ME-5, ME-2, and EPP2: human protein antigens reactive with autoantibodies present in the serum of women suffering from endometriosis

Abstract

Three human endometrial antigens, ME-5, ME-2 and EPP2, and combination thereof have been discovered that are the targets of antibodies present in the serum of women suffering from endometriosis. These protein products and the human antibodies reactive with them are used as tools for diagnostic assays that monitor patients with the disease of endometriosis.

Description

BACKGROUND OF THE INVENTION [0001] Endometriosis is a female reproductive disorder characterized by the presence of endometrial tissue outside of the normal uterine location. Most frequently the endometriosis tissue is present in the peritoneal cavity, attaching to various tissues and organs in this location. Endometriosis is a benign disease affecting approximately 5 million women in the United States annually with a prevalence of 10 to 15 percent in women of childbearing age. The incidence increases to 60 to 80 percent of women who are infertile or present with pelvic pain (D. Gosselin et al. [1999] Curr. Opin. Onco. Endo. & Metabol. Invest. Drugs 1:31). The conditions that predispose an individual to endometriosis are still unknown. Several authoritative reports suggest that retrograde menstruation may be a key-contributing factor, but this process is thought to be common in most women. This theory has also been questioned recently (D. B. Redwine [2002] Fert. Steril. 78:686) due ...

AI Technical Summary

Benefits of technology

[0061] In initiating a program to identify antigens that may be useful markers of endometriosis (and thus helpful in monitoring women that suffer the disorder) some assumptions were made regarding this disease. First, as noted above, it was assumed that immune system defects occur in these women which enable them to make antibodies directed towards specific endometrial antigens. Second these serum antibodies could be used as tools to identify the antigens, and these proteins in part would form the foundation of immunodiagnostic test systems for monitoring patients with the disorder. The strategy for identification of endometriosis markers was to use patient serum to immunoscreen an endometrial tissue cDNA expression library. Candidate clones would be completely characterized for development of an immunoassay suitable for monitoring patients in a clinical environment.

Problems solved by technology

Although not life threatening, endometriosis results in substantial abdominal discomfort, and may cause infertility.

In fact, such symptoms can be indicative of other feminine health disorders and this makes the diagnosis of endometriosis clinically challenging.

Obviously such delays coupled with the symptoms reported lead to the expenditure of considerable economic and psychological resources.

Some opinions reveal potential hazards with the procedure, and frequently laproscopy does not result in a definitive diagnosis of the disease (S. Pillai et al.

For example, while laproscopy is not classed as major surgery it still has several features (invasive, expensive, requires anesthesia, and full operating facilities) which together make the process an unfortunate choice for diagnosis at least.

In fact, while endometriosis is not fatal disorder, laproscopy itself can be life threatening.

The marker exhibited good specificity, but the sensitivity is poor with high levels present in patients afflicted with PID, ovarian cancer, or cervical carcinoma.

Overall despite the substantial effort extended by numerous researchers, and also as reported in the publications reviewed above, no truly acceptable marker for endometriosis has been discovered.

Yet, the physical and economic impact of the disease, and the difficulty in diagnosing the disorder dictate that the search for suitable markers be continued.

This technology ignores the functional activity of the proteins encoded by the mRNAs, and does not interrogate specimens based on disease hallmarks, symptoms, or the body's response to the illness.

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