Advancing                                      Personalized Medicine                                      one cancer patie...
Team of scientists and MBA students            James Lim, PhDScientist            Experience: Seven years of cancer cell m...
Circulating Tumor Cells (CTCs): Initial Idea Circulating tumor cells                      Oncologists & Pathologists      ...
Testing our initial hypotheses: Focus oncustomer segments and value propositions                                          ...
Get out of the Building! Talked to customers and        partners to test our hypotheses                          • Visited...
Key people we spoke to: Dr. Leisha Emens Dr. John Siebel Dr. Ana Aguilar Dr. Scott North Dr. George Sledge Dr. Alan Venook...
Determining our customers Oncologist              Pathologist Patient management      Sample management• Oncologists decid...
Key messages from Oncologists:Dr. Siebel “Culturing a patient’s CTCs to test efficacy of therapies would be valuable, if y...
What we learned from similar companies:                                 RNA Diagnostics                                  “...
The value proposition epiphany: CanScan is a           cell culture company!                                          10  ...
We are unique in our ability to culture CTCs                                                      Technology Capability   ...
Cell culture value proposition                      Identify and                    enumerate CTCs  Characterizegrowth pot...
Updated business canvas                       Consultation                       Characterization        Provide new data ...
Alternative market model                                                         • Urged by the teaching team to          ...
Alternative market model              • Urged by the teaching team to                explore alternative markets          ...
Partnering with Quest Diagnostics                         • Covers 130 countries                         • 2000 sites in t...
Partnering with Quest Diagnostics                                    17                    17
Partnering with Quest Diagnostics                                    18                    18
Key people we spoke to: Dr. Ming Tong Dr. Brian Edmunds Dr. Philip Tagari Dr. Thomas Fare Dr. Sal Russelo Dr. Steve Labkof...
New opportunity: Pharmaceutical drug testing“A better human-like in vitro modelsfor high throughput screening”          He...
Pharmaceutical customer              Low Barrier to Entry              Quick Revenue                                     2...
Current business canvas                         Cell charact.                         Database dev.           Provide new ...
Intellectual property progress              Who owns            What is                   Patent                New IP    ...
Path to Revenues                 Mechanistic                    PoC  Concept      • Cell culture                 feasibili...
Path to Revenues                 Mechanistic        Technology                    PoC               Scope  Concept      • ...
Path to Revenues                 Mechanistic        Technology           Biomarker                    PoC               Sc...
Path to Revenues                 Mechanistic        Technology           Biomarker             Clinical                   ...
Financial / Operational Timeline                                2012                                       2013           ...
Financial / Operational Timeline                                2012                                        2013          ...
Financial / Operational Timeline                                2012                                                 2013 ...
Financial / Operational Timeline                                2012                                                 2013 ...
Choosing Partners: Decision Matrix LAB / Incubator Proof of Concept   COST   TIME   IP issues ?                           ...
Next Steps                                                                        FDA Clinical                            ...
Technology: Capture, Culture, Image CTCs                                     34                       34
Live cancer cells = Better prognostics?                                      35                       35
The CanScan Vision: Personalized DiagnosticsPlatform for:New drug testingPersonalizedChemosensitivitytestingBiomarkerDisco...
Thank you!James Lim, Ph.D., Nelson Chan, Ph.D., Dale Fedun, Brian FethMentor: John Feilders (CMEA Capital)Lawrence Berkele...
AppendixJames Lim, Ph.D., Nelson Chan, Ph.D., Dale Fedun, Brian FethMentor: John Feilders (CMEA Capital)Lawrence Berkeley ...
CanScan Technology: Background on CTCs                   Collection of cells that have the                   ability to ‘m...
Current CTC technologies: Limitations                  Competitors                 Marker-Dependent     Marker-           ...
Improving CTC detection and characterization        Invade                       Current detection and                    ...
CanScan Tech: substrates and imaging software                                          42                          42
Genomic Health: Historical Financials250          Profit200          Costs150          Revenues100 50  0 -50   2000       ...
Health insurance reimbursement is necessary        precondition for hospitals to use our service   Private insurance or Me...
CMS requires that all laboratory testing on human            specimens be CLIA certified   • CMS regulates all laboratory ...
The market size for metastatic cancer diagnostics in   the US is estimated to be $805 Million / year Methodology:         ...
Technology: Capture and Culture CTCs             1. Draw blood                  2. Separate blood through centrifugation3....
Technology: Enrichment and Selection               Detailed comparison of               CTCs from a single patient        ...
