Positive Results from Ovarian Cancer Diagnostic Trial
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By LabMedica International staff writers Posted on 01 Aug 2012 |
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A molecular diagnostics company announced positive results from a new prospective, multicenter clinical study of its ovarian cancer diagnostic.
The study, referred to as OVA500, was led by Dr. Robert E. Bristow, director of gynecologic oncology services at University of California (UC) Irvine Healthcare in (Orange, CA, USA).
OVA1, a product of Vermillion (Austin, TX, USA), is the first protein-based, in vitro diagnostic multivariate index assay cleared by the US Food and Drug Administration (FDA; Silver Spring, MD, USA) and represents a new class of software-based diagnostics. It is a blood test for the presurgical assessment of ovarian tumors for malignancy using a multi-biomarker approach.
The primary objective of the multicenter study was to assess the performance of OVA1 in the intended use population with a focus on two particularly challenging subgroups: women with early-stage ovarian cancer, where approximately half of patients have a normal CA125 level, and premenopausal women, where the incidence of ovarian cancer is low and incidence of benign cysts is high. All adnexal tumor types were included in the statistical analysis of test performance.
The overall study found that the negative predictive value was 98%. Sensitivity of the test was 94 % and specificity was reported at 51%. In the premenopausal population, sensitivity was reported at 94%. For early-stage, ovarian cancer (I and II) sensitivity was reported at 91%.
"These new results point to the possibility of a standardized triage protocol using OVA1, with high sensitivity for all ovarian malignancies including the most curable early-stage cases and a broad range of subtypes," noted Dr. Bristow.
Related Links:
University of California Irvine Healthcare
Vermillion
US Food and Drug Administration
The study, referred to as OVA500, was led by Dr. Robert E. Bristow, director of gynecologic oncology services at University of California (UC) Irvine Healthcare in (Orange, CA, USA).
OVA1, a product of Vermillion (Austin, TX, USA), is the first protein-based, in vitro diagnostic multivariate index assay cleared by the US Food and Drug Administration (FDA; Silver Spring, MD, USA) and represents a new class of software-based diagnostics. It is a blood test for the presurgical assessment of ovarian tumors for malignancy using a multi-biomarker approach.
The primary objective of the multicenter study was to assess the performance of OVA1 in the intended use population with a focus on two particularly challenging subgroups: women with early-stage ovarian cancer, where approximately half of patients have a normal CA125 level, and premenopausal women, where the incidence of ovarian cancer is low and incidence of benign cysts is high. All adnexal tumor types were included in the statistical analysis of test performance.
The overall study found that the negative predictive value was 98%. Sensitivity of the test was 94 % and specificity was reported at 51%. In the premenopausal population, sensitivity was reported at 94%. For early-stage, ovarian cancer (I and II) sensitivity was reported at 91%.
"These new results point to the possibility of a standardized triage protocol using OVA1, with high sensitivity for all ovarian malignancies including the most curable early-stage cases and a broad range of subtypes," noted Dr. Bristow.
Related Links:
University of California Irvine Healthcare
Vermillion
US Food and Drug Administration
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