Innovation Pipeline
One Technology. A Growing Pipeline of Precision Diagnostics.
Epi One’s proprietary technology provides a powerful foundation for discovering and developing molecular biomarker panels across multiple cancer indications. By identifying disease-specific molecular signatures, our platform enables a growing pipeline of innovative diagnostic solutions designed to address critical unmet clinical needs.
Prostate Cancer Tissue Reflex Test
Leading Product
Seeing Beyond Histopathology. Addressing MRI–Biopsy Discordance.
Epi One is developing a tissue-based epigenetic reflex test to address a critical diagnostic blind spot: highly suspicious prostate MRI findings (PI-RADS 4/5) followed by benign or atypical biopsy results. By detecting cancer-associated molecular signatures beyond conventional histopathology, the test aims to provide additional diagnostic insight and support more informed clinical decisions.
Prostate Preclinical Validation
Average AUC 0.95 | Sensitivity 96% | Specifity 90% PCR-based test in 299 tissue samples
Lung Cancer Nodule Triage Test
Expanding Pipeline
Beyond Imaging. Bringing Molecular Clarity to Lung Nodule Assessment.
Epi One is developing a blood-based epigenetic test to address a critical challenge in lung cancer detection: distinguishing potentially malignant pulmonary nodules from benign findings. By detecting cancer-associated epigenetic signatures in circulating cell-free DNA (cfDNA), the test aims to enhance risk stratification, complement CT imaging, and support more informed clinical decisions regarding surveillance or further diagnostic evaluation.
Lung Preclinical Validation
Average AUC 0.9 | Sensitivity 95% | Specifity 96% PCR-based test in 252 tissue samples
Multi-Cancer Test
Expanding Pipeline
One Molecular Platform. Multiple Cancers. Earlier Diagnostic Insight.
Epi One is advancing a PCR-based epigenetic biomarker panel designed to detect cancer-associated molecular signatures across multiple cancer types. Focused on high-risk and symptomatic populations, the test aims to support earlier cancer evaluation, improve diagnostic risk assessment, and guide timely clinical follow-up.
Multi-Cancer Tissue-Based Preclinical Validation
Average AUC 0.8 | Sensitivity 90% | Specifity 89% PCR-based test in 1432 tissue samples across eight solid tumor types
Multi-Cancer Blood-Based Preclinical Validation
Average AUC 0.84 | Sensitivity 62% | Specifity 100% PCR-based test in 113 blood samples