New data show high diagnostic performance for ovarian, endometrial, and cervical cancers, with a targeted assay designed to run on existing clinical laboratory equipment.
Biotechnology company AOA Dx announced new data demonstrating cancer-associated signals across ovarian, endometrial, and cervical cancers, including strong diagnostic performance in early-stage disease.
Presented at MSACL and EDCC, the findings mark the expansion of the company’s multi-omics liquid biopsy platform beyond its initial focus on ovarian cancer. The announcement follows the development of its lead diagnostic, Omira OC (previously AKRIVIS GD), which has transitioned from broad biomarker discovery into a targeted, clinical-grade assay designed to operate on mass spectrometry and immunoassay infrastructure already present in high-throughput clinical laboratories.
“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,” says Oriana Papin-Zoghbi, CEO and co-founder of AOA Dx, in a release.
Translating Multi-Omics Discovery to Scalable Panels
Omira OC was derived from an initial discovery pool of more than 9,000 candidate features, which researchers refined into a targeted panel of fewer than 10 features.
In an independent hold-out patient cohort, Omira OC delivered an area under the curve (AUC) of 0.97 for distinguishing ovarian cancer from symptomatic non-cancer conditions, as well as an AUC of 0.96 for early-stage (I/II) disease. In addition, the assay maintained high specificity when challenged with conditions known to generate false-positive results in established ovarian cancer biomarkers.
Because the assay is tailored for mass spectrometry and immunoassay equipment currently operating in clinical testing environments, clinical laboratories can implement the testing protocol without adopting entirely new hardware platforms.
Extending Detection to Endometrial and Cervical Cancers
Beyond ovarian cancer, AOA Dx evaluated whether the coordinated metabolic alterations identified by its technology apply across other gynecologic malignancies. Utilizing a targeted lipid panel, the platform demonstrated 95.7% sensitivity for early-stage endometrial cancer and 94.4% sensitivity for early-stage cervical cancer, both at 90% specificity.
“This is what makes the data so exciting and meaningful,” says Abby McElhinny, chief scientific officer of AOA Dx, in a release. “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.”
The company is currently assessing its platform in tumor types outside gynecologic oncology, where preliminary evaluations indicate positive detection signals. Additional findings are scheduled for presentation at upcoming scientific meetings.
