HCG REFERENCE SERVICE
ABOUT LAURENCE A. COLE PH.D.

PERSONAL DATA

Date of Birth: February 8, 1953
Citizenship: U.S.A.

Telephone: (505) 272-6137
E-mail: larry@hcglab.com or lcole@salud.unm.edu

EDUCATION

Ph.D., 1982, Biochemistry, Medical College of Wisconsin
2/82-10/83, University of Michigan, Postdoctoral Fellow, Department of Pharmacology

PROFESSIONAL APPOINTMENTS

10/83®3/86 University of Michigan, Ann Arbor, Michigan

Assistant Research Scientist in Internal Medicine and in the

Reproductive Endocrinology Program

3/86®5/92 Yale University, New Haven, Connecticut

Assistant Professor in Department of Obstetrics & Gynecology.

5/93®10/99 Yale University, New Haven, Connecticut. Associate Professor

in Obstetrics & Gynecology, and in Yale Cancer Center

11/99®present University of New Mexico, Albuquerque, New Mexico

Professor of Obstetrics & Gynecology and Biochemistry & Molecular Biology

Chief, Division of Women’s Health Research

11/99®present Yale University, New Haven, Connecticut. Affiliate Professor

in Obstetrics & Gynecology

PATENTS

US patent hCG free b-subunit and b-core fragment in detecting the onset, progression and regression of gynecologic cancers

US patent Gonadotropin b-subunit nicking enzyme, a marker of early stage malignancies

World patent Prenatal screening for Down syndrome using hyperglycosylated gonadotropin

World patent hCG b-core fragment in the detection of ectopic pregnancy

PRIZES

October 95 Institute for Anticancer Research, symposium “Tumor Markers from Biology to therapy”. Biannual Prize

February 96 American Association for Clinical Chemistry, Outstanding Speaker Award for 1995

April 2000 American Association for Clinical Chemistry, 2000, Most Outstanding Contributor to Clinical Chemistry.

PROFESSIONAL SOCIETY HONORS

since 2001 Secretary and Treasurer, International Society for the Study of Trophoblastic Diseases

BIBLIOGRAPHY

1. Cole, L.A., Hussa, R.O., and Rao, C.V. Discordant synthesis and secretion of human chorionic gonadotropin and subunits by cervical cancer cells. Cancer Res. 41:1615-1619, 1981.

2. Cole, L.A., and Hussa, R.O. Use of glycosidase digested human chorionic gonadotropin ß-subunit to explain the partial binding of glycoprotein hormones to Con A. Endocrinology, 109:2276-2279, 1981.

3. Story, M.T., Cole, L.A., and Hussa, R.O. A procedure using immobilized antibody for the isolation of the ß-subunit of human chorionic gonadotropin from the culture fluids of a ß-subunit-secreting nontrophoblastic cell line. J.Clin.Endocrinol.Metab. 53:1090-1095, 1981.

4. Cole, L.A., Birken, S., Sutphen, S., Hussa, R.O., and Pattillo, R.A. Absence of the COOH-terminal peptide on ectopic human chorionic gonadotropin ß-subunit (HCG-ß). Endocrinology 110:2198-2200, 1982.

5. Cole, L.A., Hartle, R.J., Laferla, J.J., and Ruddon, R.W. Detection of the free ß subunit of human chorionic gonadotropin in cultures of normal and malignant trophoblast cells, pregnancy sera, and sera of patients with choriocarcinoma. Endocrinology 113:1176-1178, 1983.

6. Pattillo, R.A., Hussa, R.O., Cole, L.A., and Yorde, D.E. Hormone synthesis by normal and neoplastic trophoblast. In: Biology of Trophoblast (eds: Loke and Whyte), Elsevier Science, pp. 283-316, 1983.

7. Cole, L.A., Kroll, T.G., Ruddon, R.W., and Hussa, R.O. Differential occurrence of free ß and free alpha subunits of human chorionic gonadotropin (hCG). J.Clin.Endocrinol.Metab. 58:1200-1202, 1984.

8. Cole, L.A., and Hussa, R.O. The carbohydrate on human chorionic gonadotropin produced by cancer cells. Adv.Exper.Med.Biol.176:245-270,1984.

9. Cole, L.A., Perini, F., Birken, S., and Ruddon, R.W. An oligosaccharide of the O-linked type distinguishes the free from the combined form of hCG alpha-subunit. Biochem.Biophys.Res.Comm. 122:1260-1267, 1984.

