Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...
Patent
1996-07-03
2000-02-15
Achutamurthy, Ponnathapura
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving antigen-antibody binding, specific binding protein...
435 71, 435 793, 436 65, 436501, 436510, G01N 3353, G01N 33537, G01N 33543, G01N 3348
Patent
active
060251492
ABSTRACT:
This invention represents a significant advance in prenatal diagnosis by providing urinary screening to detect fetal aneuploidies. Herein disclosed are methods for prenatally assessing risks of a pregnancy being affected by Down syndrome and other aneuploidies by testing maternal urine samples for levels of .beta.-core-hCG. Levels of maternal urinary .beta.-core-hCG above normal indicate a risk that the pregnancy is affected with Down syndrome, and in general risks of other fetal aneuploidies are indicated by either lower than normal or higher than normal maternal urinary .beta.-core-hCG levels. Assessments can be made based on urinary .beta.-core-hCG levels alone or in conjunction with levels of other urinary and/or serum markers, ultrasound parameters and other factors, such as, maternal age.
REFERENCES:
patent: 4874693 (1989-10-01), Bogart
patent: 5158895 (1992-10-01), Ashihara et al.
patent: 5240912 (1993-08-01), Todaro
patent: 5316953 (1994-05-01), Macri
patent: 5324667 (1994-06-01), Macri
patent: 5356817 (1994-10-01), Cole
patent: 5445968 (1995-08-01), Blithe et al.
Hayashi, et al.: Maternal urinary beta-core fragment . . . : Prenatal Diagnosis: vol. 15: pp. 11-16, Jan. 1995.
Kato, et al.: Beta-Core fragment is a major form of . . . : J. Clin. Endocrin. Metab.: vol. 66, No. 6 : pp. 1197-1201, 1988.
Nicolaides, et al.: Fetal nuchal translucency: ultrasound . . . : Br. Med. J.: vol. 304: pp. 867-869, Apr. 1992.
Kaplan, et al. Clinical Chemistry theory, analysis, and correlation:pp. 691-692 and 1144-1146, 1984.
Canick and Knight, "Multiple-marker Screening for Fetal Down Syndrome," Contemporary OB/GYN, pp. 3-12 (Apr. 1992).
Ciba Corning Diagnostics Corp., "Triton.RTM. UGP EIA Kit" Brochure (May 1995).
Cole, L.A., ".beta.-Core Fragment (.beta.-Core, UGP or UGF)," Tumour Marker Update, 6(3): 69-75 (1994).
Cole et al., "The Deactivation of hCG by Nicking and Dissociation," Journal of Clinical Endocrinology and Metabolism, 76(3): 704-710 (1993).
Cole et al., "Urine hCG .beta.-Subunit Core Fragment, a Sensitive Test for Ectopic Pregnancy," Journal of Clinical Endocrinology and Metabolism, 78(2): 497-499 (1994).
Cuckle, H., "Screening at 11-14 weeks of gestation: the role of established markers and PAPP-A," Screening for Down's Syndrome, Ed. Grudzinskas et al., pp. 311-323 [Cambridge University Press; Cambridge, U.K. (1994)].
Cuckle et al., "Maternal Urine--A Possibility for use in Screening," Screening News (European Down's Syndrome Screening Group Newsletter), 1(2): 5 (Jul. 1994).
Cuckle et al., "Urinary .beta.-Core Human Chorionic Gonadotropin: A New Approach to Down's Syndrome Screening," Prenatal Diagnosis, 14: 953-958 (Oct. 1994).
Hayashi and Kozu, "Maternal Urinary .beta.-core Fragment of hCG/Creatinine Ratios and Fetal Chromosomal Abnormalities in the Second Trimester of Pregnancy," Prenatal Diagnosis, 15: 11-16 (Jan. 1995).
Kato and Braunstein, ".beta.-Core Fragment Is a Major Form of Immunoreactive Urinary Chorionic Gonadotropin in Human Pregnancy," J. Clin. Endocrinol. Metab., 66: 1197-1201 (1988).
Lee et al., "The purification and development of a radioimmunoassay for .beta.-core fragment of human chorionic gonadotrophin in urine: application as a marker of gynaecological cancer in premenopausal and postmenopausal women," J. Endocrinol, 130: 481-489 (1991).
Cole, L. A., "Down syndrome screening using urine .beta.-core fragment test: choice of immunoassay," Prenatal Diagnosis, 15: 679-682 (1995) (letter to the editor).
Kellner et al., "Maternal Urine Screening for Fetal Down Syndrome: Comparison of Beta-Core Fragment, Free-Beta Subunit and HCG," Am. J. Obstet. Gynecol., Society of Prenatal Obstetricians (SPO) 1996 Annual Meeting (Hawaii, Feb. 4-10, 1996).
Spencer et al., "Urine Free Beta hCG and Beta Core in pregnancies affected by Trisomy 21," Am. Soc. Hum. Genet., 57: A289 (Oct. 1995) (Abstract).
O'Connor et al., "Recent Advances in the Chemistry and Immunochemistry of Human Chorionic Gonadotropin: Impact on Clinical Measurements," Endocrine Reviews, 15(5): 650-683 (1994).
Akar, et al., "A Radioimmunoassay for the Core Fragment of the Human Chorionic Gonadotropin .beta.-Subunit," Journal of Clinical Endocinology and Metabolism, 66(3): 538-545 (1988).
O'Connor et al., "Development of Highly Sensitive Immunoassays to Measure Human Chorionic Gonadotropin, Its .beta.-subunit, and .beta. Core Fragment in the Urine: Application to Malignancies," Cancer Research, 48: 1361-1366 (Mar. 1, 1988).
Spencer et al., "Free .beta.-hCG as first-trimester marker for fetal trisomy," The Lancet, 339: 1480 (Jun. 13, 1992).
Chard Timothy
Cuckle Howard S.
Iles Raymond K.
Achutamurthy Ponnathapura
Lauder Leona L.
Nelson Brett
Yale University
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