Upcoming SlideShare
Loading in …5
×

Can scan final 2012 berkeley

1,242 views

Published on

0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total views
1,242
On SlideShare
0
From Embeds
0
Number of Embeds
2
Actions
Shares
0
Downloads
26
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide
  • Our team has a depth of scientific and business experience in our core markets
  • We initially believed we were a visualization company with a novel approach to characterizing cancer Create value by enumerating and characterizing the aggressiveness of CTCsTarget customers in hospital (i.e., pathologist, oncologist, patients) Use a CLIA-based service model to deliver value to customersUse direct sales channels to reach customers in the hospital
  • When we entered the class, we thought our target markets were physicians managing clinical trials, pathologists (traditionally the main cancer diagnostician at a hospital), oncologists, and patients. And we were fairly certain the patients might be interested in purchasing kits to look for cancer recurrence.
  • Interview summary slideShowwe had discussions with oncologists and competitors from these institutions(see mammoptics slide 10)
  • What oncologists do, what pathologists do. Focus on oncologists.Need a new approach to get interviews with oncologists. Hit the rolodex, plan interviews far in advance, daisy-chain to new contactsPathologists do not order tests, and usually don’t decide where to source a test from, so are less important to our business
  • key learnings from oncologists (value proposition)
  • Title and company for “quotes”
  • Leading up to this slide, we need to be developing the case for a pivot into a cell culture company. John didn’t seem clear on how/why we decided this.
  • Change technology column to: Dead vs live cellsThe point of this slide is simply that right now culturing is a unique proposition. Do not focus on all competitors or what they do or how we will compete. Make the simple point of for now we have a unique proposition.
  • Value Proposition of Cell CulturingCell culture node in the middleBubbles appearing around showing value prop of cell culturingSimilar to mammoptics slide 19
  • This is about "reimbursement“. Use our original slide, then on the next slide overlay “start-ups can die while waiting for a CPT code"(mammoptics slides 11&12)The point here is CPT Code
  • This is about "reimbursement“. Use our original slide, then on the next slide overlay “start-ups can die while waiting for a CPT code"(mammoptics slides 11&12)The point here is CPT Code
  • To Do:Quest logo, map to show they are national-what Quest does-they would build it for us-10% of revenues
  • To Do:Quest logo, map to show they are national-what Quest does-they would build it for us-10% of revenues
  • To Do:Quest logo, map to show they are national-what Quest does-they would build it for us-10% of revenues
  • Interview summary slideShowwe had discussions with oncologists and competitors from these institutions(see mammoptics slide 10)
  • They are willing to purchase the CTCS. Also they are willing to outsource the service to us. _____________AnimationThis is the far better than our cancer cell modelsThis would be a powerful companion diagnostic tool to support personalized medicinesThis can improve personalized medicineCulture CTC is good, this can change how we developWe need it, this is whyNo regulation to serve usWe’ll pay for it when you can prove itSame format as previous bubble slides: pharma has a large unmet need for better human-like in vitro HTS models (quotes).
  • We need it, this is whyNo regulation to serve usWe’ll pay for it when you can prove itSame format as previous bubble slides: pharma has a large unmet need for better human-like in vitro HTS models (quotes).
  • Development timeline (milestones)graph of costs over time Similar to mammoptics slides 57 – 63 (but less busy)
  • Development timeline (milestones)graph of costs over time Similar to mammoptics slides 57 – 63 (but less busy)
  • Development timeline (milestones)graph of costs over time Similar to mammoptics slides 57 – 63 (but less busy)
  • Average clinical trial cost per patient is $6,000, which would imply $1.2M for a 200 patient trial. However, the cost of trials is a range that we think we’re on the low end of since it would be existing drugs used
  • Average clinical trial cost per patient is $6,000, which would imply $1.2M for a 200 patient trial. However, the cost of trials is a range that we think we’re on the low end of since it would be existing drugs used
  • Average clinical trial cost per patient is $6,000, which would imply $1.2M for a 200 patient trial. However, the cost of trials is a range that we think we’re on the low end of since it would be existing drugs used
  • Average clinical trial cost per patient is $6,000, which would imply $1.2M for a 200 patient trial. However, the cost of trials is a range that we think we’re on the low end of since it would be existing drugs used
  • Average clinical trial cost per patient is $6,000, which would imply $1.2M for a 200 patient trial. However, the cost of trials is a range that we think we’re on the low end of since it would be existing drugs used
  • Overview of failed trials – most recent, one FDA approved device / comprehensive overview of CTCs in the clinical setting. TRY TO FIND TRIALS FOR PEDIATRICS – this might be the first of its kind… / emphasize that.
