OvPlex™

What is the OvPlex™ Diagnostic?

OvPlex™ is a superior performing alternative to CA125 for the diagnostic process to check for ovarian cancer in symptomatic women.

OvPlex™ is a diagnostic test that measures levels of five proteins in a patient’s blood. One of the proteins is CA125, which has been used for several years for the detection and monitoring of ovarian cancer. When measured along with the four additional proteins that make up OvPlex™, a significant enhancement in diagnostic performance can be achieved.

• OvPlex™ is a new multimarker blood test for ovarian cancer

• OvPlex™ measures five blood borne biomarkers associated with ovarian cancer

• OvPlex™ is a superior performing alternative to CA125 alone

• OvPlex™ is not designed to be used as a population screening test

The multimarker test results are processed using an algorithm to generate a single OvPlex™ value which represents the likelihood that a woman has ovarian cancer.

In addition to the OvPlex™ value, traditional CA125 values are also provided for reference.

OvPlex™ uses the minimally invasive methodology required by a simple blood test.

Performance of the OvPlex™ multimarker test is based on a recent retrospective biomarker trial of 362 samples consisting of 150 patients with confirmed ovarian cancer and 212 that were free of disease (Edgell et al, 2010). Based upon the analysis of Receiver Operator Characteristic (ROC) Curves, OvPlex™ significantly out performs the CA125 blood test, for both early and late stage disease.

For the detection of ovarian cancer overall, OvPlex™ delivers 94.0% specificity, 94% sensitivity and an overall diagnostic efficiency of 94% when used at a threshold of 0.45. OvPlex™ reduces the overall false negative rate by up to 19% and the false positive rate by 42% compared with using CA125 alone. For the detection of early stage (stage I and stage II) disease, the OvPlex™ multimarker test also outperformed the use of CA125 alone, delivering 92% sensitivity and 94% specificity in the biomarker trial.

The enhanced performance of OvPlex™, particularly with respect to detection of early stage ovarian cancers suggests that it will provide significant benefits in terms of diagnostic performance over the use of CA125 alone.

OvPlex™ is not intended to be used as a screening test but as an additional aid by medical professionals as part of the routine diagnostic procedure to assess the potential for ovarian cancer in symptomatic women.

Further technical information regarding the performance characteristics of the OvPlex™ multimarker test can be obtained in the Independent Biostatistician Report and the peer reviewed manuscript (Edgell et al, 2010).

Independent Biostatistician Report

Peer Reviewed Manuscript (Edgell et al, 2010)

The Benefits

• Displays better diagnostic performance than CA125 alone, both for the detection of early and late stage ovarian cancer. At a threshold of 0.45, OvPlex™ displays, 94% sensitivity and 94% specificity.
• May improve the detection of ovarian cancer. At equivalent specificity with CA125, OvPlex™ delivers 97% sensitivity.
• May reduce the false negative rate of CA125 by up to 19% and the false positive rate by up to 42%.
• Traditional CA125 values are also provided for reference.