IMMUNODETECTION OF WOMEN AT RISK FOR PRETERM DELIVERY

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$25,750.00
Award Year:
1992
Program:
SBIR
Phase:
Phase I
Contract:
n/a
Agency Tracking Number:
19153
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
Adeza Biomedical Corpon
1240 Elko Dr, Sunnyvale, CA, 94089
Hubzone Owned:
N
Socially and Economically Disadvantaged:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
David C Casal
(408) 745-0975
Business Contact:
() -
Research Institution:
n/a
Abstract
IT IS THE INTENT OF THE INVESTIGATORS TO DEVELOP A NEW DIAGNOSTIC TEST FOR USE DURING PREGNANCY TO IDENTIFY WOMEN AT ELEVATED RISK FOR PRETERM DELIVERY (PTD). AN IMMUNOASSAY USING A MONOCLONAL ANTIBODY DIRECTED AGAINST ONCOFETAL FIBRONECTION (FFN), A PREGNANCY-RELATED PROTEN OF PLACENTAL ORIGIN FOUND IN THE AMNIOTIC FULID, HAS BEEN STANDARDIEZED FOR THIS PURPOSE. PRELIMINARY STUDIES HAVE SHOWN THAT GREATER THAN 50 NG/ML OF FFN WAS PRESENT IN THE CERVICOVAGINAL SECRETIONS OF 81 PERCENT OF WOMEN AT 23 TO 36 WEEKS OF GESTATION WHO SOUGHT MEDICAL ATTENTION FOR SUSPECTED RUPTURE OF MEMBRANES OF PTD, IN CONTRAST TO ONLY 20 PERCENT (P<0.001) OF 267 WOMEN WITH UNCOMPLICATED TERM PREGNANCIES. THIS DIFFERENE COULD NOT BE EXPLAINED BY DIFFERENCES IN GESTATIONAL AGE AT SAMPLING, CERVICAL DILATION OR PRESENCE OF BLOOD IN THE SECRETIONS. THE PRIMARY OBJECTIVE OF PHASE I WILL BE TO CHARACTERIZE THE RELATIONSHIP BETWEEN CERVICOVAGINAL FFN EXPRESSION AND INCIDENCE OF PTD IN A LONGITUDINAL STUDY OF 100 HIGH RISK PREGNANCIES. IN PHASE I, THE INVESTIGATORS WILL DESIGN A PROSPECTIVE CLINICAL TRIAL TO THOROUGHLY EVALUATE THE DIAGNOSTIC EFFICACY OF AN ANTI-FFN ASSAY FOR COMMERCIAL APPLICATION.

* information listed above is at the time of submission.

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