DENVER — When Ingrid Kolstoe began experiencing vague abdominal discomfort a few years ago, she chalked it up to routine gastrointestinal issues. The 52-year-old Denver resident had no way of knowing the peculiar pains were among the earliest whispers of an ovarian cancer that had already spread widely through her body by the time it was detected.
“Ovarian cancer has traditionally been called a silent killer because it really whispers,” said Ms. Kolstoe, who was devastated to receive a stage 4 diagnosis in 2021. “In the beginning, the symptoms are very subtle. Many women are just told they have IBS.”
Her poignant lament underscores a sobering reality: There are currently no approved screening methods to catch ovarian cancer early, before it becomes an aggressive, late-stage disease with bleak survival prospects. But a pioneering Denver biotech startup aims to change that, striving to develop the world’s first diagnostic blood test for early ovarian cancer detection—a potential breakthrough that could transform a notoriously lethal malignancy into one of the most preventable cancers.
The company, AOA Diagnostics, has received millions in funding and assembled a team of top scientists at a new laboratory in Denver’s RiNo district. Their goal is to create a simple blood test that can detect ovarian cancer at its earliest stages with high accuracy, when curative treatment is still possible.
“We’re starting in ovarian cancer because there’s a huge, unmet need there,” said Oriana Papin-Zoghbi, AOA’s co-founder and chief executive, “and because our early research indicates we could have scientific success there as well. But the goal is to take this technology and really apply it to a number of different cancers that affect women.”
Only about 20 percent of ovarian cancers are currently caught before the disease has spread beyond the ovaries, according to the American Cancer Society. With no effective screening tool, ovarian cancer often goes undetected until it has reached an advanced stage, dramatically reducing the chances of survival. The shortage of early detection methods stems from the cancer’s insidious biology—it initially causes only vague symptoms like bloating or abdominal discomfort that are easily overlooked.
AOA is taking a new approach to cancer diagnostics, developing technology to isolate and analyze tiny biomarkers called exosomes that are released by ovarian tumors and circulate in the bloodstream. The company’s investigational test aims to detect the molecular fingerprints of cancer-linked exosomes at extremely low levels with high sensitivity, well before any outward signs or symptoms appear.
“There’s a lot of steps to get there, and that’s the work we’re doing,” Ms. Papin-Zoghbi said of the long path from academic research to a clinically-validated diagnostic test. “When we started AOA, it was really on that passion of making a difference, of transforming women’s health, of doing something to actually not just complain about how bad it is but make a difference in how good it could be.”
Despite a recent surge in Colorado’s biotechnology sector, few companies have tackled the challenge of ovarian cancer screening head-on. The disease has long been regarded as an intractable diagnostic target due to the ultra-low levels of tumor biomarkers found in the blood during early stages. But more advanced molecular technologies are now allowing scientists to detect increasingly faint cancer signals from precise biomarkers like exosomes.
“We are in the heart of innovation right now,” said Ms. Papin-Zoghbi. “That innovation is happening right here, and AOA is definitely pushing the boundaries.”
The company’s investigational test analyzes both tumor-derived exosomal proteins and nucleic acids like RNA and DNA, allowing the test to potentially detect multiple cancer signals from a single blood sample. While early research has been encouraging, the exosome-based screening approach still requires rigorous validation before it could be considered for regulatory approval and widespread clinical use.
AOA has initiated a prospective clinical trial of its test, called OVERT, to evaluate its performance for detecting ovarian cancer at different disease stages. The trial aims to enroll thousands of participants at clinical sites across the United States.
“Ovarian cancer is such a devastating disease, so a tool for early detection would be game changing,” said Dr. Saketh Guntupalli, a gynecologic oncologist at the University of Colorado Anschutz Medical Campus who is assisting with the trial. “If we can catch ovarian cancers earlier, we can dramatically improve survival rates.”
