NONINVASIVE IMMUNODETECTION OF ECTOPIC PREGNANCY

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: N/A
Agency Tracking Number: 13747
Amount: $49,000.00
Phase: Phase I
Program: SBIR
Awards Year: 1990
Solicitation Year: N/A
Solicitation Topic Code: N/A
Solicitation Number: N/A
Small Business Information
Aspen Diagnostics Corp
1240 Elko Dr, Sunnyvale, CA, 94089
DUNS: N/A
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 David C Casal
 (408) 745-0975
Business Contact
Phone: () -
Research Institution
N/A
Abstract
THIS PROJECT WILL DEVELOP A NEW DIAGNOSTIC TEST TO SUBSTANTIALLY IMPROVE THE DEFINITIVE DIAGNOSIS OF ECTOPIC PREGNANCY (EP). THIS NEW TEST WOULD COMPLEMENT SERIAL QUANTITATIVE BETA-HCG AND ULTRASOUND TESTING, CURRENTLY USEDFOR DIAGNOSING EP, AND PROVIDE EARLIER AND MORE ACCURATE DIAGNOSIS OF THIS POTENTIALLY FATAL CONDITION. THE NEW TEST IS BASED ON A RECENTLY DISCOVERED MARKER, A UNIQUE PREGNANCY-RELATED PROTEIN (PRP) SECRETED BY THE PROLIFERATIVE TROPHOBLAST DURING THE EARLY STAGES OF PREGNANCY. PRP CAN BE IMMUNOLOGICALLY DETECTED BY A MONOCLONAL ANTIBODY, KNOWN AS A137, DEVELOPED AT ASPEN DIAGNOSTICS CORPORATION. PRP IS PRESENT IN THE CERVICAL MUCOUS OF PREGNANT WOMEN WITH INTRAUTERINE IMPLANTATION BUT APPEARS TO BE ABSENT IN WOMEN WITH EXTRAUTERINE IMPLANTATION. THE ABILITY TO PREDICT THE LOCATION OF A PREGNANCY COULD PROVIDE EARLIER, NONINVASIVE DIAGNOSIS OF EP, BYPASSING COSTLY ULTRASOUND OR INVASIVE DIAGNOSTIC LAPAROSCOPY. FURTHERMORE, RAPID AND ACCURATE DIAGNOSIS AND TREATMENT COULD LOWER THE RATE OF TUBAL RUPTURE, THEREBY LOWERING MORBIDITY AND MORTALITY ASSOCIATED WITH EP. EARLY DIAGNOSIS AND TREATMENT OF EP MAY ALSO IMPROVE FUTURE FERTILITY OF THE AFFECTED PATIENT.

* information listed above is at the time of submission.

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