Adnexal Mass Evaluation: A Critical Diagnostic Challenge

Distinguishing malignant from benign masses before surgery remains one of gynecology's most vexing problems.

We are developing OvaPrint as a reliable tool to discriminate between benign and malignant adnexal masses.

Each year in the United States, over 200,000 women undergo surgery for adnexal masses¹. Behind each of these numbers is a woman facing profound uncertainty, a physician navigating with inadequate tools, and a healthcare system struggling with the consequences of diagnostic limitations.

Consequence #1: Surgical Overtreatment
More than 80% of women who undergo surgery for suspected malignancy have benign disease². Unnecessary surgeries carry complications, fertility loss, recovery time, financial burden.

Consequence #2: Surgical Undertreatment and Diagnostic Delays
Patients with adnexal masses who are ultimately found to have ovarian cancer but are not initially treated by a gynecologic oncologist are at higher risk of incomplete staging and suboptimal surgical treatment. This frequently results in the risk for cancer upstaging, increased morbidity, and overall worse survival³.

80%

of women who undergo surgery for suspected malignancy have benign disease²

Our solution

Clinical Uncertainty, Higher Cost,
and Poor Outcomes.

Patient experience long wait times for gynecologic oncology consultations, ACOG/SGO guidelines show only 58.1% positive predictive value for referrals (postmenopausal) and 39.6% (premenopausal), with 85% of specialist referrals revealing benign disease⁵. 99% of gynecologic oncologists practice in metropolitan counties and 91.2% of U.S. counties have no gynecologic oncologist⁶. Fear of missing malignancy drives defensive medicine to "do something" even with uncertain findings.

We Can Change This

The diagnostic gap isn't experienced equally

Black and Indigenous American patients are 23% less likely to receive ovarian cancer diagnosis with tools validated using 80-98% White populations⁷.

Financial toxicity affects 47% of gynecologic cancer patients. Only 39% of patients receive recommended testing, varying by insurance status⁸.

99% of gynecologic oncologists work in metropolitan counties, with only 13% practicing in areas with populations <50,000⁹.

The Urgent Need for Innovation

The medical community needs better tools to distinguish malignant from benign masses before surgery across all populations.
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Adnexal Mass Discovery

Reliable diagnostics

What Better Diagnostics Must Deliver

Specificity to minimize false positives

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.

High Negative Predictive Value to avoid overtreatment

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.

High sensitivity for early-stage detection

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.

Consistent performance across all populations

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.

Clear, actionable results

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.

Accessibility regardless of geography and status

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.

AACR

Clin Cancer Res (2023) 29 (24)

Molecular Diagnostics Leveraging DNA Methylation and Artificial Intelligence Offer Hope

Accurate Detection

Cancer-specific molecular signatures that distinguish malignant from benign tissue.

Constantly Improving

AI-powered pattern recognition that improves with each sample analyzed.

Minimally Invasive

Liquid biopsy approaches requiring only a simple blood draw

Our Solution

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