Biomarker test for prediction or early detection of preeclampsia and/or HELLP syndrome
Inventors
TARCA, Adi L. • THAN, Nandor • Juhasz, Gabor • KEKESI, Adrienna Katalin • Meiri, Hamutal • Papp, Zoltan • Romero, Roberto
Assignees
Genesis Theranostix Korlatolt Feleloessegue Tarsasag • GENESIS THERANOSTIX KORLATOLT FELELOSSEGU TARSASAG • Semmelweis Egyetem • Office of Technology Transfer
Publication Number
US-10670610-B2
Publication Date
2020-06-02
Expiration Date
2033-06-13
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Abstract
Disclosed are specific biomarkers that allow for early testing of preeclampsia/HELLP syndrome. Thus, a method is provided predicting preeclampsia in a pregnant woman. Also disclosed is a kit comprising means for assaying a sample from a pregnant woman for the concentrations of the specific biomarkers.
Core Innovation
The invention provides biomarker combinations useful for the early prediction and/or detection of preeclampsia and/or HELLP syndrome in pregnant women. It enables assessment of specific biomarkers in biological samples, even early in gestation, to determine the presence or risk of these conditions, thereby facilitating timely therapeutic interventions. Additionally, the invention contemplates kits comprising means for assaying levels of select biomarkers from a pregnant woman's biological sample for diagnosis or risk assessment.
The problem addressed is the lack of reliable predictive tests for preeclampsia and HELLP syndrome, conditions that are major causes of maternal and perinatal mortality and morbidity worldwide. Existing diagnostic methods require symptoms to manifest typically after 20 weeks, while early molecular markers have been inconclusive or contradictory due to the heterogeneous molecular background of these syndromes. The invention overcomes these limitations by providing a unique gene, protein, and hormone biomarker panel detectable as early as 7-9 weeks of gestation, identified using a systems biological approach.
Claims Coverage
The claims encompass two main inventive features that detail methods for early identification and treatment of preeclampsia or HELLP syndrome using a panel of biomarkers, and the biological samples and timing related to such methods.
Method for treating preeclampsia or HELLP syndrome based on early biomarker detection
A method involving administering an agent to prevent or reduce symptoms of preeclampsia or HELLP syndrome in a female and/or fetus before symptoms manifest, where the subject is identified by obtaining a biological sample before the 15th week of pregnancy and determining levels of three or more biomarkers in a panel including apolipoprotein H precursor and at least two other specific biomarkers from a defined group, generating a dataset, and diagnosing risk through biostatistical comparison.
Refined biomarker panel and therapeutic intervention for preeclampsia
A method wherein the biomarker panel comprises apolipoprotein H precursor and at least two other biomarkers selected from complement factor B, hornerin, hemopexin precursor, hydroxysteroid (17-β) dehydrogenase 1, lectin galactoside-binding soluble 14, and pappalysin 2, and wherein administering the agent prevents or reduces symptoms of preeclampsia in the subject.
Variants of biological samples and assay methods for biomarker detection
Methods specifying that biological samples can be blood, other body fluids, secretions, excretions, amniotic fluid, fetal cells obtained invasively or non-invasively, or placental samples, obtained at varying times before the 15th week of pregnancy, and with biomarker level determination by protein-based assays using specific antibodies.
Overall, the claims cover methods of early detection and treatment of preeclampsia or HELLP syndrome using a defined panel of biomarkers measured in specific biological samples obtained prior to symptom onset, as well as variations in sample type and assay methods.
Stated Advantages
Enables early prediction and/or detection of preeclampsia and HELLP syndrome before clinical symptoms develop.
Provides a biomarker panel with high sensitivity and specificity for detecting preeclampsia, improving diagnostic accuracy over previous inconclusive tests.
Facilitates timely therapeutic intervention to prevent or reduce symptoms in both the pregnant female and fetus.
Documented Applications
Predicting and early detecting preeclampsia and HELLP syndrome in pregnant women using a biomarker panel.
Assessing the need for treatment regimens based on biomarker levels in biological samples obtained early in pregnancy.
Use of kits comprising detection mechanisms for biomarkers to enable diagnosis and treatment decisions.
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