10. Hussa, R.O., and Cole, L.A. New horizons in clinical hCG detection. Adv.Exper.Med.Biol. 176:217-244, 1984.

11. Nagelburg, S.B., Cole, L.A., and Rosen, S.W. A novel form of the free ß-subunit of chorionic gonadotropin in the serum of a woman with epidermoid carcinoma. J.Endocrinol. 107:403-408, 1985.

12. Cole, L.A., Birken, S., and Perini, F. The structures of the serine-linked sugar chains on human chorionic gonadotropin. Biochem.Biophys.Res.Comm. 126:333-339, 1985.

13. Cole, L.A., Scheid, J.M., and Tannen, R.L. Induction of mitochondrial metabolism and pH-modulated ammoniagenesis in LLC-PK1 cells. Am.J.Physiol., 251 (Cell Physiology 20) C293-C298, 1986

14. Castor, C.W., Cabral, A.R., Cole, L.A., Walz, D.A., Hossler, P.A., Bignall, M.C., Furlong, M.A., and Smith, E.M. Regulation of synovial cell metabolism by growth factors. Rheumatology-85 (eds. Brooks and York), Elsevier pp. 73-76, 1986.

15. Hussa, R.O., Fein, H.G., Pattillo, R.A., Nagelberg, S.B., Rosen, S.W., Weintraub, B.D., Perini, F., Ruddon, R.W., and Cole, L.A. A distinctive form of human chorionic gonadotropin ß-subunit -like material produced by cervical carcinoma cells. Cancer Res. 46, 1948-1954, 1986.

16. Cole, L.A., Restrepo-Candelo, H., Lavy, G., and DeCherney, A. hCG free ß-subunit an early marker of outcome of in vitro fertilization clinical pregnancies. J.Clin.Endocrinol.Metab., 64:1328-1330, 1987.

17. Cole, L.A. O-Glycosylation of proteins in the normal and neoplastic trophoblast. Troph.Res., 2:139-148, 1987.

18. Grotjan, H.E., and Cole, L.A. Ovine and human luteinizing hormone deglygosylated with endoglycosidase F. Ann. N.Y.Acad.Sci. 513:329-331, 1987.

19. Imamura, S., Armstrong, G.A., Birken, S., Cole, L.A., and Canfield, R.E. Highly specific and sensitive measurements of desialylated forms of human chorionic gonadotropin with lectin immunoradiometric assays. Clin.Chimica Acta, 163:339-349, 1987.

20. Cole, L.A. Distribution of O-linked sugar units on hCG and its free alpha-subunit. Mol.Cellular Endocrinol., 50:45-57, 1987.

21. Cole, L.A., Metsch, L. and Grotjan, H.E. Significant steroidogenic activity of luteinizing hormone is maintained after enzymatic removal of oligosaccharides. Molec.Endocrinol., 1:621-627, 1987.

22. Cole, L.A. The O-linked oligosaccharides are strikingly different on pregnancy and choriocarcinoma hCG. J.Clin.Endocrinol.Metab., 65:811-813, 1987

23. Cabral, A.R., Cole,L.A., Walz, D.A., and Castor, C.W. Connective tissue activation. XXXII. Structural and biologic characteristics of mesenchymal cell-derived connective tissue activating peptide-V. Arthritis Rheum., 30:1393-400, 1987

24. Restrepo-Candelo, H., Lavy, G., Thatcher, S.S., DeCherney, A.H., and Cole, L.A. Free ß-subunit of human chorionic gonadotropin measurements in in vitro fertilization pregnancies. prediction of outcome, Rev. Latinoamer. Steril. Fertil. 1:142-146, 198

25. Birken, S., Agosto, G., Amr, S., Nisula, B., Cole, L., Lewis, J., and Canfield, R.E. Characterization of antisera distinguishing carbohydrate structures in the ß carboxyl-terminal region of human chorionic gonadotropin. Endocrinology, 122:2054-2063, 1988

26. Cole, L.A., Wong, Y., Latif, M., Chambers, J.T., Chambers, S.K. and Schwartz, P.E. Urinary human chorionic gonadotropin free ß-subunit and ß-fragment: new markers gynecologic cancers. Cancer Res., 48:1356-1360, 1988

27. Birken, S., Armstrong, E.G., Kolks, M.A.G., Cole, L.A., Agosto, G.M., Krichevsky, A., and Canfield, R.E. The structure of the human chorionic gonadotropin ß-subunit core fragment from pregnancy urine. Endocrinology, 123:572-583, 1988

28. Cole, L.A. Occurrence and properties of glycoprotein hormone free subunits. In: Microheterogeneity of Glycoprotein Hormones (eds. Grotjan and Keel), CRC,pp. 53-74, 1988.

