Bio-analytical solutions firm Vermillion has received CE mark approval for its next generation OVA1 test to detect the risk of malignancy for ovarian cancer.
Earlier referred to as OVA2, the next-generation test was trademarked as Overa by the company.
Overa is a simple blood test that enables physicians to assess the likelihood of ovarian cancer in connection with a suspicious pelvic mass.
The test is said to be used, along with the physician’s overall clinical assessment, to help guide pre-surgical risk assessment and decision-making.
Overa assesses the levels of five proteins in the blood and then uses a 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.
Vermillion president and CEO Valerie Palmieri said: "Coupling an early risk assessment test for ovarian cancer with a global distribution platform, the Roche cobas 6000, should make for significant strides in early detection of ovarian cancer worldwide.
"We are actively identifying global partnerships and are confident that general practitioners in the European Union will embrace Overa’s industry-leading, clinically validated technology."
The firm revealed the results of validation testing for Overa, including significant improvement in specificity at 69%, an improvement of 28% compared against OVA1 test.
The results also showed that positive predictive value (PPV) increased from 31% (OVA1) to 40% (Overa), an improvement of 29% in a head to head comparison with the same patient population.
According to the firm, Overa is currently under review by the US Food and Drug Administration.
Vermillion is involved in developing and commercializing novel diagnostic and bio-analytical solutions to diagnose, treat and improve gynecologic health.
Image: Micrograph of serous carcinoma, a type of ovarian cancer. Photo: courtesy of Nephron.