Defining the Future of Rapid and Sensitive Diagnostic Tests

Transcription

1 Defining the Future of Rapid and Sensitive Diagnostic Tests Dr. Byron Shen, CEO

2 2 Catching the Waves at the (UCI) Cove

3 TechPortal - the Portal to Entrepreneurship TechPortal is designed to help UCI scientists to turn their great ideas into real business Affordable incubator space that provides legitimacy, visibility, & networking opportunity Business & technical resources CADMIM & Microfabrication Committee members & Industry Advisory Group Great student interns 3

4 A Simple Question in Diagnostic Applications Can a diagnostic technology achieve great sensitivity and rapid speed in combination? 4 Velox stands for velocity

5 IC3D Droplet Digital Detection Exceptional Sensitivity Rapid Speed Sample 5

6 6 Finding your Needle in a Haystack (or Where s Waldo?)

7 Microfluidic Droplet Generation Raw Sample Fluorescent Chemistry Reagents 7 Oil Target-containing Droplet Oil We have strong expertise in microfluidics

8 3D Droplet Counter Pattern Recognition Algorithm AD Converter Acquisi0on Card Laser 1 Laser 2 PMT 2 F ex F ex F em PMT 1 Milliliters of Droplet Solution L1 D1 D2 L2 PH L3 D3 Throughput: 100 pl in 0.01ms (or 1 ml in 100 s; 100s millions of droplets/min) Robustness: Near-zero false positive and negative counting rate F em 8 We can detect one positive droplet out of one billion droplets

9 Major Applications & Business Opportunities Bloodstream Infection (BSI) Rapid S2A High level clinically actionable information Liquid Biopsy Noninvasive (from blood or plasma) Exceptional sensitivity Faster Urinary Tract Infection (UTI) POC application Rapid detection AST And other partnership projects with leading global pharma and diagnostics companies 9

10 Building the Velox Core Team Byron Shen, PhD CEO Tim Abram, PhD Director, R&D Part time/consultants Chenyin Ou, PhD Senior Scientist Mel Toosky, PhD Senior Scientist Mark Go Lab Tech Weian Zhao, PhD Sci. Advisor UCI Zhao Lab John Grunwald RA M. McKeown Market Research Mark Kelly fractional CFO Natalie Kennel Regulatory/Quality EXPERTISE at Velox: Microbiology Molecular biology Immunology Cancer biology Chemistry Microfluidics Instrumentation Finance Marketing Regulatory UCI RESOURCES: Zhao Lab Laboratory of Fluorescence Dynamics Microfab lab 10

11 11 New Lab and Office in Irvine

12 Company Status and Plan $8M $6M $4M $2M Feasibility Product Development Clinical / FDA $60K F & F $1M Seed #1 $2M Seed # $7.5M Series A Pre-Seed Milestones ü Demonstrate Lab Bench Prototype POC ü IP filed ü Hire BizDev and Marketing Executives ü Secure Seed Funding ($1M) Seed Round Milestones ü Complete Market Opportunity Assessment ü Demonstrate Product/Clinical POC ü Set up the Velox lab Instrumentation prototyping/assay development Secure Series A Funding (H1 2018) Series A Milestones 1) Expand team & operation (U.S. and China) 2) Complete product development (Q2 2018) 3) Commence clinical trials (H2 2018) (U.S. or China) 12 Also UCI partnership and $5M NIH grant for technology development

13 Velox - Making Waves 2017 Octane Hi Tech Innovation Award - Finalist Dr. Heylman received the prestigious UC Entrepreneur Award Cove Currents Feature Article 2016 Los Angeles Business Journal Patrick Soon-Shiong Innovation Awards Nominee UCI TEDx Talk (Dr. Weian Zhao) Calit2 Interface Magazine Feature Article Click on links for more info Key Milestones R Sepsis/AST product and clinical POC demonstrated R Liquid biopsy proof-of-concept demonstrated R Velox lab is set up and fully operational. Active instrumentation and assay development R&D in progress R Several partnership projects with top diagnostics/life sciences companies in progress 13