29. Cole, L.A. Hormones and Reproduction, Yale-New Haven Teachers Institute, Volume 5, pp 1-168, 198

30. Grotjan, H.E., and Cole, L.A. hCG microheterogeneity. In: Microheterogeneity of Glycoprotein Hormones (eds. Grotjan and Keel), CRC, pp. 219-237, 1988.

31. Cole, L.A., Schwartz, P.E., and Wong, Y. Urinary gonadotropin fragments (UGF) in cancers of the female reproductive system: I. Sensitivity and specificity, comparison with other markers. Gyn.Onc., 31:82-90, 1988

32. Wong, Y., Schwartz, P.E., Chambers J.T., and Cole, L.A. Urinary gonadotropin fragments (UGF) in cancers of the female reproductive system: II. Initial serial studies. Gyn.Onc., 31:91-100, 1988

33. Cole, L.A., and Birken, S. Origin and Occurrence of human chorionic gonadotropin ß-subunit core fragment. Molec.Endocrinol., 2:825-830, 1988

34. Cole, L.A., and Wang, Y. Use of intact human chorionic gonadotropin and its free alpha- and ß-subunit in the detection and management of gynecologic cancers. Ch. J. Medicine., 68:101-103, 1988.

35. Sahai, A., Cole, L.A., Clarke, D.L., and Tannen, R.L. Rocking promotes cellular differentiated properties in cultured cells by improved oxygenation. Am.J.Physiol., 256:C1064-C1069, 1989

36. Cole, L.A., and Nam, J.H. Urinary gonadotropin fragment measurements in the diagnosis and management of ovarian cancer. Yale J. Med. Bio., 62:367-378, 1989.

37. Sahai, A., Cole, L. A., and Tannen, R.L. Pathways of regulation of metabolism by LLC-PK1 cells in culture. J.Lab.Clin.Med., 114:285-293, 1989

38. Nam, J.H., Cole, L.A., Chambers, J.T., and Schwartz, P.E. Urinary gonadotropin fragment, a new tumor marker: I. Assay development and cancer-specificity. Gynecol. Oncol., 36:383-390, 1990

39. Cole, L.A., Nam, J.H., Chang, K.C., Chambers, J.T., and Schwartz, P.E. Urinary gonadotropin fragment, a new tumor marker: II. For differentiating a benign from a malignant pelvic mass. Gynecol. Oncol., 36:391-394, 1990

40. Nam, J.H., Chang, K.C., Chambers, J.T., Schwartz, P.E., and Cole, L.A. Urinary gonadotropin fragment, a new tumor marker: III. Use in cervical and vulvar cancers. Gynecol. Oncol., 38:66-70, 1990

41. Cole, L.A., Kardana, A., and Birken, S. The isomers, subunits and fragments of hCG. Serono Symposia, 65:59-80, 1990

42. McGill J., Cole, L.A. Nam, J., Thornson, A., Christensen, M., Mailliard, J., Chun, M., Wilwerding, M., Nam, J., and Boman, B. Urinary gonadotropin fragment (UGF): A potential "marker" of colorectal cancer, J. Tumor Marker Oncol. 5:175-177, 1990

43. Cole L.A. Human chorionic gonadotropin production in early and 6-40 week pregnancies, and in women with choriocarcinoma. J. Cancer Res. Clin. Onc. 116:1127, 1990.

44. Nam, J.H., Chambers, J.T., Schwartz, P.E., and Cole, L.A. Urinary gonadotropin fragment, a new tumor marker: IV. Use in endometrial and uterine cancers. Gynecol. Oncol. 39:353-357, 1990.

45. Kardana, A., and Cole, L. A. Serum hCG ß-core fragment is masked by associated macromolecules. J. Clin. Endocrinol. Metab. 71:1393-1395, 1990

46. Castor, C.W., Waltz, D.A., Johnson, P.H., Hossler, P.A., Smith, E.M., Bignall, M.C., Aaron, B.P., Underhill, P., Lazar, J.M., Hudson, D.H., Cole, L.A., Perini, F., and Mountjoy, K. Connective tissue activation XXXIV: effects of proteolytic processing on the biologic activities of CTAP-III. J. Lab. Clin. Med. 116:516-526, 1990.

