Meeting Unmet Needs

ProteoGenix has enjoyed many successes and has consistently introduced ‘industry firsts’ to the category of pregnancy management since its founding in 2002. One of ProteoGenix’ most significant accomplishments is that it is the first company to map the proteome in all the fluids of pregnancy:

• Maternal serum

• Amniotic fluid

• Cervical-vaginal fluid

• Umbilical cord blood

By identifying biomarkers in these key biological fluids associated with pregnancy, proteomic analysis—for the first time—maps out the whole picture for a better assessment of pregnancy-related complications. Prior to this technological and clinical advancement, it was not possible to look at the entire proteome to understand how it changes over the course of pregnancy. ProteoGenix has a created a first-of-a-kind map of how the proteome changes over time and when specific conditions are present.

Proteomic analysis of cervical-vaginal fluid is important because these fluids accurately reflect what is occurring in the maternal reproductive tract due to their proximity to the fetus. In addition, cervical-vaginal fluids are easily accessible via a simple vaginal examination, which is typically routinely conducted during most pregnancies. Finally, the characteristics of cervical-vaginal fluids change over the course of pregnancy to reflect the many changes happening in utero and in the labor process itself.

Amniocentesis is the current method of obtaining a sample of amniotic fluid which is then tested by a range of laboratory procedures to assess conditions such as intraamniotic infection and Down syndrome. Amniocentesis is an invasive procedure that is typically only performed if there is an indication. Potential side effects of amniocentesis include cramping, bleeding and infection as well as a slight increase in the risk of miscarriage. A recent study by the Pregnancy Research Center found several reasons why physicians may be hesitant to perform amniocentesis:

• Some patients decline the amniocentesis procedure because of its invasive nature and the potential risk of associated complications

• Currently available amniotic fluid tests may be limited by relatively low sensitivity and specificity

• The “turnaround time” required to receive test results is too long

ProteoGenix’ discoveries are driven by the desire to provide physicians with better and more meaningful information through innovative diagnostic tests that are highly accurate, minimally invasive, timely and clinically relevant.

ProteoGenix’ work in the areas of intraamniotic infection, neonatal sepsis, preeclampsia, preterm birth and Down syndrome is intended to allow physicians to look at these disease states in ways they’ve never seen before.