Systems and methods to predict risk for preterm labor and/or preterm birth
Inventors
TARCA, Adi L. • Erez, Offer • Chaiworapongsa, Tinnakorn • Hassan, Sonia S. • Romero, Roberto
Assignees
Wayne State University • US Department of Health and Human Services • Office of Technology Transfer
Publication Number
US-10802030-B2
Publication Date
2020-10-13
Expiration Date
2038-04-20
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Abstract
Provided are systems and methods to identify subjects at risk for preterm labor and/or preterm birth. The systems and methods utilize biomarkers. Also provided are systems and methods for decreasing the risk of preterm labor by administering a treatment following a positive risk identification.
Core Innovation
The invention provides systems and methods to identify subjects at risk for preterm labor (PTL) utilizing biomarkers. It offers prediction of PTL, particularly less than 37 weeks gestation, less than 35 weeks gestation, or between 8 and 14 weeks gestation. Biomarkers such as CAMK2A, CAMK2B, CAMK2D, BMP-1, and angiostatin are leveraged in these predictive methods. Furthermore, the invention includes systems and methods for decreasing PTL risk by administering a treatment following a positive risk identification.
Preterm birth, defined as birth before 37 weeks of pregnancy, presents significant health challenges including neonatal morbidity, mortality, and long-term disabilities. Existing screening methods for PTL risk, such as cervical length measurement and fetal fibronectin detection, have limitations in reliability and timing. Current diagnostic tests can be complex, involving multiple procedures such as protein assays combined with ultrasound, and can be subjective and unreliable. False positives and negatives from these methods can lead to unnecessary treatments or missed opportunities to improve outcomes.
There is a clear need for simpler, more reliable tests that can identify women at risk of preterm delivery early in pregnancy, before 14 weeks of gestation. The present disclosure fulfills this need by providing protein biomarker-based systems and methods that predict risk of PTL with better performance without requiring multiple measurement procedures. These methods include obtaining a biological sample from a pregnant subject and assaying one or more protein biomarkers to predict PTL risk, enabling early therapeutic intervention.
Claims Coverage
The patent contains two main independent claims focusing on methods for detecting biomarkers in samples from pregnant subjects between 8 and 14 weeks of gestation to predict risk of preterm labor and/or preterm birth.
Biomarker-based detection of preterm labor risk from plasma or serum sample
A method including obtaining a plasma or serum sample from a pregnant human subject in the 8th to 14th week of gestation, contacting the sample with binding ligands that bind biomarkers CAMK2A, CAMK2B, CAMK2D, BMP-1, and angiostatin (or alternatively with CAMK2A, CAMK2B, and BMP-1), and detecting binding of these ligands with the respective biomarker proteins.
Assaying biomarker expression levels from serum or plasma sample for risk prediction
A method comprising assaying a serum or plasma sample obtained from a pregnant subject in the 8th to 14th week of gestation or earlier for expression levels of biomarker proteins selected from (A) CAMK2A, CAMK2B, CAMK2D, BMP-1, and angiostatin or (B) CAMK2A, CAMK2B, and BMP-1 to predict risk of preterm labor and/or preterm birth.
The independent claims cover methods for early pregnancy biomarker detection using specific protein panels including CAMK2A, CAMK2B, CAMK2D, BMP-1, and angiostatin to predict risk for preterm labor and/or birth, as well as corresponding biomarker expression assays in maternal plasma or serum samples.
Stated Advantages
The systems and methods provide a simple and reliable test early in pregnancy to predict risk of preterm labor before 14 weeks gestation without requiring multiple measurement procedures.
The invention enables identification of women at risk for preterm delivery with better prediction performance compared to existing subjective and unreliable diagnostics.
Early identification of risk allows for administration of prophylactic or therapeutic treatments to reduce the chance of preterm labor and its associated complications.
Documented Applications
Prediction of risk for preterm labor and/or preterm birth in pregnant subjects using biomarker detection in plasma or serum samples taken between 8 and 14 weeks of gestation.
Screening tool to identify pregnant women at increased risk of spontaneous preterm labor to inform early intervention decisions.
Use of specified protein biomarker panels (including CAMK2A, CAMK2B, CAMK2D, BMP-1, and angiostatin) in diagnostic assays and kits for prenatal screening.
Administration of treatments such as antenatal corticosteroids, antibiotics, tocolytics, progesterone, cerclage, and bed rest following positive risk identification to decrease preterm labor risk.
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