47. Knight G.J., and Cole, L.A., Free ß-subunit hCG measurements: An alternative to hCG for fetal Down Syndrome screening? Clin. Chem. 37:779-782, 1991.

48. Cole L.A., Kardana, A., Andrade-Gordon, P., Gawinowicz, M.A., Morris, J.C., Bergert, E.R., O'Connor, J., and Birken, S. The Heterogeneity of hCG: III. The occurrence, biological and immunological activities of nicked hCG. Endocrinology 129:1559-1567, 1991.

49. Kardana, A., Elliott, M.E., Gawinowicz, M.A., Birken, S., and Cole, L.A. The heterogeneity of hCG: I. Characterization of peptide variations in 13 individual preparations of hCG. Endocrinology 129:1541-1550, 1991.

50. Birken, S., Gawinowicz, M.A., Kardana, A., and Cole, L.A. The Heterogeneity of hCG: II. Characteristics and origins of nicks in hCG reference standards. Endocrinology 129:1551-1558, 1991.

51. Kardana, A., and Cole, L.A. Polypeptide Nicks Cause Erroneous Results in Human Chorionic Gonadotropin Free ß-subunit Assays. Clin. Chem., 38:26-33,1992

52. Rotmensch, S., Liberati, M., Kardana, A., Copel, J.A., Ben-Rafael, Z., Cole, L.A. (1996). Nicked free b-subunit of human chorionic gonadotropin: A potential new marker for Down syndrome screening. Am J Obstet Gynecol 174, 609-611.

53. Cole, L.A., and Kardana, A. Discordant Results in human chorionic gonadotropin assays. Clin. Chem., 38:263-270, 1992

54. Schwartz, P.E., Chambers, J.T., Pellerito, J., Hammers, L., Cole, L.A., Yang-Feng, T., Smith, P., Mayne, S., and Makuch, R. Early detection of ovarian cancer: Background,rationale and structure of the Yale early detection program. Yale J. Biol. Med., 64:557-571, 1991.

55. Cole, L.A., and Kardana, A. The biological and clinical significance of nicks in human chorionic gonadotropin and its free ß-subunit. Yale J. Bio. Med., 64:627-627, 1991.

56. Schwartz, P.E., Chambers, J.T., Taylor, K., Pellerito, J., Hammers, L., Cole, L.A., Yang-Feng, T., Smith, P., Mayne, S., and Makuch, R. Early detection of ovarian cancer: Preliminary results of the Yale Early Detection Program. Yale J. Biol. Med., 64:573-582, 1991.

57. D'Agostino, R.S., Cole, L.A., Ponn, R.B., Stern, H., Schwartz, P.E. Urinary gonadotropin fragment in patients with lung and esophageal disease. J. Surg. Oncol. 49:147-150, 1992.

58. Merz, W.E., Kardana, A., Cole, L.A. Formation of a hCG variant with truncated peptide moiety as a biosynthetic product in vitro. Troph. Res., 7: 1993

59. Cole, L.A., Kardana, A., Park S-Y., Braunstein, G. The deactivation of hCG by nicking and dissociation. J. Clin. Endocrinol. Metab., 76:704-710, 1993

60. Cole, L.A., Seifer, D.B., Kardana, A., Braunstein, G.D. Selecting human chorionic gonadotropin immunoassays: Consideration of crossreacting molecules in first trimester pregnancy serum and urine. Am. J. Obstet. Gynecol., 168:1580-1586, 1993

61. Bohler, H., and Cole, L.A. Human chorionic gonadotropin and related molecules in pregnancy serum and urine. Assisted Reprod. Rev., 3:48-48, 1993

62. Schwartz, P.E., Chambers, J.T., Taylor, K.J., Cole, L.A., and Makuch, R. Urinary gonadotropin fragments. Anticancer Res., 13:1722-1725, 1993

63. Cole, L.A., Kohorn, E.I., Kim, G.S. Detecting and monitoring trophoblast disease: New perspectives in measuring human chorionic gonadotropin levels. J Reprod. Med. 39:193-200, 1994.

64. Cole, L.A., Nam, J-H., Park, S-Y., Koh, M.W., Tanaka, A. Urinary Beta Core Fragment: 7 years later. J. Tumor Marker Onc., 9:53, 1994

65. Yoshimura, M., Pekary, A.E., Pang, X-P., Berg, L., Cole, L.A., Kardana, A., and Hershman, J.M. Effect of peptide nicking in the human chorionic gonadotropin beta-subunit on stimulation of recombinant human TSH receptors. Eur. J. Endocrinology, 130:92-96, 1994.

