OncoCyte Corporation Conference Call Summary Company Overview - **Company**: OncoCyte Corporation (NASDAQ: OCX) - **Focus**: Development of DetermaVu, a novel liquid biopsy lung cancer diagnostic test Key Industry Insights - **Lung Cancer Statistics**: Approximately 234,000 new cases and 154,000 deaths in the U.S. annually, highlighting the need for early detection [doc id='22'] - **Market Opportunity**: Estimated annual total addressable market of up to $4.7 billion in the U.S. for lung cancer diagnostics [doc id='25'] Core Findings from R&D Validation Study 1. **Test Performance**: DetermaVu demonstrated a sensitivity of 90% and specificity of 75% in a blinded study of 250 patient samples [doc id='9'][doc id='11] - **Confidence Intervals**: Sensitivity 95% CI: 82%-95%, Specificity 95% CI: 68%-81% [doc id='11'] - **Impact on Biopsies**: With 75% specificity, DetermaVu could eliminate up to 75% of unnecessary biopsies, potentially saving the healthcare system billions annually [doc id='11'] 2. **Innovative Approach**: Achieved results without including clinical data in the algorithm, a first in oncology diagnostics [doc id='9'][doc id='14'] - **Biological Basis**: Utilizes immune system responses to detect cancer, representing a breakthrough in cancer diagnostics [doc id='12'][doc id='19'] 3. **Future Applications**: The methodology has potential applications across other cancer types, expanding the scope of DetermaVu beyond lung cancer [doc id='15'][doc id='19'] Commercialization Plans - **Launch Timeline**: Targeting commercialization in the second half of 2019 [doc id='13'] - **Pricing Strategy**: Expected pricing between $3,000 to $4,000 per test, significantly lower than the average lung biopsy cost of $15,000 [doc id='51'] - **Sales Strategy**: Focused marketing to approximately 6,000 pulmonologists in the U.S. with a small, targeted sales force [doc id='52] Clinical Validation Steps - **Next Studies**: Plans for analytical validation, CLIA lab transfer validation, and clinical validation involving approximately 350 patients [doc id='20'][doc id='38] - **Expected Outcomes**: Anticipated results to fall within established confidence intervals, confirming the test's viability [doc id='38'] Additional Insights - **Complication Rates**: A recent JAMA study indicated a complication rate of 22%-24% from lung biopsies, underscoring the need for DetermaVu [doc id='24'] - **Payer Engagement**: Positive feedback from 10 public and commercial health plans covering 77 million lives, recognizing the unmet medical need addressed by DetermaVu [doc id='26] Conclusion - **Significant Breakthrough**: DetermaVu represents a potential standard in lung cancer screening and detection, with implications for broader cancer diagnostics [doc id='27] - **Future Updates**: OncoCyte plans to provide further updates on progress and financial results in upcoming calls [doc id='74]