Methods and systems for determining a pregnancy-related state of a subject

Abstract

The present disclosure provides methods and systems directed to cell-free identification and/or monitoring of pregnancy-related states. A method for identifying or monitoring a presence or susceptibility of a pregnancy-related state of a subject may comprise assaying a cell-free biological sample derived from said subject to detect a set of biomarkers, and analyzing the set of biomarkers with an algorithm to determine the presence or susceptibility of the pregnancy-related state.

What is claimed is: 
     
         1 . A method for determining that a subject or a fetus of said subject has or is at risk of having a pregnancy-related state, comprising assaying transcripts in a cell-free biological sample derived from said subject to detect a set of biomarkers, and computer processing said set of biomarkers to determine that said subject or said fetus has or is at risk of having said pregnancy-related state with an accuracy as determined using a plurality of test samples corresponding to (1) a first plurality of subjects having said pregnancy-related state and (2) a second plurality of subjects who do not have said pregnancy-related state or who have negative clinical indications for said pregnancy-related state, that is correctly determined to have, not have, be at risk of, or not be at risk of, said pregnancy-related state. 
     
     
         2 . The method of  claim 1 , further comprising assaying said transcripts derived from said cell-free biological sample derived from said subject to detect said set of biomarkers. 
     
     
         3 . The method of  claim 2 , further comprising reverse transcribing ribonucleic acid (RNA) molecules derived from said transcripts to produce complementary deoxyribonucleic acid (cDNA) molecules; and assaying said cDNA molecules to detect said set of biomarkers. 
     
     
         4 . The method of  claim 2 , wherein said transcripts are assayed with nucleic acid sequencing. 
     
     
         5 . The method of  claim 1 , wherein said pregnancy-related state is selected from the group consisting of pre-term birth and preeclampsia. 
     
     
         6 . The method of  claim 5 , wherein said pregnancy-related state comprises pre-term birth. 
     
     
         7 . The method of  claim 5 , wherein said pregnancy-related state comprises preeclampsia. 
     
     
         8 . The method of  claim 1 , wherein said cell-free biological sample is selected from the group consisting of a cell-free ribonucleic acid (cfRNA) sample, a blood sample, a plasma sample, a serum sample, a urine sample, a saliva sample, and an amniotic fluid sample. 
     
     
         9 . The method of  claim 8 , wherein said cell-free biological sample comprises a blood sample or a plasma sample. 
     
     
         10 . The method of  claim 1 , wherein said computer processing comprises using an algorithm to process said set of biomarkers.