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 )
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Yale Tumor Profiling
Training Session
Precipio Diagnostics
Precipio \pri-sip-E-O\ verb (Latin): 1. to anticipate 2. to advise
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Agenda
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Our Vision
Targeted Customers
Tumor Profiling
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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
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Our Vision
Create the highest standard of diagnostic quality by harnessing
academic intellect, expertise, and technology, and
delivering it to benefit the patient
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Targeted Customers
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Community-based oncologists
Hospitals (pathologists supporting the oncologists for molecular testing)
Reference Laboratories
Surgical Centers
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Case study
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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
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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:
Yale TP:
NGS testing:
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 Comprehensive and updated
 Actionable-only information
 Time/cost/tissue efficient
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Economic
Focused
Pathologists are comfortable with this
Pinpoint vs. comprehensive
Repeat ordering
Reliant on physician current knowledge
Time/cost/tissue inefficient
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Most advanced technology
Scalable and comprehensive
Forward-looking
Information overload
Non-actionable information
High bill
Potential legal liability
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Background & Philosophy of Tumor Profile Lab
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Oncologists want results that drive treatment
Practical, easy-to-read report with pertinent information
Affordable and responsible costs
Jeff Sklar, MD, PhD
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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”
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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
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Tumor Profile Report
• Clear, actionable diagnosis
• Personalized reporting
– Responsive/Non responsive Treatment alternatives
– Relevant clinical trials
• 3 pages
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Key competitive advantages
1. Actionable diagnosis
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Literature-supported actionable mutation analysis
2. Tumor-tailored panels
– Comprehensive mutation-testing panels
– Continuously updated
– Staged / Reflex approach
3. Responsible billing
– Stage/reflex reduces insurance bills
– Testing & Reporting ONLY of actionable genes
– Approved by Medicare & private payers
4. Rapid Turnaround time – 7-10 days
5. Tissues accepted
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All tissue forms
Minimal tissue quantities required
No QNS !!
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Comparative Analysis
Factor
Yale TP
Competition
Genes selected
Actionable only
Insufficient/overkill
Mutations run
All known mutations, updated
Limited, lagging
TAT
7-10 days max
10-14 days minimum
Billing
- Responsible/minimal, controlled
thru Stage/Reflex
- Approved by Medicare/Private
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Tissues tested
- All tissues
- Minimal quantities
- Usually FFPE only
- 25% QNS
Personalized
Relevant drugs & Clinical trials
Relevant drugs
Hassle factor
- Low – Physician can order
comprehensive without
specifying genes
- PDX requests tissue from Path
- High – Physician needs to specify
order, remain “on top” of
discoveries
- Practice needs to request tissue
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MDX Cheaper than TP
TP cheaper than NGS
Risk of patient bill
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Tumor Profile Requisition and Logistics
Requisition form - 3 sections:
1. Physician & patient information
2. 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
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Pathology
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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:
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Materials sent to Precipio
7-10 day TAT
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Marketing materials
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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)
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