next generation proteogenix IAI test

As a pioneer in identifying unique proteins associated with advancing maternal, fetal and neonatal diagnosis, ProteoGenix will continue to introduce a new generations of tests.

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

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

The specimen used to conduct this test will be obtained by a simple swab to collect cervical vaginal fluid during a routine speculum exam. This new CVF intraamniotic infection test is based on recent groundbreaking ProteoGenix research that has defined specific proteins in 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 with the “Scientific Presentation Award”.

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 and Ureaplasma sp, organisms commonly associated with IAI which can not be detected by most commonly available lab cultures.

  • 16S rDNA Polymerase Chain Reaction (PCR) detection of microorganisms in amniotic fluid.

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 ProteoGenix CLIA-certified Clinical Laboratory and it is anticipated that results will be available within 24 hours.