

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.