Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving virus or bacteriophage
Patent
1989-08-25
1998-07-21
Arthur, Lisa B.
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving virus or bacteriophage
435 912, 435 6, 536 2432, 536 2433, C12Q 168, C12Q 170, C12P 1934, C07H 2104
Patent
active
057834121
DESCRIPTION:
BRIEF SUMMARY
TECHNICAL FIELD OF INVENTION
This invention relates to a method for the specific detection of the DNA of papillomaviruses in clinical samples. In particular, the test aims to differentiate, in the shortest possible time, whether cells from the anogenital region contain types of papillomavirus that are associated with cancer or whether they contain types of papillomavirus that are generally associated with benign lesions. Such differentiation has important implications in patient evaluation and follow-up.
BACKGROUND
Cancer of the cervix is the most common cancer in women (.about.25% of all female cancer). Moreover, the incidence is increasing in younger women. Indeed, approximately 2% of routine cervical smears show abnormal cytology, indicating an epidemic. Such an epidemic is current in many western and developing countries. Sexual activity appears to be an important predisposing factor in the epidemiology of carcinogenesis and precancerous lesions. An early age of sexual intercourse and multiplicity of sexual partners are associated statistically with an increased risk of are often men with penile warts ("high risk males"), and a very high proportion (>90%) of cervical carconoma tissue contain detectable DNA sequences for known varieties of the human papillomavirus (HPV). This supports a growing body of evidence implicating certain types of HPV as the sexually transmitted factor involved in the development of Med.Virol. 30: 170-86, 1984; zur Hausen, Progr. Med.Virol. 32: 15-21, 1985; zur Hausen, Cancer 59: 1692-6; Campion et al., Lancet i: 943-6, 1985!. The prevalence of cervical cancer and precancerous lesions is becoming increasingly more common in younger women. Without treatment it can be fatal, the death rate being .about.100 per million women per year in Western countries. Fortunately, if detected at an early stage, effective treatment is available that can eliminate the fatal consequences.
The immediate management and subsequent follow-up young women with abnormal cytological smears who still wish to bear children presents many problems. This has been compounded by uncertainty about the interpretation of smears with features of papillomavirus infection ("kilocytes") as well as dysplasia. Moreover, the current cytological testing tool for cervical cancer screening, the Pap smear, has a false negative rate of .about.20%. Significant numbers of dysplastic lesions regress spontaneously, others fail to progress, while a few progress rapidly. Thus, from an ill-defined cloud of morphological abnormalities occasional cancers develop. At present there is no clear way to predict whether cancer will result if a Pap smear happens to be abnormal. Clinical examination of many of these patietns has failed to find warty lesions (condylomata accuminata) on the external genitalia or, indeed, on the cervix itself. The more difficult procedure of colposcopy, after the application of 3% acetic acid, is, in fact, required, revealing the presence of flat ("non-condylomatous") warts (which are invisible to the naked eye). These articles suspected premalignant lesions. Histopathological progression of the wart to Dyson et al., J. Clin. Path. 37: 126-31, 1984!. An increasingly prevalent problem is the occurrence of invasive cancer within 3 years of a negative Med. J. Aust. 2: 597, 1981!. Whereas the presence of papillomavirus replication may be confirmed in cervical condylomata by detection of virus particles or the group-specific antigen, neither particles nor antigen have, however, been found in squamous cell carcinoma tissue.
In contrast to the uncertainty and controversy that surrounds the interpretation of tests based on morphology, the new techniques in molecular biology can be utilised by bypass such problems and provide more objective information. By using nucleic acid hybridization techniques the viral DNA can be identified directly and at an earlier stage of infection. Indeed, using these approaches, HPV types have been found in both benign and premalignant lesions.
At present .about.50 types of the papill
REFERENCES:
patent: 4683195 (1987-07-01), Mullis
patent: 4683202 (1987-07-01), Mullis
patent: 5176995 (1993-01-01), Sninsky
patent: 5364758 (1994-11-01), Meijer
Griffin N.R. et al 1990 "Demonstration of multiple . . . " J. Clin. Pathology.
Morris B.J. et al 1990 Automated polymerase chain reaction . . . J. Med Virol 31.
Saiki, R.K. et al 1986 "Analysis of enzymatically amplified . . . " Nature 324 (6093) 163-166.
Young LS., et al 1989 "The Polymerase Chain vaction" Brit. Med. J.29814-18.
