Abstract: A system of diagnostic test methods are provided for diagnosing whether a primary breast tumor from an individual human subject is a clinically metastatic tumor. These in-vitro diagnostic methods detect and utilize the presence or absence of a 55 kilodalton protein for the DNA or the RNA coding for an expressing this protein as a marker and indicator of tumor metastasis. The test methods thus can detect either the presence of the protein itself, or its unique DNA, or its singular RNA individually or collectively. Each method of detection provides a reliable indicator and marker by which to clinically diagnose and determine if a primary tumor within the breast of a living human subject is now or will soon likely be a metastatic tumor.

Abstract: A system of diagnostic test methods are provided for diagnosing whether a primary breast tumor from an individual human subject is a clinically metastatic tumor. These in-vitro diagnostic methods detect and utilize the presence or absence of a 55 kilodalton protein for the DNA or the RNA coding for an expressing this protein as a marker and indicator of tumor metastasis. The test methods thus can detect either the presence of the protein itself, or its unique DNA, or its singular RNA individually or collectively. Each method of detection provides a reliable indicator and marker by which to clinically diagnose and determine if a primary tumor within the breast of a living human subject is now or will soon likely be a metastatic tumor.

Abstract: A unique monoclonal antibody is provided for determining the functional status of human estrogen receptor protein. The monoclonal antibody will specifically bind and react with an epitope present within the transactivation function, A/B domain of the human estrogen receptor protein. The functional status of the A/B domain is determined by identifying and discriminating among the 8S, 4S, 5S isoforms of the A/B region as these exist in the human estrogen receptor protein.

Abstract: The present invention provides unique prepared immunogens, site-specific polyclonal antisera and monoclonal antibodies against the DNA-binding domain of estrogen receptor protein, and immunoassay to determine the functional status of estrogen receptors in a cellular sample. Collectively or individually the component parts of the invention provide the ability not only to identify accurately the presence of human estrogen receptor but also the capability of determining whether the estrogen receptor exists in a functional or non-functional state.

Abstract: The present invention provides unique prepared immunogens, site-specific polyclonal antisera and monoclonal antibodies against the DNA-binding domain of estrogen receptor protein, and immunoassay to determine the functional status of estrogen receptors in a cellular sample. Collectively or individually the component parts of the invention provide the ability not only to identify accurately the presence of human estrogen receptor but also the capability of determining whether the estrogen receptor exists in a functional or non-functional state.