  • Overview of failed trials – most recent, one FDA approved device / comprehensive overview of CTCs in the clinical setting. TRY TO FIND TRIALS FOR PEDIATRICS – this might be the first of its kind… / emphasize that.
  • Overview of failed trials – most recent, one FDA approved device / comprehensive overview of CTCs in the clinical setting. TRY TO FIND TRIALS FOR PEDIATRICS – this might be the first of its kind… / emphasize that.
  • Historical significance, what are they, what are some of the unique attributes of these cells / cite tons of references
  • Marker/antibody based approaches have inherent limitationsLowsensitivity, specificity, and reproducibility.
  • Marker/antibody based approaches have inherent limitationsLowsensitivity, specificity, and reproducibility.
  • Overview of failed trials – most recent, one FDA approved device / comprehensive overview of CTCs in the clinical setting. TRY TO FIND TRIALS FOR PEDIATRICS – this might be the first of its kind… / emphasize that.
  • Average clinical trial cost per patient is $6,000, which would imply $1.2M for a 200 patient trial. However, the cost of trials is a range that we think we’re on the low end of since it would be existing drugs used
  • Overview of failed trials – most recent, one FDA approved device / comprehensive overview of CTCs in the clinical setting. TRY TO FIND TRIALS FOR PEDIATRICS – this might be the first of its kind… / emphasize that.
  • Overview of failed trials – most recent, one FDA approved device / comprehensive overview of CTCs in the clinical setting. TRY TO FIND TRIALS FOR PEDIATRICS – this might be the first of its kind… / emphasize that.
  • Can scan final 2012 berkeley

    1. Advancing Personalized Medicine one cancer patient at a time.James Lim, Ph.D., Nelson Chan, Ph.D., Dale Fedun, Brian FethMentor: John Feilders (CMEA Capital)Lawrence Berkeley National LaboratoryUniversity of California, Berkeley – Haas School of Business *73 interviews 1
    2. Team of scientists and MBA students James Lim, PhDScientist Experience: Seven years of cancer cell microscopy Expertise: Live-cell microscopy and cancer cell biology Dale Nelson James Brian Nelson Chan, PhDScientist Experience: Seven years of cancer research Expertise: Biochemical and toxicological analysis mediating cancer cell death Brian FethMBA Experience: Five years in life sciences business strategy consulting and private equity Expertise: Business model development and project management Dale FedunMBA Experience: Twelve years in creating and managing business IT programs Expertise: Business model and IT system development 2 2
    3. Circulating Tumor Cells (CTCs): Initial Idea Circulating tumor cells Oncologists & Pathologists Cancer cells that have Does my patient have any detached from the CTCs? tumor and are How aggressive are they? circulating in the blood stream Capture and grow CTCs Video technology to characterize aggressiveness 3 3
    4. Testing our initial hypotheses: Focus oncustomer segments and value propositions Diagnosis/ Direct salesAdvocacy Groups Consultation Prognosis: Conferences CliniciansRegulatory Cell- Cell validation MD office Adverts OncologistsAgency Characterization Patient mgmt Publications PathologistsOncologists Database building Drug selection Patient PatientsPhysicians Assoc Disposal advertisements R&D Minimally invasive Low cost Specific IP Fast Patient Database Hospital MD office, HMO Advocacy Groups PharmaVariable: Media, plastic ware, personnel, computing Service per time point (service/use)storage, building space Kits / Reagents (patients only)Fixed: Centrifuge, microscopes, freezers, incubators,and hoods 4 4
    5. Get out of the Building! Talked to customers and partners to test our hypotheses • Visited local hospitals and clinics • Called nurses and patients to get perspectives • Spoke with physician and patient advocacy groups • Hit the rolodex, plan interviews far in advance, daisy-chain to new contacts 5 5
    6. Key people we spoke to: Dr. Leisha Emens Dr. John Siebel Dr. Ana Aguilar Dr. Scott North Dr. George Sledge Dr. Alan Venook Dr. Peter Eisenberg Dr. Cassandra Lee Dr. Balaram Puligandla Dr. Ken Pritzker (CEO) Dr. Doug Tkachuk (CMO) Dr. Scott Minick (CEO) 6 6
    7. Determining our customers Oncologist Pathologist Patient management Sample management• Oncologists decide • Pathologists perform in- what tests to order, house tests and when, and how often facilitate contracts with service providers• Primary customer • Less important 7 7
