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Game changing facility in Cancer Diagnostics and Treatment now available at RGCI & RC in collaboration with Star Health Network and associated partners (THOMAS JEFFERSON UNIVERSITY - KIMMEL CANCER CENTER & YALE SCHOOL OF MEDICINE )
Precipio DiagnosticsPrecipio \pri-sip-E-O\ verb (Latin): 1. to anticipate 2. to advise Yale Tumor Profiling Training Session - Private & Confidential -
Agenda • Our Vision • Targeted Customers • Tumor Profiling • Case study • Background & Philosophy of the Tumor Profile lab and Dr. Sklar, Founder/Medical Director • Molecular Diagnostic testing • Current alternatives/Competition • Tumor Profile Technical specifications • The Report • Key competitive advantage elements • Competitive analysis, advantages & differentiations • Requisition & Logistics • Billing - Private & Confidential -
Our Vision Create the highest standard of diagnostic quality by harnessing academic intellect, expertise, and technology, and delivering it to benefit the patient - Private & Confidential -
Targeted Customers • Community-based oncologists • Hospitals (pathologists supporting the oncologists for molecular testing) • Reference Laboratories • Surgical Centers - Private & Confidential -
Case study • 73-year old female patient in Memphis, TN • Diagnosed with Lung Cancer, estimated 6 months left • Underwent two failed chemotherapy treatment courses • Precipio sales executive visited the treating oncologist • Yale Tumor Profiling lab introduced • Oncologist agreed to try the test, Patient biopsy sent to Precipio for diagnosis • Yale Tumor profiling panel conducted on patient specimen • An actionable mutation was found • Patient put on new treatment course that would otherwise not have been considered • Patient now anticipated to have another 1-3 years Treating physician: Dr. Gregory Franz Practice: Boston Baskin Cancer Center, Memphis, TN Date of report: March 27, 2012 - Private & Confidential -
MDx testing – current options • Once patient tumor diagnosed with cancer (surgical pathology performed), MDx ordered to identify specific treatments • E.g. – EGFR for lung cancer – positive diagnosis responsiveness to erlotinib • Oncologist/pathologist sends the tissue to outside MDx lab • Economics of PCR MDx cause batching TAT of 10-14 days. • Commercial high-throughput labs have high level of QNS (~25%) • Individual gene testing: • Economic • Focused • Pathologists are comfortable with this • Pinpoint vs. comprehensive • Repeat ordering • Reliant on physician current knowledge • Time/cost/tissue inefficient • Yale TP: • Comprehensive and updated • Actionable-only information • Time/cost/tissue efficient • NGS testing: • Most advanced technology • Scalable and comprehensive • Forward-looking • Information overload • Non-actionable information • High bill • Potential legal liability - Private & Confidential -
Background & Philosophy of Tumor Profile Lab • Oncologists want results that drive treatment • Practical, easy-to-read report with pertinent information • Affordable and responsible costs • Jeff Sklar, MD, PhD • Director of Molecular Diagnostics at Yale • Chief Scientific Officer at Precipio • Trained at Harvard, Stanford, Yale • Pioneer in the field of diagnostics • Discovered the Immunoglobulin Gene Rearrangement (B-Cell Lymphomas) • The inherent conflict of personalized medicine: • “If you don’t go looking in unexpected places, you’ll never find it” - Private & Confidential -
Tumor Profile Technical Specifications • Platform – Taqman Array • Closed environment to reduce contamination • Higher level of accuracy • Cost Effective (No Batching) • Genes tested • More mutations examined per gene than conventional PCR • Stage & Reflex approach • Genes mutually exclusive • Start with most prevalent, continue to rarer mutations • Laser Capture Micro-dissection • Extract tumor cells from tissue • Performed by Yale trained MD, PhD (Dr. Walther) • Allows for processing of virtually any type of sample submitted - Private & Confidential -
Tumor Profile Report • Clear, actionable diagnosis • Personalized reporting • Responsive/Non responsive Treatment alternatives • Relevant clinical trials • 3 pages - Private & Confidential -
Key competitive advantages • Actionable diagnosis • Literature-supported actionable mutation analysis • Tumor-tailored panels • Comprehensive mutation-testing panels • Continuously updated • Staged / Reflex approach • Responsible billing • Stage/reflex reduces insurance bills • Testing & Reporting ONLY of actionable genes • Approved by Medicare & private payers • Rapid Turnaround time – 7-10 days • Tissues accepted • All tissue forms • Minimal tissue quantities required • No QNS !! - Private & Confidential -
Comparative Analysis - Private & Confidential -
Tumor Profile Requisition and Logistics Requisition form - 3 sections: • Physician & patient information • Test selection • Comprehensive (Omnia) – Yale pathologist will determine the correct panel • Specific tumor-type test • Comprehensive for that tumor • Specific genes relevant to that tumor • Pathology • Customer/office to provide contact info where biopsy is located • Important: Sales person should introduce Precipio to the pathology group • Precipio will material-request the biopsy directly – avoiding office handling • Logistics: • Materials sent to Precipio • 7-10 day TAT - Private & Confidential -
Marketing materials • Requisition form • Sample report • TP Overview (silhouette) • TP vs. standard molecular • TP flow chart for NSCLC & CRC • Case studies (coming soon) • Additional materials: • The Cancer Journal Article authored by Jeff Sklar & Zenta Walther • TP introduction package (15-page PDF intro) • Technical validation package (152-page technical info package) - Private & Confidential -