US-based molecular diagnostics firm Vermillion has secured CE Mark for its next-generation OVA1 test to detect the risk of malignancy for ovarian cancer.
The OVA1 test is currently cleared for marketing in the European Union (EU). Previously referred to as OVA2, the next-generation test was trademarked as Overa by the company.
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Overa is a simple blood test that allows physicians to assess the likelihood of ovarian cancer in connection with a suspicious pelvic mass.
The test is designed for use along with the physician’s overall clinical assessment, to help guide pre-surgical risk assessment and decision making.
It evaluates the levels of five proteins in the blood and uses proprietary software known as OvaCalc to calculate a single score. The test will measure woman’s risk of cancer by using a 0-10 scale versus a single cut-off point of five.
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Vermillion CEO Valerie Palmieri said: "Coupling an early risk assessment test for ovarian cancer with a global distribution platform, the Roche cobas 6000, should make significant strides in early detection of ovarian cancer worldwide.
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By GlobalData"We are actively identifying global partnerships and are confident that general practitioners in the EU will embrace Overa’s industry leading, clinically validated technology."
"This technology can be used to detect all stages of ovarian cancer, at all patient ages, for all ovarian cancer types.
"Our ultimate goal is stage shift ovarian cancer detection, from the majority being diagnosed at stage three and four with less than 50% survival, to stage one and two, where 80 – 90% of patients survive.
"This is a historic moment for the company and women worldwide."
The company noted the results of validation testing for Overa show significant improvement in specificity at 69%, an improvement of 28% compared against the OVA1 test.
Results also showed that positive predictive value (PPV) increased from 31% (OVA1) to 40% (Overa), an improvement of 29% compared with the same patient population.
According to the company, Overa is currently under review by US Food and Drug Administration (FDA).
The company is focused on developing and commercialising new diagnostic and bio-analytical solutions to diagnose, treat and improve gynaecologic health.
