Current tests like CA-125 and OVA1 suffer from specificities as low as 35-50%, creating a cascade of unnecessary interventions. With 70-85% of surgically removed masses proving benign, each false positive triggers unneccesary surgical costs, potential fertility loss, and weeks of recovery time.

Higher specificity would reduce false positive rates, preventing thousands of unnecessary surgeries annually while maintaining the sensitivity needed to catch true malignancies.

When a test can reliably rule out cancer with superior accuracy, physicians gain the confidence to recommend conservative management rather than immediate surgery. This metric is particularly critical for premenopausal women, where only 5-15% of masses are malignant, and preserving fertility is paramount.

High NPV (Negative Predictive Value) enables "watchful waiting" strategies, reducing both healthcare costs and patient morbidity while ensuring that the rare malignant cases are not missed.

Current biomarkers miss 50% of Stage I ovarian cancers, when 5-year survival exceeds 91%. Early-stage sensitivity is the difference between a manageable diagnosis and a terminal one—survival drops from 91.7% at localized stage to 31.8% at distant stage.

Advanced diagnostics must detect the subtle molecular signatures present in early disease, catching cancer when it's confined to the ovaries and most responsive to treatment.

Current diagnostics based on CA-125 shows 23% lower detection rates in Black and American Indian patients, contributing to a 28% increased mortality risk for Black women with ovarian cancer. These disparities stem from validation studies using 80-98% White populations, creating built-in bias.

Next-generation diagnostics must be validated across diverse populations from development through deployment, ensuring equitable performance regardless of race, ethnicity, or genetic background.

Current multivariate assays generate complex risk scores that require interpretation, leading to clinical uncertainty and delayed decision-making.

Physicians need binary, definitive results—high risk or low risk—with clear management pathways for each outcome. This clarity reduces medico-legal concerns, streamlines referral decisions, and enables confident communication with patients about their diagnosis and treatment options.

With 91.2% of U.S. counties lacking a gynecologic oncologist and 14.8 million women living over 50 miles from specialist care, diagnostics must be deployable in any clinical setting. This means simple blood draws that can be collected in rural clinics, shipped without specialized handling, and processed with standardized protocols.

True accessibility also requires insurance coverage and price points that don't create additional barriers to care for underserved populations.