14 Individually we are one drop. But together, we are an ocean. Thank you! Dr. Byron Shen, CEO (949)

15 Integrated Comprehensive Droplet Digital Detection (IC3D) - animation

16 The IC3D Advantages - Summary Sensitivity 1 target/ml Speed Sample to Answer (S2A) 1-4 hours Minimal Processing Uses raw sample Culture-free No loss of targets Platform Technology Any fluorescent chemistry Plug & play Broad applicability 16 IC3D can find a needle in a haystack quickly and accurately

17 Key Clinical Application BSI/Sepsis Blood culture takes too long " IC3D: S2A 1 2 hrs 2-14 days for results E. coli in whole blood 17 IC3D = raid speed + exceptional sensitivity

18 Key Clinical Application Liquid Biopsy Current Modality - potential loss of sensitivity " Exceptional Sensitivity w/ IC3D Enrichment Extraction Isolation Amplification or Sequencing Multiple processing steps Let-7a mirna in plasma 18 IC3D = raid speed + exceptional sensitivity

19 IC3D for Rapid Detection of BSI and Sepsis Create Droplets 1 ml in 10 min Raw Unprocessed Sample POSITIVE NEGATIVE Incubation / Chemistry 35 min Count Fluorescent Droplets 1 billion droplets in 10 min Accurate to 1 target per ml 1 droplet per 1 billion 19 S2A in 1-3 hours and Single Target Sensitivity

20 Rapid Blood Stream Infection Diagnostics (U.S. Market) Sepsis costs > $24B to treat annually in the U.S. Mean cost per ICU stay: $40K 1500 ICU patients / day with suspected BSI CDC and NIH, 750,000-1,000,000 Blood Stream Infections (BSI) annually in the U.S. 1,2 Typical US hospital has 4-12% true-positive culture rate for blood infection diagnoses 3,4,5,6 Approximately 16 Million blood cultures ordered annually in the US for suspected infections (not including therapy monitoring) $150/test: TAM of $2.4B per year in the U.S. [1] Angus DC, Linde-Zwirble WT, Lidicker J, et al. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med 2001;29: [2] National Center for Health Statistics Data Brief No. 62 June Inpatient care for septicemia or sepsis: a challenge for patients and hospitals [3]Nathan I. Shapiro, MD, MPH; Richard E. Wolfe, MD, et al. Who Needs a Blood Culture? A Prospective Derived and Validated Prediction Rule J Emerg Med. 2008;35(3): [4]Roth A,Wiklund AE, Pa lsson AS, et al. Reducing blood culture contamination by a simple informational intervention. J Clin Microbiol. 2010;48(12): [5]Hall, K. K., & Lyman, J. A. (2006). Updated Review of Blood Culture Contamination, 19(4), [6]Coburn, B., & Morris, A. M. (2012). CLINICIAN S CORNER Does This Adult Patient With Suspected Bacteremia Require Blood Cultures? JAMA. 2012;308(5): doi: /jama [7]Khandelwal N, Benkeser D, Coe NB, et al.. Patterns of Cost for Patients Dying in the Intensive Care Unit and Implications for Cost Savings of Palliative Care Interventions. J Palliat Med Nov;19(11): Massive problem, huge opportunity

21 A Compelling Value Proposition Rapid diagnosis (1-3 hours) with clinically actionable info for sepsis/antibiotic resistance Early detection/confirmation of sepsis Gram (+)/Gram (-) ID & major antibiotic resistance panel Accurate quantification of bacteria load* *Quantification not available with current technologies Critical information at the most critical time window in the ED/ICU setting ü Rapid detection = targeted treatment sooner, better clinical outcome, and better antibiotics stewardship ü Physicians strongly support our value proposition: Market research survey with ED, ICU, ID doctors (n=35) 97% agree the Velox product would fill an unmet need 85% could see the Velox product becoming the standard of care 21

22 Velox vs Competition Velox 22 Current products don t meet clinical need for sensitivity and speed