CleoDX is changing the face of women’s healthcare
Assessing Risk of Malignancy for Patients
with Adnexal Mass
Ovarian cancers comprise a related group of neoplasms typically characterised by late presentation and vague symptoms.
When a patient presents with an adnexal mass it is up to the clinician to determine the risk of malignancy, and triage patients appropriately for further surgical follow-up as needed.
The standard clinical workflow using transvaginal ultrasound, CA-125, and any clinical features (including family history) is often not sufficient to accurately discriminate benign from malignant disease; and diagnostic certainty is outweighed by the need to mitigate risk. As a result up to 90% of patients referred for exploratory surgery of a suspicious adnexal mass are ultimately diagnosed with benign disease.
Conversely, less than 50% of all ovarian cancer patients receive a primary referral to a gynecological oncology specialist. Front-line clinicians need better tools to enhance confidence in the decision making process, and help guide patients to the best clinical care.
How is it administered?
A single serum test is ordered through a pathology provider in the same way as any other blood test. The test is performed and the results returned directly to the physician office.What does the report tell me?
The Test Report will define the level of each biomarker measured, and provide a score indicating the Risk of Malignancy. This Risk of Malignancy score provides an overall assessment of malignancy risk, and in conjunction with imaging and a clinical opinion helps to identify the requirement for further consultation with a gynaecological oncology specialist.
How does this help patients?
Early and direct referral to an oncology specialist is a critical determinant in overall treatment outcomes for ovarian cancer patients. The Cleo Pre-Surgical Triage Test helps to make the critical decision regarding the risk of malignancy at an early point in the consultation process. Sending patients immediately to an appropriate specialist has far-reaching impact for their journey.
It also means that more conservative strategies can be considered for those patients who are unlikely to have malignant disease.
What is the CleoDX Pre-surgical Triage test?
The CleoDX Pre-Surgical Triage Test measures a combination of 5 biomarkers in serum to provide an accurate determination of malignancy risk prior to surgical referral. It leverages the discovery that a protein “CXCL10” undergoes cancer-specific modification, early during cancer progression, and is released into circulation.
This provides a highly specific and sensitive predictor for the presence of malignant ovarian tumours at all stages, as well as an excellent negative predictor to exclude benign disease.
Who is it for?
The CleoDX Pre-Surgical Triage Test is intended for patients with a radiologically imaged adnexal mass, and who would typically have a blood test for CA-125 (and / or other markers) as part of their clinical work-up to determine risk of malignancy. The CleoDX test provides a far more accurate risk prediction, and is a replacement for outdated CA-125 technology.
Development of the CleoDX Pre-Surgical Triage Test
The CleoDX Pre-Surgical Triage Test was developed to aid physicians in determining whether a patient presenting with an adnexal mass has an ovarian malignancy or benign ovarian disease.
The Cleo DX test is based on a unique understanding of tumour biology and measures the “Active Ratio” of CXCL10 chemokine in combination with 3 supplementary biomarkers indicative of the presence of ovarian malignancy.
The biomarkers were selected from a retrospective cohort study of 275 patients and further evaluated in three subsequent studies.
The CleoDX Test quantifies the CXCL10 active ratio combined with CA125, HE4 and IL6 to provide a numerical Risk of Malignancy for the patient.
The CleoDX Pre-Surgical Triage Test
Details of the the overall sensitivity, specificity, positive and negative predictive values of the CleoDX Pre-Surgical Triage Test in a retrospective clinical cohort. The test was shown to provide a significant and substantial improvement over the use of CA125 to predict malignancy status in patients triaged due to indeterminate ultrasound findings.
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Improved identification of malignancy in patients with ambiguious CA125
CA125 <35U/ml is considered a normal range, and can delay secondary referrals due to diminished confidence in malignancy risk prediction. The CleoDX pre-Surgical Triage Test provided up to 71% improvement in the detection of “low CA-125” malignancy, as well as excluding up to 90% of patients with benign disease who had elevated (>200U/ml) CA125.
Improved Ultrasound-Based workflows
Combination of the CleoDX test with transvaginal ultrasound imaging provides greatly enhanced ability to discern between benign and malignant disease. In particular the positive predictive value – that is the ability to correctly identify malignancy in the overall cohort – increases to 92.9% when CleoDX triage test is used with ultrasound findings, compared to 66.1% using the standard CA-125.
In addition, up to 90% of “early stage” cancers – those at stages I or II of progression – could be correctly assigned using the CleoDX / TVU approach.
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