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 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.

An enhanced generation of PCR laboratory tests for diagnosis of infection

Amniotic Fluid Quantitative PCR for Diagnosis of IAI
ProteoGenix is also developing an enhanced quantitative PCR test in amniotic fluid for detection and identification of critical pathogen types for diagnosis of intraamniotic infection.

ProteoGenix amniotic fluid quantitative PCR test will identify the presence or absence of two pathogen groups: Gram-positive bacteria and Gram-negative bacteria and four pathogenic organisms: Mycoplasma hominis, Ureaplasma urealyticum Ureaplasma parvum and Candida albicans. ProteoGenix anticipates making this test available through the CLIA certified ProteoGenix Clinical Laboratory in the fourth quarter of 2009.

Pyrosequencing -- a sophisticated nucleic acid base molecular diagnostic technology that allows for quick, accurate and specific identification of individual bacteria and fungi at the species level.

ProteoGenix is using breakthrough Pyrosequencing technology to quickly, accurately and specifically identify a host of potential pathogenic microbes down to the species level. Pyrosequencing allows for this simultaneous identification of multiple microbial gene sequences using DNA sequencing technology consisting of an enzyme-cascade system of four enzymes and specific substrates. Also known as “sequencing by synthesis”, Pyrosequencing produces light in the reaction whenever a nucleotide is incorporated as a base pair with the complementary base in a DNA template strand. Pyrosequencing is a rapid process allowing the sequencing of 30 to 40 base pairs in less than an hour.