The long term goal of this project is to develop pregnancy diagnostic tests based on molecules produced by the placenta. One such candidate molecule is HLA-G, an unusual major histocompatibility complex class I protein. During Phase I of this project the investigators found that HLA-G is easily detectable, by immunoblotting, in amniotic fluid. This suggests that HLA-G measurements could be used in diagnostic assays that detect amniotic fluid analytes. In support of this hypothesis, the preliminary data suggest that a HLA-G immunoassay of cervicovaginal fluid could diagnose rupture of fetal membranes (ROM). Because Adeza has shown that a ROM test that detects fetal fibronectin (fFN) in amniotic fluid can also predict impending preterm delivery (PTD), the investigators are interested in the possibility that an HLA-G immunoassay can be adapted for this purpose. Accordingly, in this Phase II application, the investigator proposes to: 1. Construct HLA-G immunodiagnostic assays (immunochromatographic/ dipstick and ELISA formats) analogous to Adeza's existing technologies used to detect fFN in cervicovaginal fluid. 2. Determine if HLA-G levels in cervicovaginal fluid are indicative of ROM, and possibly of impending PTD. At the conclusion of the proposed Phase II experiments, the investigator will have identified a clinical use for an HLA-G immunoassay, thus rapidly proceeding to Phase III-commercialization and marketing of this test.

Proposed Commercial Applications

NOT AVAILABLE

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Small Business Technology Transfer (STTR) Grants - Phase II (R42)
Project #
2R42DA011103-02
Application #
2644746
Study Section
Special Emphasis Panel (ZRG2-REN (02))
Project Start
1996-09-30
Project End
2000-07-31
Budget Start
1998-09-01
Budget End
1999-07-31
Support Year
2
Fiscal Year
1998
Total Cost
Indirect Cost
Name
Adeza Biomedical Corporation
Department
Type
DUNS #
City
Sunnyvale
State
CA
Country
United States
Zip Code
94089