open access: Performance of a multianalyte test as an aid for the diagnosis of ovarian cancer in symptomatic women (comparison to CA-125)

Performance of a multianalyte test as an aid for the diagnosis of ovarian cancer

Performance of a multianalyte test as an aid for the diagnosis of ovarian cancer in symptomatic women

Journal of Translational Medicine 2012, 10:45 doi:10.1186/1479-5876-10-45

Publication date 12 March 2012
Article URL http://www.translational-medicine.com/content/10/1/45

"The study population comprised 244 apparently healthy normal women, 223 patients with benign gynecological conditions, 53 patients with borderline ovarian tumours and 222 patients with malignant ovarian tumours (serous, mucinous, endometrioid, clear cell, other)  (Table 1)."

"The malignant ovarian cancer cohort comprised 130 (58.5%) serous, 19 (8.6%)endometrioid, 16 (7.2%) mucinous, 16 (7.2%) clear cell and 41 (18.5%) of other types that included predominantly mixed forms and adenocarcinomas with no specific histotype recorded (Table 1). A total of 33 (14.9%) of malignant ovarian cancer samples had no staging data reported, 42 (18.9%) were diagnosed with Stage I disease, 27 (12.2%) with Stage II, 106 (47.7%) Stage III and 14 (6.3%) with Stage IV disease (Table 1)."

"Of the ovarian malignancies, 88.5% of all serous tumours, 57.9% of all endometrioid tumours, 62.5% of all mucinous tumours, 81.2% of all clear cell tumours and 85.4% of other epithelial ovarian cancer plasma samples were correctly identified (Table 5). The IVDMIA correctly predicted 91.7% of the late stage (Stages III-IV) samples, and 69.6% of the early stage (Stages I-II) malignant ovarian cancer samples (Table 5).

Conclusions
This study confirms in an independent sample set that a blood-based multianalyte assay has significant advantages over CA125 for distinguishing symptomatic women with borderline and malignant ovarian cancer from controls or those with benign disease.

Competing interests
This study was funded as part of the research and development activities of Healthlinx Ltd. DJA, LR, KK and KB are employees of Healthlinx Ltd and GER is non-executive chairman of Healthlinx Ltd. DJA is an inventor on patent applications that are related to the current
study.

Keywords
Ovarian cancer, Tumour markers, Multianalyte, Diagnostic
Background

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The test, approved last September, costs $650 and is reimbursed at $540 by Medicare, according to the company. (assuming U.S. dollars)