Oncocyte Corporation announced the publication of data showcasing the clinical utility of its DetermaCNI™ blood-based monitoring test in the peer-reviewed journal Cancers. Oncocyte's DetermaCNI is a test used to measure and monitor cancer treatment success by detecting changes in circulating tumor DNA (ctDNA) levels, a minimally-invasive biomarker, during the course of treatment. The test is differentiated from other currently used methods because it does not require an upfront tissue sample, which can be hard to obtain, and also provides a genome-wide assessment as opposed to evaluating a subset of genes.

The test converts cell-free DNA (cfDNA) next-generation sequencing (NGS) results into a proprietary genome-wide copy number instability (CNI) score which can be used to guide ongoing treatment decisions. Results in this peer-reviewed publication demonstrated that DetermaCNI has the potential to address a significant unmet need for patients with primary epithelial ovarian cancer, which is the leading cause of death in gynecological cancers in Western countries. One of the goals of the study was to evaluate the role of the CNI score in monitoring patients' response to treatment, commonly platinum-based adjuvant chemotherapy following surgery.

Specifically, blood samples were prospectively collected from 109 patients with high-grade ovarian cancer. cfDNA was extracted and analyzed from the blood plasma to determine the genome-wide CNI score after whole-genome NGS. DetermaCNI detected ovarian cancer at diagnosis with 91% sensitivity and in patients at recurrence on treatment with 86% sensitivity, with a very low false positive rate of 5% (95% specificity).

These study results suggest the test has the potential to impact treatment change at crucial points for patients with ovarian cancer.