66. Cole, L.A., Kardana, A., Seifer, D.B., and Bohler, H.C. Urine hCG b-subunit core fragment, a sensitive test for ectopic pregnancy. J. Clin. Endocrinol. Metab., 78:497-499, 1994.

67. Kardana, A., Cole, L.A. Human chorionic gonadotropin b-subunit nicking enzymes in pregnancy and cancer patient serum. J. Clin. Endocrinol. Metab.,79:761-767, 1994

68. Cole, L.A. b-core fragment (b-core, UGP or UGF). Tumor Marker Update. 6:69-75, 1994.

69. Cole, L.A. Human chorionic gonadotropin and related molecules. Diagn. Endocrinol. Metab., 12:207-224, 1994.

70. Tanaka, A., and Cole, L.A. Improved methods for detecting beta-core in normal and cancer patient urines. Clin. Chem., 40:2317-2318, 1994.

71. Hoermann, R., Berger, P, Spoettl, G., Gillesberger, F., Kardana, A., Cole, L., and Mann, K. Immunological recognition and clinical significance of nicked human chorionic gonadotropin (hCGn) in testicular cancer. Clin. Chem., 40:2306-2312, 1994.

72. Cole, L.A. Multiple hCG-related molecules. In: Screening for Down’s Syndrome (Grudzinskas J., Chard, T., Chapman, M., and Cuckle, H., eds.), Cambridge Univ. Press, Cambridge, pp 119-140, 1994.

73. Goodwin, T.M., Hershman, J.M., and Cole, L.A. Increased concentration of the free b-subunit of human chorionic gonadotropin in hyperemesis gravidarum. Acta Obstet. Gynecol. Scand. 73:770-772, 1994.

74. Fu, C.Y., Cole, L.A. and Kardana, A. Urinary gonadotropin fragment measurement in the monitoring of trophoblastic disease. Chung-Hua Fu Chan Ko Tsa Chih [Chinese Journal of Obstetrics & Gynecology]. 29(8):475-7, 510-511, 1994.

75. Cole, L.A. hCG, nicked hCG, free subunits and fragments in pregnancy, trophoblast disease and cancer. Clin. Chem. 41:26-27, 1995.

76. Cole, L.A., Down’s syndrome screening using urine b-core fragment test; Choice of immunoassay. Prenatal Diagnosis, 25:679-682, 1995.

77. Rotmensch, S., Liberati, M., Kardana, A., Mahoney, M., Hobbins, J.C., and Cole, L.A. Assay of nicked hCG ß-subunit in down syndrome pregnancies. Am. J. Obstet. Gynecol., 174:609-611, 1996.

78. Kardana, A., Braunstein, G.D., and Cole, L.A., Gonadotropin b-subunit nicking enzyme (GBNE), a potential test for detecting early malignancies. Oncology Res., 8:13-16, 1996.

79. Cole, L.A., Tanaka, A., Kim, G.S., Park, S-Y., Koh, M.W., Schwartz, P.E., Chambers, J.T., and Nam, J-H. Beta core fragment (b-core / UGF / UGP), a tumor marker: Seven year report. Gynecol. Oncol., 60:264-270, 1996.

80. Cole, L.A. Multiple hCG-related molecules in pregnancy and trophoblast disease serum and urine samples. In: “Clinical ligand assay society syllabus”, ed. C. D. Hawker, C.L.A.S., Los Angeles, pp 91-99, 1996.

81. Cole, L.A., Isozaki, T., Palomaki, G., Canick, J., Kellner, L., Saller., D., and Cuckle, H. Detection of b-core fragment in second trimester Down’s syndrome pregnancies. Early Human Dev., 47:S47-48, 1996.

82. Schwartz, P.E., Cracchiolo, B.M., Cole, L.A. Clinical application of urinary gonadotropin peptides (UGP) in gynecologic oncology. Anticancer Res., 16:2135-2140, 1996.

83. Cole, L.A. b-core fragment. In: Tumor Markers, Ed. Newlands, E.S., Leeds Univ. Press, Leeds, U.K., 1997.

84. Cole, L.A. Stability of hCG free b-subunit and b-core fragment in urine. Prenat. Diagn., 17:185-189, 1997.

85. Tanaka, A., and Cole, L.A. Comparison of 4 kits for measuring b-core fragment. Jap. J. Clin. Chem., 17: 735-738, 1997.

