Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...
Reexamination Certificate
1999-12-15
2002-04-30
Huff, Sheela (Department: 1642)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving antigen-antibody binding, specific binding protein...
C435S004000, C435S006120, C435S007100, C435S007200, C436S064000, C436S501000, C436S503000
Reexamination Certificate
active
06379907
ABSTRACT:
BACKGROUND OF THE INVENTION
Carcinoma of the cervix is one of the most common malignancies in women, and worldwide it is second only to breast cancer in both incidence and mortality (NIH Consensus Statement (1) Cervical Cancer. 1996.14:1-18). In developed countries in general, and the United States in particular, the wide acceptance of the Pap smear screening program has resulted in dramatic decreases in the incidence of, and mortality from, cervical cancer. However, a recent survey conducted in United States still showed that an estimated 15,700 women were diagnosed with invasive cervical carcinoma, and an estimated 4,900 women died of cervical cancer per annum (NIH Consensus Statement (1) Cervical Cancer. 1996.14:1-18). Moreover, the incidence of adenocarcinorna has tripled in the past two decades (McGonigle K F, and Berek J S. Early stage squamous cell and adenocarcinoma of the cervix. Curr. Opin. Obstet. Gynecol., 1992. 4:109-119), and currently represents up to 25% of all cervical cancers diagnosed (Miller B E, Flax S D, Arheart K, Photopulos G. The presentation of adenocarcinoma of the uterine cervix. Cancer 1993. 72:1281-1285; and Crum C P, Cibas E S, Lee K R. Glandular precursors, adenocarcinomas, and their mimics. In: Pathology of early cervical neoplasia. New York: Churchill Living stone, 1997. 177-240).
Many factors have been implicated in the relatively high incidence of cervical cancer but the inherently high rate of false negatives appears to be one of the major concerns in the current system of screening. The errors have been attributed, in part, to technical problems, but also may well be based primarily on human factors that are not remedied readily by rules and regulations (Kos L G. Cervical (Pap) smear. New directions. Cancer (Phial.), 71 (suppl.); 1993. 1406-1412).
In recent years, the use of new cervical sampling devices (e.g. cytobrushes) have improved the detection of both glandular and squamous neoplasms involving the endocervical canal. However, the increased endocervical cell yields have also created many new patterns of benign and neoplastic endocervical cytology with significant overlapping features. These patterns are unfamiliar to cytologists in routine daily practice. This uncertainty has been reflected in an increase in the cytologic diagnosis of endocervical glandular atypia.
The morphological criteria for a Pap smear diagnosis of AIS and adenocarcinoma have been well described (Ayer B, Pacey F, Greenberg M, Bousfield L. The cytologic diagnosis of adenocarcinoma in situ of the cervix uteri and related lesions. I. Adenocarcinoma in situ. Acta Cytol., 1987. 31:397-411; and Pacey N F. Glandular neoplasms of the uterine cervix. In: Bibbo M, ed. Comprehensive Cytopatholog. Philadelphia: W B Saunders, 1991. 243-255). However, false-negative rates of up to 40 percent in Pap smears from women later found to have AIS and/or invasive endocervical adenocarcinoma have been reported (Crum et al.,1997, 177-240; and Kim H S, Underwood D, Frable W J. Adenocarcinoma in the cervicovaginal Papanicolaou smear: analysis of a 12-year experience. Diagn. Cytopathol., 1991. 7:119-124). The earlier misdiagnosing of AIS/CA was attributed to the presence of low numbers of endocervical glandular cells in the Pap smears, and/or technical artifacts. However, studies have also indicated that human error may play an important role. This includes the incorrect diagnosis of dysplastic glandular cells as exfoliative endometrial cells and/or reactive endocervical cells (Kos et al., 1993; and Lee K R, Manna E A, St. John T. Atypical endocervical glandular cells: accuracy of cytologic diagnosis. Diagn. Cytopathol. 1995. 13:202-208).