Schwarz E., et al 1983 "DNA Sequence . . . " EMBO J. 21 (12) 2341-2348.
Seidorf et al 1985, "Human papillomauvirus . . . " Virol 145: 181-185.
Shibata, DK et al 1988 "Detection of human populoma . . . " J. Exp. Med. 167: 225-230.
Boshart, M. et al., "A new type of Papillomavirus DNA, its presence in genital cancer biopsies and in cell lines derived from cervical cancer" The EMBO Journal vol. 30 No. 5 pp. 1151-1157, 1984.
Chow, V.T.K., et al., "Thermus aquaticus DNA polymerase-catalysed chain reaction for the detection of human papillomaviruses" Journal of Virological Methods, 27 (1990) 101-112.
Chow, V., et al., "Molecular diagnosis of genital HPV DNA types by polymerase chain reaction and sensitivity-standarized filter in situ hybridization in randomly sample cohorts of Singapore woman" Molecular and Cellular Probes (1990) 4, 121-131.
Claas, C.J.E., et al., "Human Papillomarvirus Detection in Paraffin-Embedded Cervical Carcinomas and Metastases of the Carcinomas by the Polymerase Chain Reaction" American Journal of Pathology, vol. 135, No. 4, Oct. 1989.
Cornelissen, M.T.E., et al., "Localization of Human Papillovarvis Type 16 DNA Using the Polymerase Chain Reaction in the Cervix Uteri of Women with Cervical Intraepithelial Neoplasia" J. gen. Viro. (1989) 70, 2555-2562.
Dallas, P.B., et al., "Polymerase Chain Reaction for Fast, Nonradioactive Detection of High-and Low-Risk Papillomavirus Types in Routine Cervical Specimens and in Biopsies" Journal of Medical Virology 27:105-111 (1989).
Dartmann, K., et al "The Nucleotide Sequence and Genome Organization of Human Papilloma Virus Type 11" Virology 151, 124-130 (1986).
Day, P.J.R., et al., "Synsthesis in vitro and application of oiotinylated DNA probes for human papilloma virus type 16 by utilizing the polymerase chain reaction" Biochem. J. (1990) 267, 119-123.
Durst, M., et al., "A papillomavirus DNA from a cervical carcinoma and its prevalence in cancer biopsy samples from different geographic regions" Proc. Natl. Acad. Sci. USA vol. 80 pp. 3812-3815, Jun. 1983 Medical Sciences.
Gregoire, L., et al., "Amplification of Human Papillomavirus DNA Sequences by Using Conserved Primers" Journal of Clinical Microbiology, De. 1989, pp. 2660-2665.
Harju, L., et al., "Affinity-based collection of amplified viral DNA: application to the detection of human immunodeficiency virus type 1 human cytomegalovirus and human papillomavirus type 16" Molecular and Cellular Probes (1990) 4, 223-235.
Matlashewski, G., et al., "The Express of Human Papillomavirus Type 18 E6 Protein in Bacteria and the Production of Anti-E6 Antibodies" J. gen. Viro (1986), 67, 1909-1916.
McNicol, P.J., et al., "Detection of Human Papillomavirus DNA in Prostate Gland Tissue by Using the Polymerase Chain Reaction Amplification Assay" Journal of Clinical Microbiology, Mar. 1990 pp. 409-412.
Meanwell, C.A., "The epidemiology of human papillomavirus infection in relation to cervical cancer" Cancer Surveys, vol. 7, No. 3, 1988 pp. 486-487.
Melchers, W.J.G., et al., "Human Papillomavirus Detection in Urine Samples from Male Patients by the Polymerase Chain Reaction" Journal of Clinical Microbiology, Aug. 1989, pp. 1711-1714.
Roman, A., et al., "Human Papillomaviruses: Are We Ready to Type?" Clinical Microbiology Reviews, Apr. 1989, pp. 166, 176, 177.
Saiki, R.K., et al., "Enzymatic Amplification of -Globin Genomic Sequences and Restriction Site Analysis for Diagnosis of Sickle Cell Anemia" Science, vol. 230, 1985, pp. 1350-1354.
Scharf, S.J., et al., "Direct Cloning and Seq
Morris Brian James
Nightingale Brian
Arthur Lisa B.
Biosearch International Pty. Ltd.
LandOfFree
Method of detection of carcinogenic human papillomavirus does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Method of detection of carcinogenic human papillomavirus, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Method of detection of carcinogenic human papillomavirus will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-1646036