86. Cole, L.A. b-core fragment in Down syndrome pregnancies. Screen News, 4:9-10, 1997.

87. Isozaki, T., Palomaki, G.E., Bahado-Singh, R.O., Cole, L.A. Screening for Down syndrome pregnancy using b-core fragment: prospective study. Prenat. Diagn. 17:407-413, 1997.

88. Cole, L.A., Leonard H. Kellner, L.H., Isozaki, T., Palomaki, G.E., Iles, R.K., Walker, R., Ozaki, M., and Canick, J. Comparison of 12 assays for detecting hCG and related molecules in urine samples from Down syndrome pregnancies. Pren. Diagn., 17:607-614, 1997.

89. Elliott, M.M., Kardana, A., Lustbader, J.W., and Cole, L.A. Carbohydrate and Peptide structure of the a- and b-subunits of human chorionic gonadotropin from normal and aberrant pregnancy and choriocarcinoma. Endocrine 7, 15-32, 1997.

90. Cole, L.A., Jacobs, M., Isozaki, T., Palomaki, G.E., Bahado-Singh, R.O., Mahoney, M.J. Screening for Down syndrome using urine hCG free b-subunit in the second trimester of pregnancy. Pren. Diagn. 17, 1107-1111, 1997.

91. Cole, L.A., Acuna, E., Isozaki, T., Palomaki, G.E., Bahado-Singh, R.O., Mahoney, M.O. Combining b-core fragment and total estriol measurements to test for Down syndrome pregnancies. Pren. Diagn. 17, 1125-1133, 1997.

92. Cole, L.A. Immunoassay of hCG, its Free Subunits and Metabolites. Clin. Chem., 43: 2233-2243, 1997.

93. Cole, L.A. hCG, its Free Subunits and Metabolites in Pregnancy and Trophoblastic Disease. J. Reprod. Med., 43: 3-10, 1998.

94. Cole, L.A., Cermik D., Bahado-Singh, R. Oligosaccharide variants of hCG-related molecules: Potential screening markers for Down syndrome. Prenat. Diagn. 17:1188-1190, 1997.

95. Cole, L.A. Human chorionic gonadotropin (hCG), free a (free a), free b (free b) and b-core fragment (b-core). Diagn. Endocrinol. Metab., 15:199-220, 1997.

96. Cole, L.A. Human chorionic gonadotropin assay. In: Gestational trophoblastic disease, eds. Hancock B.W., Newlands E.S., and Berkowitz, R.S. Chapman and Hall, London, pp 77-94, 1997.

97. Kardana A., and Cole, L.A. The stability of hCG and free b-subunit in serum samples. Pren. Diagn., 17:141-147, 1997.

98. Cole, L.A., Isozaki, T., Jones, E.E. Urine b-core fragment, a potential screening test for ectopic pregnancy and spontaneous abortion. Fetal Diagn. Ther. 12:336-339, 1997.

99. Bahado-Singh, R.O., Oz, U.A., Daren, O., Acuna, E., Cermik, D., Mahoney, M.J., and Cole, L.A. A new screening protocol combining urine b-core fragment and unltrasound for Down syndrome detection. Am. J. Obstet. Gynecol., 178:779-792, 1998.

100. Bahado-Singh, R.O., Oz, U.A., Kovanci, E., Cermik, D., Flores, D., Copel J., Mahoney, M.J., and Cole, L.A. New triple screen test for Down syndrome: Combined urine analyted and serum AFP. J. Maternal Fetal Med., 7:111-114, 1998.

101. Lee, I-S., Chung, D.Y.K., Cole, L.A., Copel, J.A., Isozaki, T., Hsu, C-D. Elevated serum nicked hCG in preeclamtic pregnancies. Obstet. Gynecol. 90:889-892, 1997.

102. Bahado-Singh, R.O., Oz, U., Isozaki, T., Seli, E., Kovanci, E., Hsu, C-D., and Cole, L.A. Mid-trimester urine b-subunit core fragment levels and the subsequent development of preeclampsia. Am. J. Ob. Gyn., 179:738-741, 1998.

103. Cole, L.A., Omrani, A., Cermik, D., Bahado-Singh, R.O., and Mahoney, R.O. Hyperglycosylated hCG, a potential alternative to hCG in Down syndrome screening. Prenat. Diagn., 18:926-933, 1998.

104. Cole, L.A. Prenatal screening for Down syndrome using hyperglycosylated gonadotropin. PCT Comm., WO98/10282, 1-22, 1998.