In an attempt to clarify the situation, the Bethesda System committee in 1988 established cytologic criteria for atypical glandular cells, and proposed a new diagnostic terminology with a subclassification scheme, in order to aid in patient triage. It was recommended that endocervical glandular abnormalities that exceed reactive change but fall short of invasive adenocarcinoma be reported as atypical glandular cells of undetermined significance (AGUS) (National Cancer Institute Workshop. The revised Bethesda System for reporting cervical/vaginal cytologic diagnosis: report of the 1991 Bethesda Workshop. JAMA, 1992. 267:1892; and Kurman R J, Solomon D. In The Bethesda System for Reporting CervicalNaginal Cytologic Diagnoses. New York: Springer-Verlag, 1994. 64-76). Up to 1.25 million American women receive a diagnosis of AGUS annually (Raab S S, Geisinger K R, Silverman J F, Thomas P A, Stanley M W. Interobserver variability of a Papanicolaou smear diagnosis of atypical glandular cells of undetermined significance. Am. J. Clin. Pathol., 1998. 110:653-659). However, the results of this subclassification have yet to be proven clinically effective.
A broad morphologic spectrum of benign and neoplastic lesions are included in the category of AGUS. These include atypical endocervical repair, endometriosis, microglandular hyperplasia, tubal metaplasia, squamous intraepithelial lesion (SIL) with glandular involvement, and glandular dysplasia, and adenocarcinoma (Lee K R. Atypical glandular cells in cervical smears from women who have undergone cone biopsy. A potential diagnostic pitfall. Acta. Cytol., 1993. 37:705-709; Pacey F, Ayer B, Greenberg M. The cytologic diagnosis of adenocarcinoma in situ of the cervix uteri and related lesions. III. Pitfalls in diagnosis. Acta. Cytol., 1988. 32:325-330; Yahr U, Lee K R. Cytologic findings in microglandular hyperplasia of the cervix. Diagn. Cytopathol. 1991. 7:248-251; Novotny DB, Maygarden S J, Johnson D E, Frable W J. Tubal metaplasia. A frequent potential pitfall in the cytologic diagnosis of endocervical glandular dysplasia on cervical smears. Acta. Cytol., 1992. 36:1-10; Pacey et al., 1991; and Kos L G. Diagnostic cytology and its histopathologic bases. Vol. 1. 4th ed. Philadelphia; J B Lippincott: 1992. 387:452-454).
Several laboratories have conducted follow-up studies in those cases diagnosed as endocervical atypia. The results indicate that approximately 40% of AGUS cases represent high grade SIL, adenocarcinoma in-situ (AIS), or carcinoma, and correspondingly 60% represent benign or insignificant lesions. A surprising range (15-58%) of patients had significant lesions (HSIL, AIS/CA) in follow-up biopsies, after receiving a Pap smear diagnosis of AGUS. Furthermore, only a small fraction of the significant lesions were glandular neoplasms (AIS/CA). Thus, the AGUS diagnosis appears to be a misnomer inasmuch that many AGUS lesions are not glandular at all (Wilbur D C, Mulford D M, Sickel J Z, Atkinson K M. The problem of endocervical atypia: new cytologic presentations of normal endocervical cells. Mod. Pathol., 1994. 38:808; Goff B A., Atanasoff P, Brown E, Muntz H G, Bell D A, Rice L W. Endocervical glandular atypia in Papanicolaou smears. Obstet. Gynecol., 1992. 79:101-104; Lee et al., 1995; Nasu I, Meurer W, Fu Y S. Endocervical glandular atypia and adenocarcinoma: A correlation of cytology and histology., Int. J. Gynecol. Pathol., 1993. 12:208-218; Taylor R, Guerriere J, Nash J D, Henry M R, O'Conner D M. Atypical cervical cytology: Colposcopic follow-up using The Bethesda System, J. Reprod. Med., 1993. 38:443-447; Kennedy A W, Salmieri S S, Wirth S L, Biscotti C V, Tuason L J, Travarca M J. Results of the clinical evaluation of atypical glandular cells of undetermined significance (AGUS) detected on cervical cytology screening. Gynecol. Oncol., 1996. 63:14-18; and Bose S, Kannan V, Kline T S. Abnormal endocervical cells. Really abnormal! Really endocervical! Am. J. Clin. Pathol., 1994. 101:708-713).
There have been many attempts to define cytologic criteria that aid in the diagnosis of glandular lesions of the cervix, with the goal of separating neoplastic glandular cells from reactive changes and squamous neoplasia. Yet, there remains poor agreement among cytopathologists in reclassifying lesions originally diagnosed as AGUS, and in separating clinically significant from benign AGUS lesions
Liao Shu-Yuan
Stanbridge Eric J.
Fulbright & Jaworski L.L.P.
Huff Sheela
Hunt Jennifer
The Regents of the University of California
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