Denver, CO, June 1, 2026: AOA Dx announced new data at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting showing its AKRIVIS GD™ multi-omic blood test achieved 92% sensitivity for early-stage ovarian cancer detection in symptomatic women, nearly double the sensitivity historically associated with CA-125, the current standard biomarker for ovarian cancer detection.

Pioneering a New Biomarker Class in Cancer Detection

The findings mark a major milestone in cancer diagnostics: the first successful translation of lipid-based biomarkers into a clinically deployable cancer detection assay. While cancer diagnostics over the last decade have been dominated by genomics and circulating tumor DNA, AOA Dx is pioneering an entirely new biomarker class with the potential to reshape how cancer is detected across oncology.

Lipid metabolism, long studied primarily in cardiovascular disease and metabolic disorders, is increasingly recognized as a core driver of malignancy. Tumors and their surrounding microenvironment undergo profound metabolic reprogramming, and lipids are involved across multiple hallmarks of cancer, including tumor signaling, membrane remodeling, inflammation, and immune evasion.  Pairing specific lipid and protein biomarker alterations in ovarian cancer together with machine learning creates a powerful diagnostic for early detection.

Moving Beyond Single-Marker Diagnostics

No single biological layer tells the complete story of cancer. By integrating lipid, protein, and metabolite signatures with machine learning, AOA Dx has built a multi-omic discovery engine designed to capture the complexity of disease progression, creating a platform with applications that extend far beyond a single cancer indication. Through biomarker discovery across more than 2,200 unique patient samples spanning multiple sources and diverse demographics, the company is translating that engine into targeted, clinical-grade assays tested in real-world patient populations, with ovarian cancer serving as its first indication advancing toward early access launch.

The ASCO data build upon the company’s previously published peer-reviewed research and validate that lipid, metabolite, and protein biomarker signatures can successfully translate from discovery science into a targeted clinical-grade assay designed for real-world patient care.

“This is the moment where our science becomes a product. We have taken multi-omics, lipidomics, metabolomics, and proteomics out of the research setting and demonstrated that the targeted technology performs consistently in the exact population where this test will be used. A 92% early-stage sensitivity, compared to approximately 50% with CA125, tells us our multi-omic feature set is capturing pathways fundamental to tumor biology that single-marker approaches simply miss. This marks a fundamental milestone as we move into the next phase of validation and toward commercial launch.” said Oriana Papin-Zoghbi, CEO of AOA Dx.

Addressing One of the Biggest Gaps in Women’s Health

Ovarian cancer remains one of the deadliest cancers because it is rarely detected early. More than 90% of women survive when diagnosed at Stage I, yet nearly 80% are diagnosed too late. Most patients initially present with symptoms, but those symptoms are often vague, nonspecific, and difficult to interpret, while existing diagnostic tools lack the sensitivity needed to confidently rule out disease at the earliest stages. On average, it takes 9 months from first symptom to diagnosis.

AKRIVIS GD™ was specifically designed to address that gap. The non-invasive blood test combines lipid, metabolite, and protein biomarkers with machine learning to detect the complex biological changes associated with ovarian cancer earlier in the diagnostic pathway.

“Ovarian cancer is the one gynecologic condition that keeps us up at night. Our top priority is ruling it out as early as possible. A high-sensitivity test would be invaluable in this population,” said Dr. Kevin Elias, Gynecologic Oncologist and Principal Investigator, for the AOA Dx OVERT Clinical Study, Cleveland Clinic.

Strong Performance in the Intended Real-World Patient Population

The data presented at ASCO include patients from a prospectively recruited, multi-site, U.S.-based clinical study reflecting the intended use population:

• • 92% sensitivity in early-stage (Stage I/II) ovarian cancer
  • 96.5% sensitivity and 80.6% specificity for ovarian cancer detection in symptomatic women
  • Consistent performance across independent cohorts, reinforcing the robustness of the model

“What makes these results meaningful is not just the performance metrics,  it’s what they inform about the biology. We observe reproducible signals across lipid, metabolite, and protein features in a prospective, real-world patient population. That consistency reflects the fact that our multi-omic feature set is capturing fundamental aspects of the ovarian cancer tumor microenvironment, translating from our research datasets into the clinic. The fact that immunoassays and Mass Spectrometry are routinely used in high-throughput testing laboratories today for multiple applications means that AOA can quickly scale the test for broad adoption to impact patient care.” said Abigail McElhinny, PhD, Chief Scientific Officer, AOA Dx

From Scientific Discovery to Clinical Deployment

AOA Dx is now advancing AKRIVIS GD™ toward early access launch, positioning the company at the forefront of a new era in multi-omic cancer diagnostics. Leading that effort is a seasoned team of industry leaders including Chris Roberts, Chief Product Officer, bringing deep expertise in scaling diagnostic platforms from development to commercialization, and Cory Bystrom, PhD, Senior Director of Biomarker and Analytical Development, with a proven track record translating LC-MS diagnostics from discovery through clinical deployment. 

Together, they represent AOA Dx’s deliberate investment in the scientific, operational, and product leadership required to bring a first-of-its-kind multi-omic diagnostic to the women who need it most.

About AOA Dx

AOA Dx is transforming early cancer detection with its proprietary platform, a first-of-its-kind, multi-omics liquid biopsy that integrates lipids, metabolites, proteins and clinical data using advanced machine learning. The company’s lead test, AKRIVIS GD™, is designed to detect ovarian cancer early in symptomatic women, addressing a critical diagnostic gap in one of the deadliest cancers affecting women.

Based in Denver, Colorado, AOA Dx is led by an experienced team of scientists and industry veterans. The lab specializes in multi-omics analysis across lipidomics, metabolomics, and proteomics, powered by high-resolution mass spectrometry. By converting discovery-level data into validated, targeted assays, the platform enables repeatable, clinically scalable diagnostics with strong IP and regulatory pathways.

Media Contact:
Ariel Kramer
Klover Communications
ariel@klovercommunications.com