105. Cole, L.A., Shahabi, S., Rinne, K.M., Khine, M.L., Bahado-Singh, R.O., Mahoney, M.J. Hyperglycosylated hCG. Down Syndr. News 5:6-7,1998

106. Cole, L.A., Abbott, T.J., Armstrong, G.E. The Nature and Specificity of Bayer Corporation and Chiron Diagnostics hCG Immunoassays. Clin. Chem., 44:2001-2002, 1998

107. Cole, L.A. Early detection of ectopic pregnancy. PCT Comm., WO98/23300, 1-14, 1998.

108. Bahado-Singh, R.O., Oz, U., Flores,D, Cermik, D., Acuna, E., Mahoney, M.J., and Cole, L.A. Nuchal thickness, urine b-core fragment and age for Down syndrome pregnancy. Am. J. Ob. Gyn. 180: 491-495, 1999.

109. Canick, J.A., Kellner, L.H., Cole, L.A., Cuckle, H.S. Urinary analyte screening: A noninvasive detection method for Down syndrome? Molec. Med. Today, 5:68-73, 1999.

110. Cole, L.A. Production, structure, clinical detection and monitoring of hCG in trophoblast disease. Intl. J. Gynecol. Obstet. 60: S131-S132, 1998.

111. Nam, J-H, Kim, J-K, Park, S-Y, Walker, R., and Cole, L.A. Urinary gonadotropin fragment (UGF) measurements, its efficacy in patients with gynecologic and various malignancies. J. Korean Cancer Assoc. 30: 561-572, 1998.

112. Butler, S.A., Cole, L.A., Chard, T., and Iles, R.K. Dissociation of hCG into its free subunits is dependent on naturally occurring molecular structural variation, sample matrix and storage conditions. Ann Clin Biochem, 35:754-760, 1998.

113. Cole, L.A. Rinne, K.M., Mahajan, S.M., Oz, U.A., Shahabi, S., Mahoney, M.J., Bahado-Singh, R.O. Urinary Screening Tests for Fetal Down Syndrome: I. Fresh ß-Core Fragment. Prenat Diagn, 19:340-350, 1999.

114. Cole, L.A. Shahabi, S., Rinne, K.M., Oz, U.A., Bahado-Singh, R.O., Mahoney, M.J. Urinary Screening Tests for Fetal Down Syndrome: II. Hyperglycosylated hCG. Prenat Diagn, 19:351-359, 1999.

115. Cole L.A., Phantom hCG and phantom choriocarcinoma. Gynecol Oncol, 71:325 329, 1998

116. Shahabi, S., Rinne, Oz, U.A., Bahado-Singh, R.O., Mahoney, M.J., Omrani, A., Baugarten, A., and Cole, L.A. Serum hyperglycosylated hCG a potential screening test for fetal Down syndrome. Prenat Diagn, 19:488-489, 1999.

117. Cole, L.A., Rinne, K.M., Shahabi, S., and Omrani, A. False positive hCG levels leading to unnecessary surgery and chemotherapy, and needless occurrences of diabetes and coma. Clin Chem, 45:313-314, 1999.

118. Cole, L.A., Shahabi, S., Bahado-Singh, R. Hyperglycosylated hCG review. Down Syndr News 6:10-11, 1999.

119 Rinne, K, Shahabi, S., and Cole, L.A. Following metastatic placental site trophoblastic tumor with urine b-core fragment. Gynecol Oncol, 74:302-303, 1999.

120. Birken, S., Krichevsky, A., O’Connor, J., Schlatterer, J., Cole, L.A., Kardana, A., and Canfield, R. Development and characterization of antibodies to a nicked and hyperglycosylated form of hCG from a choriocarcinoma patient. Endocrine J., 10: 137-144, 1999.

121. Cuckle, H.S., Shahabi, S., Sehmi, I., Jones, R., and Cole, L.A. Maternal urine hyperglycosylated hCG in pregnancies with Down’s Syndrome. Prenat Diagn, 19: 918-920, 1999.

122. Cole, L.A., Shahabi, S., Oz, U.A., Bahado-Singh, R.O., and Mahoney, M.J. Hyperglycosylated hCG (Invasive Trophoblast Antigen) Immunoassay: a New Basis for Gestational Down Syndrome Screening. Clin. Chem. 45:2109-2119, 1999

123. Bahado-Singh, R., z, U., Kovanci, E., Cermik, D., Mahoney, M.J., and Cole, L.A. A high sensitivity alternative to “routine” genetic amniocentesis: Multiple urinary analytes, nuchal thickness and age. Am J Obstet Gynecol 180:169-173, 1999.

