- OVA1 is a proprietary FDA-cleared blood test to help physicians assess the risk of ovarian cancer prior to surgery and as a result provide early detection and triage of high risk patients to a specialist (gynecologic oncologist) for surgical treatment
- The OvaCalc® proprietary algorithm combines five biomarker results into a single numerical "risk score" that stratifies patients into "higher risk" and "lower risk" when combined with clinical assessment
- In two pivotal clinical trials, OVA1 plus clinical impression detected 96% of all malignancies vs. 75% for clinical impression alone. It subsequently reduced false negatives from 25% to 4%, a reduction of 83%
- For early-stage cancers specifically, on average 31% are missed by clinical impression alone. This was reduced to 5% when OVA1 was added to clinical impression, a reduction of 85%
- Overa, FDA-cleared on March 18, 2016, measures the levels of five proteins found in the blood and then uses a proprietary software called OvaCalc® to calculate a single score. A woman's risk of cancer is measured by using a 0-10 scale with a single cut-off point of 5 eliminating the ambiguity in determining menopausal status. A high Overa score is not a diagnosis of cancer, rather it indicates an increased risk of malignancy when used as intended.
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