A new generation of noninvasive cervical vaginal fluid based diagnostic test for amniotic infection in preterm labor that overcome the limitations of currently available IAI diagnostic tools

ProteoGenix is currently developing the first-ever noninvasive diagnostic test utilizing cervical-vaginal fluid (CVF) that is intended to detect the presence of IAI in pregnant patients with intact membranes presenting with preterm labor between 22 to 37 weeks gestation.

The specimen used to conduct this test will be obtained by a simple swab to collect CVF during a routine speculum exam. This new CVF intraamniotic infection test is based on recent groundbreaking ProteoGenix research that has defined the proteome of all the key biological fluids associated with pregnancy, and quantified unique protein biomarkers in CVF that differentiate IAI from non-IAI in PTL patients. This research was recognized by the Society for Maternal-Fetal Medicine in 2007.

The ProteoGenix CVF IAI test is based on a comprehensive definition of IAI that includes:

• Positive amniotic fluid culture for all relevant pathogens, including Mycoplasma sp and Ureaplasma; organisms commonly associated with IAI, which can be difficult to recover with most commonly available lab cultures.

• Polymerase Chain Reaction (PCR) detection of microorganisms in amniotic fluid.

• Amniotic fluid, Gram stain, and glucose concentration.

• Clinical signs and symptoms.

The ProteoGenix cervical vaginal fluid IAI diagnostic test is anticipated to be faster, more accurate and significantly less invasive than current diagnostic tools. These performance advantages of the ProteoGenix CVF IAI diagnostic test will enable broader and more comprehensive diagnosis and treatment of IAI in preterm labor resulting in improved clinical outcomes and reduced healthcare costs as compared to the current standard of care.

The ProteoGenix CVF IAI diagnostic test is anticipated to be commercially available in the United States in the first quarter of 2010. This test will be available via the CLIA-certified ProteoGenix Clinical Laboratory and it is anticipated that results will be available within 24 hours in most cases.