Intraamniotic Infection (IAI)
Intraamniotic infection (IAI) is a serious infection of the amniotic fluid and surrounding fetal membranes. These infections may be dangerous to both mother and infant and dramatically increase the risk of infant mortality and serious complications such as neonatal sepsis and cerebral palsy.

Recently, IAI has been identified as a major cause of preterm birth, accounting for approximately 50% of preterm deliveries before 30 weeks, and is also associated with 20 to 40% of cases of early neonatal sepsis and pneumonia.^4,5

There are a number of factors that hinder effective, routine diagnosis of IAI: ~90% of all IAI has no symptoms and therefore is frequently undiagnosed. In addition, the current definitive diagnostic test for IAI is amniocentesis, an invasive procedure that requires up to 48 hours for culture results and is typically unable to detect infections caused by Mycoplasma species, a common IAI pathogen.

ProteoGenix is developing a minimally invasive, cervical-vaginal swab diagnostic test for IAI that will provide results which are faster, more accurate, and more comprehensive than those from amniocentesis.

Neonatal Sepsis
Neonatal sepsis is a serious blood infection of the newborn and is one of the most frequent causes of infant death. It is estimated between 4,200 and 21,000 neonates per year in the U.S. are diagnosed with neonatal sepsis.²¹ However due to limitations with currently available diagnostic tools, evaluation and treatment of “presumed” neonatal sepsis is performed much more broadly.

Neonatal sepsis is the most common diagnostic work-up done in the neonatal intensive care unit (NICU); it is estimated as many as 600,000 U.S. infants per year experience at least 1 evaluation for suspected neonatal sepsis during the birth hospitalization.¹⁴ Furthermore, 130,000 to 400,000 infants per year are treated for “presumed” neonatal sepsis without a definitive diagnosis because diagnostic test results were inconclusive or not available quickly enough. Evaluation and treatment of presumed neonatal sepsis is typically handled in a NICU setting where average cost per day can range from $1,000-$2,500.¹⁵

ProteoGenix is developing non-invasive diagnostics that can help neonatologists rule out neonatal sepsis quickly and efficiently.

Preeclampsia
Preeclampsia consists of elevated blood pressure, proteinuria and edema during pregnancy. Often referred to as ‘pregnancy-induced hypertension’ or ‘toxemia’, preeclampsia can pose a serious risk to both mother and baby. Preeclampsia is present in 5–8% of all pregnancies and a much larger group of expectant mothers is at risk for preeclampsia based on risk factors such as diabetes and obesity. Currently, there is no predictive test to identify expectant mothers most likely to develop preeclampsia.

ProteoGenix’ work on mapping the proteome of pregnancy has poised the company for development of a range of biomarker based predictive and diagnostic tests which will provide information to improve the diagnoses and management of preeclampsia.

Down syndrome
Down syndrome is the most common chromosomal abnormality in humans, affecting almost 1 in 800 babies. Down syndrome occurs when the baby inherits extra genetic material from one parent, causing the physical features and developmental delays that characterize the disorder. It is not known why Down syndrome happens and there is no way to prevent it. One known risk factor is maternal age—women who conceive over the age of 35 are at substantially increased risk. Women over the age of 40 are at even greater risk. ProteoGenix has established a goal of improving Down syndrome screening and diagnosis utilizing novel protein biomarkers we have identified.

Preterm Birth
Preterm birth occurs in 12.8% of the four million births in the United States annually—one of the highest rates of preterm birth in the world—and remains the major obstetrical problem in developed countries. Despite improvements in prenatal care, the rate of preterm birth is climbing—according to the CDC the percentage of preterm births in the United States has increased by over 20% since 1990. ProteoGenix has laid the groundwork for new tests which can help guide physicians in patient management within this critical therapeutic area.