Liquid Biopsy Platform Shows Promise for Early Gynecologic Cancer Detection

Earlier cancer detection remains a diagnostic need in ovarian cancer, described as one of the deadliest cancers affecting women. A new multi-omics liquid biopsy platform now reports cancer-associated signals across ovarian, endometrial, and cervical cancers, while its lead ovarian cancer assay advances toward commercial-scale testing.

AOA Dx’s lead test, Omira OC, previously known as AKRIVIS GD, is designed to detect ovarian cancer early in symptomatic women. The assay was developed from more than 9,000 candidate discovery features, which have been reduced to a targeted panel of fewer than 10 features. It is designed to run on mass spectrometry and immunoassay systems already operating in high-throughput clinical laboratories, without requiring entirely new laboratory infrastructure. The company’s proprietary platform integrates lipids, metabolites, proteins, and clinical data using advanced machine learning.

New data presented at two scientific meetings showed cancer-associated signals across ovarian, endometrial, and cervical cancers, including early-stage disease. In an independent hold-out patient set, Omira OC achieved an area under the curve of 0.97 for distinguishing ovarian cancer from symptomatic non-cancer conditions.

The assay also achieved an area under the curve of 0.96 for stage I/II disease and maintained high specificity when challenged against conditions known to cause false positives with existing ovarian cancer biomarkers. Using a targeted lipid panel, the platform demonstrated 95.7% sensitivity for early-stage endometrial cancer and 94.4% sensitivity for early-stage cervical cancer at 90% specificity. AOA Dx is also evaluating the platform in cancers outside gynecologic oncology, with additional data expected at a later date.

“We started with ovarian cancer, and we have always been building for something much bigger. We now have a clinical-grade ovarian cancer assay designed for commercial-scale infrastructure, while the biology behind our platform is showing strong signals across additional cancers. We are moving from one product to a pipeline of oncology diagnostics,” said Oriana Papin-Zoghbi, CEO and Co-Founder of AOA Dx.

“This is what makes the data so exciting and meaningful. We have taken complex discovery and multi-omic data sets, translated them into a targeted and reproducible clinical assay, and are now seeing that the biological pathways extend across multiple cancers. That gives us a foundation of biomarkers to build well beyond our first indication. The potential for the early detection field and for other disease states is high,” said Abby McElhinny, Chief Scientific Officer of AOA Dx.

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