    8. Key messages from Oncologists:Dr. Siebel “Culturing a patient’s CTCs to test efficacy of therapies would be valuable, if you could prove in vitro results are replicated in vivo.”Dr. Sledge “Don’t give us more data. Tell us which drug to use for each patient.”Dr. North “Definitively knowing if a patient should get chemo would be a major breakthrough in oncology.” 8 8
    9. What we learned from similar companies: RNA Diagnostics “The space is crowded; there are many start-ups enumerating CTCs”LifeLabs “The clinical setting is difficult and can take years to get to market” Bind Biosciences “CTC enumeration is not as useful and provides a limited sample. Your approach is unique and overcomes key limitations.” 9 9
    10. The value proposition epiphany: CanScan is a cell culture company! 10 10
    11. We are unique in our ability to culture CTCs Technology Capability Company Product Technology Channel Isolate Count Analyze Culture Parsortix Filter  Kits CellSearch Antibody  Kits Vita-Assays Substrate  Kits Mvs360 Antibody  Device OncoCEE Microfluidics   CLIA labs LiquidBiopsy Antibody   CLIA labs ISET device Filter   Device On-Q-ITY chip Microfluidics    Device ApoStreamTM Technology Microfluidics    Device - Substrate     CLIA? *This is an abbreviated list 11 11 Class 8 - Update 3.19.2012
    12. Cell culture value proposition Identify and enumerate CTCs Characterizegrowth potential Culture Test Chemotherapies CTCs Test CTCs for biomarkers 12 12
    13. Updated business canvas Consultation Characterization Provide new data Direct salesAdvocacy Groups Database building to improve ConferencesRegulatory R&D treatment MD office AdvertsAgency Oncologists decisions PublicationsOncologists Treatment PatientPhysicians Assoc determination in advertisements vitro Pharmaceutical Researchers IP Patient Database Hospital MD CLIA certification office, HMO Advocacy Groups PharmaVariable: Media, plastic ware, personnel, computing Service per time point (service/use)storage, building space Kits / Reagents (patients only)Fixed: Centrifuge, microscopes, freezers, incubators,and hoods 13 13
    14. Alternative market model • Urged by the teaching team to Private CMS payer/MAC explore alternative markets Hospital / Clinic • Interviewed clinical research Lab Advisory Commi ee Oncologists ASCO / organizations, pharma/biotech, NCCN and academics CanScanInfluencePaymentSets rate 14 14
    15. Alternative market model • Urged by the teaching team to explore alternative markets • Interviewed clinical research organization, pharma/biotech, and academics 15 15
    16. Partnering with Quest Diagnostics • Covers 130 countries • 2000 sites in the US 16 16
    17. Partnering with Quest Diagnostics 17 17
    18. Partnering with Quest Diagnostics 18 18
    19. Key people we spoke to: Dr. Ming Tong Dr. Brian Edmunds Dr. Philip Tagari Dr. Thomas Fare Dr. Sal Russelo Dr. Steve Labkoff Dr. Lisa Hewitt Dr. Zemin Zhang Dr. John Sninsky Dr. Scott Patterson Dr. Lawrence LaPointe Dr. Slyvie Sakata 19
    20. New opportunity: Pharmaceutical drug testing“A better human-like in vitro modelsfor high throughput screening” Head Research Development Amgen “This would be a powerful platform to test personalized drugs” VP Business Development“Testing drug on circulating cancer cells Merckcould offer us better end-points toevaluate drug candidate effectiveness” Head Research Development “Come work with us, we will be Abbott Laboratories your first customer!” CEO Clinical Genomics 20 20
    21. Pharmaceutical customer Low Barrier to Entry Quick Revenue 21 21
    22. Current business canvas Cell charact. Database dev. Provide new data PersonalStr. Alliances: Product/IP Dev to improve assistance,local hospitals - Treatment sel. treatment AutomatedMarin Gen Oncologists In vitro screening decisions. servicesHospital, CHRCOakland. Consultation Cell Line bank. Pharmaceutical Cancer drugMed Device – Researchers efficacy screening.Medtronic, Baxter IP CTC biomarkerTech Validation- discovery Patient Database Sales forceClinical Genomics CLIA certification CPT CodeJoint Venture:Quest DiagnosticsVariable: IP Licensing, lab supplies, personnel, IT, Usage fee per CTC scan, data/consultingspecimen transportation sales, cell line sales, instrument/kits productFixed: Lab equipment, lab space, SG&A, R&D model 22 22
