Early ovarian cancer detection has long been one of medicine's greatest challenges — and for good reason. Over 80% of patients aren't diagnosed until late stages, when 5-year survival rates drop from ~90% (stage I) to as low as 20% (stage IV). Current biomarkers like CA-125 and HE4 often miss early-stage disease and can be falsely elevated by benign conditions like endometriosis, making them unreliable screening tools.

Two liquid biopsy technologies are now showing real promise. Mercy BioAnalytics' Evident test detects cancer-associated signatures on extracellular vesicles (EVPs) — particles secreted by living tumor cells even in early stages — achieving 89% sensitivity and 98% specificity for early-stage ovarian cancer in retrospective analysis. DELFI Diagnostics' DELFI-Pro uses machine learning to analyze cell-free DNA fragmentation patterns alongside CA-125 and HE4, hitting ~72% sensitivity for stage I at >99% specificity — more than double CA-125 alone (34%).

By the Numbers:

• Stage I ovarian cancer 5-year survival: ~90%
• Stage III: ~40% | Stage IV: ~20%
• Over 80% of patients are diagnosed at late stages
• Evident test: 89% sensitivity, 98% specificity (early-stage)
• DELFI-Pro: ~72% sensitivity for stage I vs. 34% for CA-125 alone

Why it matters: These tools could fundamentally shift ovarian cancer outcomes by catching the disease when it's most treatable. The Evident test has FDA Breakthrough Device Designation and is targeting full approval by 2028, while DELFI-Pro is already available as a lab-developed test for lung cancer — with ovarian cancer next in line.