Intra-amniotic Infection

Non-invasive diagnostic test to detect intra-amniotic infection (IAI): This test utilizes a panel of markers, and currently there is no non-invasive test to detect IAI. (See Gravett et al., Proteomic Analysis of Cervical-Vaginal Fluid: Identification of Novel Biomarkers for Detection of Intra-amniotic Infection, Journal of Proteomic Research 6:89-96 and Gravett et al., Diagnosis of intra-amniotic infection by proteomic profiling and identification of novel biomarkers, JAMA 292:462-469). The preclinical validation and prospective clinical study are underway, with patient enrollment in progress. The U.S. market for this product is based on an approximate number of annual pre-term births of 500,000 because all of these births are at risk for IAI.

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