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Cancer Epidemiol Biomarkers Prev. Author manuscript; available in PMC 2017 September 01. Published in final edited form as:

Cancer Epidemiol Biomarkers Prev. 2016 September ; 25(9): 1333–1340. doi: 10.1158/1055-9965.EPI-15-1299.

Validation of a novel biomarker panel for the detection of ovarian cancer Felix Leung1,2, Marcus Q. Bernardini3, Marshall D. Brown4, Yingye Zheng4, Rafael Molina5, Robert C. Bast Jr.6, Gerard Davis7, Stefano Serra8, Eleftherios P. Diamandis1,2,9, and Vathany Kulasingam1,9,* 1Department

of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario,

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Canada 2Department

of Pathology and Laboratory Medicine, Mount Sinai Hospital, Toronto, Ontario,

Canada 3Division

of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Toronto, Toronto, Ontario

4Fred

Hutchinson Cancer Research Center, Seattle, Washington, United States of America

5Service

of Clinical Biochemistry, Hospital Clínic de Barcelona, Barcelona, Spain

6Department

of Experimental Therapeutics, University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America

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7Abbott

Diagnostics, Lake Forest, Illinois, United States of America

8Department

of Pathology, Laboratory Medicine Program, University Health Network, Toronto, Ontario, Canada

9Department

of Clinical Biochemistry, University Health Network, Toronto, Ontario, Canada

Abstract Background—Ovarian cancer (OvCa) is the most lethal gynecological malignancy. Our integrated -omics approach to OvCa biomarker discovery has identified kallikrein 6 (KLK6) and folate-receptor 1 (FOLR1) as promising candidates but these markers require further validation.

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Methods—KLK6, FOLR1 CA125 and HE4 were investigated in three independent serum cohorts with a total of 20 healthy controls, 150 benign controls and 216 OvCa patients. The serum biomarker levels were determined by ELISA or automated immunoassay. Results—All biomarkers demonstrated elevations in the sera of OvCa patients compared to controls (p0.7752 and HE4>703

31% (26–38)

2% (0–4)

81% (75–86)

32% (25–39)

+ FOLR1>0.7752

62% (56–68)

12% (7–18)

+ KLK6>2.0752

36% (30–42)

9% (5–14)

+ CA125>351 and FOLR1>0.7752

60% (53–66)

5% (2–9)

Rule CA125>351

HE4>703

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*

TPF = true positive fraction;

°

FPF = false positive fraction

1

U/mL;

2

ng/mL;

3

pmol/L

Author Manuscript Author Manuscript Cancer Epidemiol Biomarkers Prev. Author manuscript; available in PMC 2017 September 01.