Oncocyte(US:OCX)2019-01-29 19:36OncoCyte 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]