OncoDxRx Reached Key Milestone by Achieving High Accuracy of Its Multi-Cancer Early Detection Test

OncoDxRx's multi-cancer early detection technology demonstrated high accuracy. End Quote

(1888PressRelease) January 09, 2023 - Los Angeles, California - The milestone to improving the clinical outcome in cancer patients is the urgently unmet need to detect the disease at its earliest possible stage, which translates into a survival benefit for the patients. De-regulation of DNA methylation is an early event in tumorigenesis. OncoDxRx, a patient-centered and innovation-driven liquid biopsy company, has identified and validated differentially methylated DNA biomarkers at single CpG resolution for multiple cancer early detection and diagnosis.

When combined into a single methylation signature for in silico validation via TCGA (The Cancer Genome Atlas) database which consists of approx. 1500 samples across 14 major cancer types, the company’s 10-CpG panel yielded an outstanding accuracy of 0.895 (AUC value; area under the ROC curve). This data means there is an overall 89.5% chance that the panel will be able to distinguish between cancer and cancer-free subjects for all 14 cancer types.

“The higher the AUC, the better the model is at distinguishing between cancer patients and cancer-free subjects. When AUC is 0.5, it means the biomarker has no differentiation capacity whatsoever. Our 10-CpG methylation panel displayed AUC of 0.86 - 0.97 among individual cancer types; this means there is 86% - 97% chance that the panel will be able to distinguish between cancer and cancer-free cases for each indicated cancer. This is a huge accomplishment and key milestone for us.” The company explained.

The outstanding performance of logistic regression model on training and validation datasets demonstrated the robustness and accuracy of OncoDxRx’s 10-CpG classifier to effectively differentiate early-stage tumor from the normal tissues, underscoring their individual and collective potential as high-value biomarkers for early pan-cancer detection.

“Since the number of loci that could be assessed for methylation by locus-specific assays was narrowed down to 10 CpG, the use of these assays afforded the necessary sensitivity to detect the low copy numbers of methylated alleles that might have otherwise gone undetected using less-sensitive genome-wide analysis techniques.” The company noted.

OncoDxRx’s cancer early detection technology can be used to differentiate cancer patients from healthy subjects for high-risk population screening and surveillance, and thus to detect cancer earlier for preventive cancer management. According to the company, this breakthrough transformative discovery could deliver cheaper and faster results, well positioning OncoDxRx’s assay for large population screening purpose.

“The current standard of care used in cancer prevention programs, such as serum tumor markers, radiologic procedures, and endoscopic examinations, all have major drawbacks - limited sensitivity and specificity, invasiveness, high-cost, and patient compliance. Those patients who have molecular but not yet all the typical pathologic or radioscopic features associated with early-stage malignancy will be largely missed. The unprecedented potential of our technology for early detection of multiple cancer types based on specific CpG site methylation status will impact the cancer preventive medicine profoundly.” The company concluded.

OncoDxRx is actively seeking investors and partners to further validate this technology in clinical settings.

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