124. Rotmensch, S., and Cole, L.A. False diagnosis and needless therapy of presumed malignant disease in women with false-positive human chorionic gonadotropin concentrations. The Lancet 355:712-715, 2000.

125. Bahado-Singh, R.,Oz, U., Shahabi, S., Omrani, A., Mahoney, M.J., and Cole, L.A. Urine hyperglycosylated hCG plus ultrasound biometry for detection of Down syndrome in the second trimester in a high-risk population. Obstet Gynecol 95:889-894, 2000.

126. Weinans JN, Butler SA, Mantingh A, Cole LA. Urinary hyperglycosylated hCG in first-trimester screening for chromosomal abnormalities. Prenat Diagn., 20:976-978, 2000

127. Kohorn, E.I., Cole, L.A. Nicked human chorionic gonadotropin in trophoblastic disease. Intl. J. Obstet Gynecol., 10:330-335, 2000.

128. Cole, L.A. Dosaggio immunometrico della gonadotropina corionica umana, delle sue subinita libere e dei suoi metaboliti. Ligand Assay 5:70-81, 2000.

129. Bahado-Singh, R., Oz, U., Flores, D., Hsu, C., Mari, G., and Cole, L.A. Maternal urine ß-core fragment level and small for gestational age neonates. Obstetrics and Gynecology, 95:662-666, 2000.

130. Cole L.A. Khanlian S., Butler, S. False-positive hCG immunoreactivity. Lab Medica 18:9-10, 2001.

131. Cole, L.A., Shahabi, S., Butler, S., Mitchell, H., Newlands, E.S., Behrman, H.R., Verrill, H.L. Utility of commonly used commercial hCG immunoassays in the diagnosis and management of trophoblastic diseases. Clin Chem 47:308-315, 2001.

132. Cole, L.A., Butler, S.A. False positive or phantom hCG result: a serious problem. Clin Lab Intl 25:9-14, 2001.

133. Butler S.A., Cole, L.A. The Use of Heterophilic Antibody Blocking Agent (HBT) in Reducing False Positive hCG Results. Clin Chem 47:1332-1333, 2001

134. Butler S.A., Khanlian, S.A., Cole, L.A., Detection of early pregnancy forms of hCG by Home Pregnancy Test Devices, Clin Chem 2001 47: 2131-2136.

135. Cole LA. Use of hCG Tests for Evaluating Trophoblastic Diseases: Choosing an Appropriate hCG Assay, False Detection of hCG, Unexplained Elevated hCG, and Quiescent Trophoblastic Disease. In: Gestational Trophoblastic Disease, 2nd Edition (Eds: Hancock BW, Newland ES, Berkowitz RS), Chapman and Hall, London, in press, 2002.

136. Bahado-Singh R.O., Oz, A.U., Kingston, J.M., Shahabi, S., Hsu, C.D., and Cole, L.A. The role of hyperglycosylated hCG in trophoblast invasion and the prediction of subsequent pre-eclampsia. Prenat Dagn 22:478-481, 2002.

137. Butler S.A., Cole, L.A. Falsely elevated hCG leading to unnecessary therapy Obstet Gynecol, 99:515-516, 2002.

138. Cole, L.A. and Butler S.A., hCG, its Free Subunits and Metabolites in Trophoblastic Diseases. J. Reprod. Med. 47:433-444, 2002.

139. Bahado-Singh RO, Shahabi S, Karaca M, Mahoney MJ, Cole LA, Oz UA. The comprehensive midtrimester test: high-sensitivity Down syndrome test. Am J Obstet Gynecol 186:803-808, 2002.

140. Cole LA. ITA (hyperglycosylated hCG) a powerful serum and urine screening method in maternal Down syndrome detection: Update 2002, Down Syndr News 9:25, 2002

141. Smith HO, Hilgers RJ, Qualls CR, Bedrick EJ, Prairie BA, Rayburn WF, Waxman AG, Stephens ND, Padilla LA, Cole, LA, Swanson M, Wiggins CL, Key CR, Ethnic trends in gestational trophoblastic d in New Mexico, and trends in choriocarcinoma. Trophobl Dis Upd, 4:9-12, 2002.

142. Cole LA, Hyperglycosylated hCG cannot be measured using a sialic acid-specific lectin immunoassay. Prenat Diagn 23: in press, 2003

143. Khanlian SA, Smith HO, Cole LA. Persistent Low Levels of hCG: A Pre-malignant gestational trophoblastic disease. Am J Obstet Gynecol, in press, 2003.