What is the OvPlex™ Diagnostic?
OvPlex™ is a superior performing alternative to CA125 for
the diagnostic process to check for ovarian cancer in symptomatic
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
- OvPlex™ is a superior performing alternative to CA125
- OvPlex™ is not designed to be used as a population screening
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,
- 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
- Traditional CA125 values are
also provided for reference.