Two biotechnology firms, Mercy BioAnalytics and DELFI Diagnostics, are developing liquid biopsy tests designed to catch ovarian cancer in its earliest stages, offering significantly higher sensitivity than standard screening methods like CA-125 and HE4.
Early Detection Rates and the Stages of Ovarian Cancer
Catching ovarian cancer early remains a major hurdle in oncology because more than 80% of patients are not diagnosed until later, advanced stages, according to the article. This delay happens partly because early-stage tumors generate no obvious symptoms and standard blood biomarkers such as CA-125 and HE4 are rarely released at high enough concentrations for early detection.
The stakes for early diagnosis are remarkably high. When a patient receives a stage I diagnosis, the five-year survival rate reaches nearly 90%. That figure drops sharply to roughly 40% by stage III once the cancer spreads beyond the pelvis, and plummets to about 20% by stage IV as the disease expands to the lungs, liver, or outer lymph nodes.
Early detection has been the holy grail in the field for decades
Dr. Ron Drapkin, Director of the Penn Ovarian Cancer Research Center
Standard protein tests also struggle with specificity. Biomarkers like CA-125 can be elevated due to benign conditions such as fibroids and endometriosis.
Mercy BioAnalytics Uses Extracellular Vesicles to Flag Cancer
To overcome the limitations of traditional protein biomarkers, Mercy BioAnalytics designed a blood-based liquid biopsy that flags cancer signatures carried by extracellular vesicles and particles (EVPs). Unlike circulating tumor DNA (ctDNA), which early-stage tumors shed in quantities too small for reliable detection, living tumor cells secrete EVPs right from the start of tumor development.
The test relies on biomarker colocalization, analyzing three distinct biomarkers simultaneously to spot true cancer signals against the healthy biological background. Our test is very good at distinguishing the healthy background from the tumor signal,
stated Guettouche, an employee of Mercy BioAnalytics.
In a retrospective analysis using preclinical samples from the UKCTOCS trial involving postmenopausal patients without elevated risk, the test achieved 89% sensitivity and 98% specificity for early-stage detection. Mercy BioAnalytics secured FDA Breakthrough Device Designation in 2024, applied for full FDA approval with a target date of 2028, and currently makes the test available as a laboratory-developed test in Texas, Florida, and Georgia.
DELFI Diagnostics Analyzes DNA Fragmentation Patterns
Competing in the same space, DELFI Diagnostics utilizes a machine learning model to examine fragmentation patterns in cell-free DNA (cfDNA), pairing this analysis with measurements of HE4 and CA-125. Because tumor DNA fragmentation patterns remain unaffected by benign conditions, the method adds vital stringency. A 2025 Cancer Discovery paper co-authored by Dr. Drapkin showed that the DELFI-Pro test achieved roughly 72% sensitivity for stage I ovarian cancer at a specificity exceeding 99%, outperforming standalone or combined protein biomarker panels.
DELFI Diagnostics already offers a cfDNA fragmentation test as a laboratory-developed test for lung cancer and intends to expand availability to ovarian cancer. Meanwhile, Dr. Drapkin’s team is building a precancer atlas to map early cellular transformations, collaborating with DELFI Diagnostics to test whether newly discovered markers can boost the sensitivity of the DELFI-Pro platform.
Related reading
Discover more from Archyworldys
Subscribe to get the latest posts sent to your email.