    23. Intellectual property progress Who owns What is Patent New IP the IP? patentable ? process generationProgress Spoke to Berkeley Initial meeting with Provisional and New IP for keeping Tech Transfer IP lawyer Utility application competitors away Provisional Utility Application International Patent (US) Patents 12 months Up to 30 months 23 23
    24. Path to Revenues Mechanistic PoC Concept • Cell culture feasibility Validation • Mouse models ✓Requirements • 20-30 human blood samples • $10-15K Cost ($100K+ equip) • Access to lab Time 2-3 Months 24 24
    25. Path to Revenues Mechanistic Technology PoC Scope Concept • Cell culture • Proof of feasibility Concept in Validation multiple cancer types • Reproducibility • Mouse models • 100+ humanRequirements • 20-30 human blood samples blood samples • $10-15K • $50K+ Cost ($100K+ equip) • Incubator space • Access to lab Time 2-3 Months 3-6 Months 25 25
    26. Path to Revenues Mechanistic Technology Biomarker PoC Scope Validation Concept • Cell culture • PoC in multiple • CTC / tumor feasibility cancer types characterization Validation • Reproducibility • Mouse models • 100+ human • Genomic / PharmaRequirements • 20-30 human blood samples Proteomic blood samples • Morphology Sales • $10-15K • $50K+ • Outsource Cost ($100K+ equip) • Incubator space (~$20K) • Access to lab • Service/kit dev. Time 2-3 Months 3-6 Months 1-2 Months 26 26
    27. Path to Revenues Mechanistic Technology Biomarker Clinical PoC Scope Validation Validation Concept • Cell culture • PoC in multiple • CTC / tumor • Patient feasibility cancer types characterization stratification Validation • Reproducibility • Mouse models • 100+ human • Genomic / • Phase II trial ClinicalRequirements • 20-30 human blood samples Proteomic (~200 patients) blood samples • Morphology • Treatment use Sales • $10-15K • $50K+ • Outsource • Outsource Cost ($100K+ equip) • Incubator space (~$20K) ($500K-$1M) • Access to lab • Service/kit dev. • CPT Code/CLIA Time 2-3 Months 3-6 Months 1-2 Months 1-2 Years 27 27
    28. Financial / Operational Timeline 2012 2013 2014 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 1,200 1,000Cash Burn 800 ($‘000) 600 400 200 0Development Milestones Mechanistic PoC Incubator Space EquipmentRegulatory/IP Milestones Incorporate IP License Provisional Patent 28 28
    29. Financial / Operational Timeline 2012 2013 2014 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 1,200 1,000Cash Burn 800 ($‘000) 600 400 200 0Development Milestones Mechanistic PoC Technology Scope Incubator Space EquipmentRegulatory/IP Milestones Incorporate IRB IP License Provisional Patent 29 29
    30. Financial / Operational Timeline 2012 2013 2014 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 1,200 1,000Cash Burn 800 ($‘000) 600 400 200 0Development Milestones Biomarker Mechanistic PoC Technology Scope Validation Incubator Space Equipment Service DevelopmentRegulatory/IP Milestones Incorporate IRB CLIA IP License Provisional Patent 30 30
    31. Financial / Operational Timeline 2012 2013 2014 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 1,200 1,000Cash Burn 800 ($‘000) 600 400 200 0Development Milestones Biomarker Clinical Validation Mechanistic PoC Technology Scope Validation (Double-blind, placebo controlled Phase II) Incubator Space Pharma Sales Equipment Service DevelopmentRegulatory/IP Milestones Incorporate IRB CLIA CPT Cat III IP License Provisional Patent Patent Application Pat. Issue 31 31
    32. Choosing Partners: Decision Matrix LAB / Incubator Proof of Concept COST TIME IP issues ? 0 $ $ $$ $ Hospital Trial $$ $$$ 32 32
    33. Next Steps FDA Clinical Trials **Grants and Investments IP and Patents New IP Hospital trial generation Clinical **Grants and Validation Investments Personalized treatment of LAB patients Complete IP Publications protection Incorporating CanScan Proof of Concept New IP Revenue from **Grants and generation Pharma Investments Record of Invention Lab Certification Licensing New IP Patent filing (CLIA) royalties generationGrow cancer cells April 2012 May 2012 July 2012 Dec. 2012 Spring 2013 33 33
    34. Technology: Capture, Culture, Image CTCs 34 34
    35. Live cancer cells = Better prognostics? 35 35
