion of a biological sample from a pregnant human subject, wherein the biological sample was obtained from a pregnant human subject after 20 weeks of gestation, and (2) a first set of probes for binding to PlGF;
- a second well comprising (1) a second portion of the biological sample from the pregnant human subject, and (2) a second set of probes for binding to sFlt1, endoglin, pappalysin 2 (PAPP-A2), or decorin;
- a third well comprising (1) a third portion of the biological sample from the pregnant human subject, and (2) a third set of probes for binding to KIM1, (2) programmed cell death 1 ligand 1 (CD274), or decorin;
- and
- a fourth well comprising (1) a fourth portion of the biological sample from the pregnant human subject, and (2) a fourth set of probes for binding to CLEC4A, FGF21, TFF2, or HGF.
A kit for ruling out preeclampsia in a pregnant female subject, the kit comprising:
- (a) probes for determining the levels of four or more proteins selected from the proteins listed in Tables 6 and 7;
- (b) wherein the kit is designed to measure the levels of no more than 20, no more than 15, no more than 10, nor more than 8, no more than 7, no more than 6, nor more than 5, or no more than 4 proteins.
A system for ruling out preeclampsia in a pregnant female subject for a specified period of time, the system comprising:
- a processor;
- an input module for inputting levels of at least four proteins in a biological sample, wherein the at least four proteins are selected from Tables 6 and 7;
- a computer readable medium containing instructions that, when executed by the processor, perform a first algorithm on the input levels of the at least four proteins;
- and
- an output module providing one or more indicia based on the input levels of the at least four proteins, wherein the one or more indicia are indicative of the subject not having preeclampsia for at least a specified period of time.
Dependencies are inferred from the claim text.