A method of making a noninvasive molecular control and analysis is described. The method of making the noninvasive molecular control includes, predetermining a positive control for a condition of interest, selecting a cell line with a control marker for the condition of interest, amplifying release of cfDNA from the selected cell line, isolating the released cfDNA from the selected cell line, quantifying the control marker from the isolated cfDNA, determining a volume of the control marker for addition to an isolated control plasma, isolating the control plasma from a control sample, treating the isolated control plasma with a control stabilizer, determining a volume of the control plasma to add to the volume of control marker, combining the volume of the control marker with the isolated control plasma, and analyzing a sample against the noninvasive molecular control to determine the presence or absence of a condition of interest.

The present invention relates to a method of diagnosing and/or prognosing preeclampsia. Specifically, the method involves determining the quantitative level of one or more biomarkers in a biological sample from the subject and either diagnosing preeclampsia; prognosing unstable moderate early-onset preeclampsia; and/or diagnosing preeclampsia and prognosing unstable moderate early-onset preeclampsia in the subject.

This invention teaches a targeted apheresis method of treating a pregnant woman with preeclampsia, or who is predisposed to developing preeclampsia, utilizing immobilized binding agents contained within an apheresis device to remove sVEGFR-1 and sVEGFR-2, and one or more other harmful factors associated with preeclampsia selected from a list that includes: sEndoglin, Endothelin-1, TNF, IL-1, IL-6, IL-12, IL-18, digitalis-like factor, ouabain-like factor, marinobufagenin, .marinobufotoxenin, and telocinobufagin. The binding agents used are antibodies or aptamers or binding peptides. Reducing the concentration of sVEGFR-1, sVEGFR-2 and other harmful factors in the pregnant woman's blood using targeted apheresis will alleviate or delay the symptoms of preeclampsia, and thus postpone premature delivery of the baby so that the baby is born at term or as close to term as possible.

Provided are systems and methods for assessing the presence or risk of obstetrical complications, particularly those related to an angiogenic and anti-angiogenic imbalance. Also provided are methods of treating an angiogenic and anti-angiogenic imbalance with water-soluble statins, such as pravastatin.

Methods and kits for identifying an increased risk of developing preeclampsia in a pregnant woman based on expression pattern of non-coding RNAs in body fluids are provided. In particular, the methods provide information for identifying a pregnant woman as being at risk of developing preeclampsia by analyzing the pattern of non-coding RNAs in body fluids during early stages of pregnancy.

Disclosed herein is a method of identifying and/or addressing incipient preeclampsia in a patient-subject by the steps of (a) performing a bioassay to determine the level of at least one sialyl Lewis antigen in a said patient-subject at about 25 weeks of pregnancy or earlier; (b) performing a bioassay to determine the level of at least one sialyl Lewis antigen in a pregnant non-preeclampsia one or more subjects at about 30 weeks of pregnancy or later, wherein said at least one sialyl Lewis antigen assay is for a sialyl Lewis antigen assayed in step (a) is and if more than one subject is assayed, averaging said results; and (c) managing said patient-subject for preeclampsia, if said level of at least one sialyl Lewis antigen of step (a) is at or greater than about 20% above the level of such sialyl Lewis antigen assayed in step (b).

The invention relates to methods for assessing the risk of miscarriage or embryo implantation failure, and also for monitoring or evaluating the effect of a treatment to reduce the risk of miscarriage or embryo implantation failure using specific biomarkers. The invention also relates to the use of these biomarkers in methods of diagnosing a reproductive disorder in an individual, and also to methods of treating a reproductive disorder. In addition, the biomarkers can further be used in methods of selecting patients for treatment to reduce risk of embryo implantation failure or miscarriage. The invention also relates to kits for use in any of the methods described herein.

Provided herein are methods of detecting or determining aging and/or oxidative damage in tissue, including placental tissue, skin, kidney and brain tissue. One embodiment provides a method for detecting or determining aging in body tissue, comprising measuring one or more markers of aldehyde oxidase 1 (AOX1) expression or activity in a biological sample, wherein the level of AOX1 expression or activity, or of the one or more markers, is indicative of aging in the tissue. Also provided herein are methods of treating a disease or condition associated with ageing or oxidative damage in one or more cells or tissues, comprising administering to a subject in need thereof an inhibitor of AOX1.

The invention relates to a vaginal fluid monitoring device embedded into a feminine sanitary pad, said device comprising a stack of the following elements: An absorbent layer (100) configured to be in proximity to, and collect, a vaginal fluid; and A biosensing system (1000) in fluidic connection with said absorbent layer (100), said biosensing system (1000) comprising: A microfluidic chip (200) configured to perform an immunoassay to detect the presence and/or the concentration of at least one target biomarker comprised in a vaginal fluid; Means (300) for providing a readout of the presence and/or the concentration of said at least one target biomarker; and An electrode array (400) located along the microfluidic chip (200) configured to detect and analyze the flow of said vaginal fluid by impedance means; wherein said immunoassay is configured to detect the presence and/or the concentration of at least one target biomarker indicative of a pre-term birth (PTB) risk and/or premature rupture of membrane (PROM) risk. The invention also relates to a method for detecting at least one target biomarker comprised in a vaginal fluid.

The present disclosure relates to methods for predicting time-to-delivery in pregnant women. The methods include predicting that a pregnant woman will deliver within a predetermined time frame if PAMG-1 is determined to be present at a level above a predetermined detection threshold in a vaginal fluid sample obtained from the pregnant woman. Also provided are methods for determining a patient's risk of preterm labor and/or spontaneous rupture of the chorioamniotic membrane.