From the beginning, forward thinking by ProteoGenix’ founders established a key differentiating factor from other start-up diagnostic companies. Access to specimens was identified as a critical element needed to develop quality pregnancy-related tests. Utilizing a large network of existing relationships and forging some new ones, ProteoGenix was able to establish access to significant amounts of specimens through specimen banks and its own clinical trial sites.

ProteoGenix’ unique access to specimens is illustrated by its current prospective multi-center trial on intraamniotic infection (IAI), which is one of the largest and most comprehensive trials of its kind. To date, this ProteoGenix trial is the only one of its kind to rigorously collect comprehensive sets of specimens from:

• maternal serum

• amniotic fluid

• cervical vaginal fluid

• umbilical cord blood

Through the fourth quarter of 2009 approximately 20 clinical sites are participating in the ProteoGenix intraamniotic infection specimen banking trial. These sites are affiliated with some of the most prestigious Maternal-Fetal Medicine groups and research hospitals in the United States. Patient enrollment is actively underway at all trial sites and ProteoGenix is working closely with FDA to collect to the required quantity and quality of specimens needed to support a Pre-Marketing Approval (PMA) submission for the ProteoGenix Cervical-Vaginal fluid intraamniotic infection Invitro Diagnostic kit.

Prior to the ProteoGenix IAI trial, researchers have struggled with the difficulty involved in collecting specimens in this complex field. Overcoming the intricacy of execution, ProteoGenix is able to gather the specimens needed to complete the important discovery work required to identify the appropriate biomarkers for some of the most confounding and serious complications of pregnancy.