Columbia University

The City University of New York

John F O'Connor

Steven Birken

Galina I Kovalevskaya

Robert E Canfield

Yacov Maydelman

Alexander Krichevsky

The present invention provides a method of predicting pregnancy outcome in a subject by determining the amount of an early pregnancy associated molecular isoform of hCG in a sample. The present invention further provides a method for determining the amount of early pregnancy associated molecular isoforms of human chorionic gonadotropin (hCG) in a sample. The present invention also provides a diagnostic kit for determining the amount of early pregnancy associated hCG in a sample. The present invention additionally provides an antibody which specifically binds to an early pregnancy associated molecular isoform of human chorionic gonadotropin. Finally, the present invention provides methods for detecting trophoblast or non-trophoblast malignancy in a sample.

Methods for predicting pregnancy outcome in a subject by hCG assay

Methods for predicting pregnancy outcome in a subject by HCG assay

Methods for predicting preganancy outcome in a subject by hCG assay

The present invention provides a method for predicting the likely timing of the onset of menopause for a perimenopausal female subject by determining the amount of hLH&#x3b2;cf in a sample from the subject comprising the steps of: (a) contacting a sample from the subject with an antibody which specifically binds to hLH&#x3b2;cf without substantially cross-reacting with hLH, hLH&#x3b2; or hLH&#x3b2;cf, under conditions permitting formation of a complex between the antibody and hLH&#x3b2;cf; (b) measuring the amount of complex formed, so as to thereby determine the amount of hLH&#x3b2;cf in the sample; and (c) comprising the amount of hLH&#x3b2;cf in the subject's sample determined in step (b) with either (i) the amount determined for known postmenopausal female subject or (ii) the amount determined for a sample from a known premenopausal female subject, wherein an amount of hLH&#x3b2;cf in the sample similar to the amount of hLH&#x3b2;cf in the known postmenopausal sample indicates temporal proximity to the onset of menopause, and an amount of hLH&#x3b2;cf in the sample similar to the amount of hLH&#x3b2;cf in the known premenopausal sample indicates temporal distance from the onset of menopause for the subject. AS described herein amount is both concentration and pattern of measurement of concentrations in one or more consecutive urine specimens.

Methods and reagents for determining the amount of hLH&#x3b2; core fragment in a sample

The present invention provides a method of predicting pregnancy outcome in a subject by determining the amount of an early pregnancy associated molecular isoform of hCG in a sample. The present invention further provides a method for determining the amount of early pregnancy associated molecular isoforms of human chorionic gonadotropin (hCG) in a sample. The present invention also provides a diagnostic kit for determining the amount of early pregnancy associated hCG is a sample. The present invention additionally provides an antibody which specifically binds to an early pregnancy associated molecular isoform of human chorionic gonadotropin. Finally, the present invention provides methods for detecting trophoblast or non-trophoblast malignancy in a sample.

Diagnostic kit for predicting pregnancy outcome

The present invention provides methods to quantitate the hLH&#x3b2; core fragment in a sample. The present invention now makes it possible to evaluate the metabolism of hLH in premenopausal, perimenopausal and postmenopausal women and to distinguish between normal and abnormal physiological states.

Diagnostic kit for predicting the onset of menopause

This invention provides an antibody which specifically binds to hLH&#x3b2;cf without cross-reacting with hLH, hLH&#x3b2; or hCG&#x3b2;cf. In an embodiment, the monoclonal antibody is designated B505. In a further embodiment, the hybridoma cell line producing the monoclonal antibody B 505 is designated ATCC Accession No. 12000. This invention provides different uses of the antibodies. Finally, this invention provides a method for determining the amount of hLH&#x3b2;cf or hLH&#x3b2;cf-related molecule in a sample.

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New Rochelle, NY, United States of America

John F O'Connor