We developed a novel proteomic diagnostic assay for detection of epithelial ovarian cancer,
offering:
• High sensitivity for early stage disease to increase the likelihood of cure.
• High specificity for potential delay of risk-reducing surgical procedure.
• Early ovarian cancer diagnosis for all age-groups and risk-groups (i.e., BRCA carriers).
THE NEED
Over 240,000 new cases of ovarian cancer are identified world wide each year.
There is an urgent unmet need for early detection screen for ovarian cancer, resulting in late
diagnosis of ~80% of cases, and low survival rates. As a result, women with high risk for ovarian
cancer, such as carriers of BRCA mutations carriers, undergo prophylactic surgical removal of the
ovaries.
• US market potential of high risk women at age >30 – 1M tests / year
• US market potential of average risk women over age 50 – 50M tests/ year
THE TECHNOLOGY
• A liquid biopsy from the gynecological tract, obtained by a minimally-invasive uterine lavage.
• Easily performed in the clinic, without imaging, anesthesia or expensive disposables.
• Liquid microparticle proteomes are analyzed through high resolution mass spectrometry.
• Can be easily translated to an immunoassay.
CURRENT DEVELOPMENTAL STAGE
• Over 700 uterine lavage liquid biopsies tested in a multi-center clinical trial (ClinicalTrials.gov
Identifier: NCT03150121).
• Predictive protein-based classifier for BRCA mutation carriers with 98.5% sensitivity and
91.5% specificity.
• Diagnostic classifier for non-BRCA cases has 99% sensitivity and 65% specificity.
• Independent validation set.
• 100% sensitivity for stage 1 tumors.