    36. The CanScan Vision: Personalized DiagnosticsPlatform for:New drug testingPersonalizedChemosensitivitytestingBiomarkerDiscovery 36 36
    37. Thank you!James Lim, Ph.D., Nelson Chan, Ph.D., Dale Fedun, Brian FethMentor: John Feilders (CMEA Capital)Lawrence Berkeley National LaboratoryUniversity of California, Berkeley – Haas School of Business 37 37
    38. AppendixJames Lim, Ph.D., Nelson Chan, Ph.D., Dale Fedun, Brian FethMentor: John Feilders (CMEA Capital)Lawrence Berkeley National LaboratoryUniversity of California, Berkeley – Haas School of Business 38 38
    39. CanScan Technology: Background on CTCs Collection of cells that have the ability to ‘metastasize’ away from the primary tumor Enumeration of CTCs was a better indicator of disease progression than traditional imaging techniques CTCs are potentially a valuable diagnostic and prognostic tool 39 39
    40. Current CTC technologies: Limitations Competitors Marker-Dependent Marker- INDEPENDENT Method leads to Method allows for cell death LIVE cells to move and grow Genomic and Easy to enrich cells Proteomic analysis for genomic and is difficult proteomic analysis Technological Technological DEAD-END HIGHWAY 40 40
    41. Improving CTC detection and characterization Invade Current detection and characterization methods for CTCs fail to address the most intriguing aspect of their biology: Adhere CTCs are programmed to invade, adhere and Proliferate proliferate. 41 41
    42. CanScan Tech: substrates and imaging software 42 42
    43. Genomic Health: Historical Financials250 Profit200 Costs150 Revenues100 50 0 -50 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011-100-150-200-25080 Net Profit Funding Rounds60 Cash Flow4020 0 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011-20-40 43 43
    44. Health insurance reimbursement is necessary precondition for hospitals to use our service Private insurance or Medicare reimbursement requires: Evidence of • Double-blinded, placebo controlled clinical trial with several hundred participants will be needed Clinical Utility − Must demonstrate the detection is accurate and repeatable − Must demonstrate improved decision-making ability for physician linked to better patient outcomes Assignment of • Codes are assigned by the AMA (CPT code) and CMS (HCPCS code) semi-annually with editorial panel approval (12-18 mo) a Billing Code − CanScan’s likely coding: HCPCS Level II or CPT category III* − Veridex CellSearch received code in Nov. 2011 for CTCs − CanScan will likley need new code (non-immunologic)* Coding used for non-FDA approved service billed by suppliers other than physicians 44 44
    45. CMS requires that all laboratory testing on human specimens be CLIA certified • CMS regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA) − CLIA certification requires accreditation from a CLIA-certified provider (e.g., CAP) − CLIA covers approximately 5,500 independent labs (225,000 total labs) − We will likely need to apply for CLIA certification for High Complexity tests * • FDA regulates commercially marketed in vitro diagnostic tests under the Clinical Laboratory Improvement Amendments (CLIA), not a requirement for CanScan* Immunicon received approval as a High Complexity lab in 11/2006 45 45
    46. The market size for metastatic cancer diagnostics in the US is estimated to be $805 Million / year Methodology: Value: Explanation: Source: U.S. population size 313M  Total U.S. population in 2012  U.S. Census x Bureau estimate U.S. incidence of all cancers 0.512%  Treatment is typically given in  ACS Cancer Facts the first year following diagnosis & Figures 2011 = Total U.S. cancer incidence 1.6 M x % diagnosed with regional  Cancers that spread to local or  NCI SEER 2011 39.4% or distant cancers distant lymph nodes or organs data = Patients w/ regional or 628,420 distant cancers x Cost of diagnosis and  Weighted avg. patient cost p.a.  JAMA. 2010; $1,285 monitoring (annually) for imaging procedures (2008) 303(16):1625-1631 = Market size for metastatic $805M cancer Dx / monitoring 46 46
    47. Technology: Capture and Culture CTCs 1. Draw blood 2. Separate blood through centrifugation3. Plate cancer cells on S-SUBSTRATES, let them grow 4. Image cancer cells 47 47
    48. Technology: Enrichment and Selection Detailed comparison of CTCs from a single patient Determining the genetic and proteomic makeup of CTC subgroups 48 48

    ×