Qiagen N.v. · NYSE:QGEN
Qiagen — Investor Day (November 2016)
18 slides from Qiagen's investor day presentation, Nov 15, 2016
Slide 1: QuantiFERON-TB: Changing the way the world looks at TB prevention and elimination
QuantiFERON-TB: Changing the way the world looks at TB prevention and elimination Dr. L. Masae Kawamura, M.D. Senior Director, Medical & Scientific Affairs, TB Diagnostics November 15, 2016 Sample to Insight 2016 Analyst & Investor Day 1
Slide 2: Disclaimer
Disclaimer Safe Harbor Statement: This presentation contains both historical and forward-looking statements. All statements other than statements of historical fact are, or may be deemed to be forward looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended
Slide 3: Tuberculosis: A stealth foe and global killer
Tuberculosis: A stealth foe and global killer CAVITY – Millions to billions of bacilli Etiology Transmission Impact Global Incidence Non-motile slow Airborne disease A person dies of TB 10.4 million active growing bacteria every 18 seconds TB cases in 2015 May persist in the Spread mainl
Slide 4: The world is waking up to the importance of latent TB infection and prevention
The world is waking up to the importance of latent TB infection and prevention 2,000 1,770 1,600 Active TB case detection and treatment Cases per million 1,200 800 Mass LTBI detection 400 and treatment Active and latent TB 0 detection and treatment 2010 2020 2030 2040 2050 2015 Multiple studies show
Slide 5: Latent TB market endorsement: Scaling up the fight against latent TB
Latent TB market endorsement Scaling up the fight against latent TB 2015: UN approves global goal to reduce TB International guidelines expanding latent TB incidence by 80% by 2030 testing beyond developed countries 2014: WHO End TB Strategy: Prevention is an Targeting 115 countries with TB
Slide 6: Targeting high-risk groups for TB detection
Targeting high-risk groups for TB detection Disease progression TB infection and transmission Cumulative risks HIV infected Healthcare workers Immigrants with co-morbidities Immunosuppressive therapies Immigrants from high Diabetes Growing use of biologics TB-burden countries Tobacco
Slide 7: My patient did not know TB was preventable
My patient did not know TB was preventable Tuberculosis cases in San Francisco* 500 All cases With AIDS 1980: 494 400 Latent TB infection Destructive TB disease 300 My personal experience Dedicated my career to fighting TB 200 Director, TB Control in San Francisco 2010: 94 Lifelong TB educator
Slide 8: TB elimination requires accurate testing to reduce unnecessary healthcare costs
Classic TB screening algorithm TB symptom screen in high-risk person Yes (symptoms) No symptoms TST or IGRA Positive Negative Chest radiography TB and Any abnormality No abnormality other disease investigations Treat for LTBI TB elimination requires accurate testing to reduce unnecessary healthcare
Slide 9: Current diagnostic aids for TB detection rely on cellular immunity
FDA-approved TB diagnostic options Tuberculin skin test QuantiFERON-TB ELISPOT assay PPD ESAT-6, CFP-10, TB 7.7 ESAT-6, CFP-10 Cytokine induction PPD / M. tuberculosis specific antigen Calcineurin inhibitors: Impaired cytokine induction APC T-cell Lymphocyte-depleting agents: T-cell depletion End-st
Slide 10: TST least effective in most vulnerable: BCG-vaccinated and hard to reach
Tuberculin skin test (TST) QuantiFERON-TB (QFT) Manual placement, reading and data entry Can be fully automated Results affected by BCG vaccine and NTM Highly specific Two patient visits required, high no-show rate Results with one patient visit Significant inter-reader variability N
Slide 11: QuantiFERON-TB consistently shown as more specific and sensitive than TST
Sensitivity meta-analyses QFT TST Overlapping PPDs can affect TST results Sester et al. ERJ. 2011 80% 65% M. tuberculosis PPD Diel et al. Chest. 2010 – 84.5% 71.5% Developed country 255 19 62 Specificity meta-analyses QFT TST 8 Diel et al. ERJ. 2011 99.4% 88.7% 35 19 2 U.S. CDC Guidelines. 2010 99%
Slide 12: Current FDA-approved and CE-marked Interferon Gamma Release Assays
Current FDA-approved and CE-marked Interferon Gamma Release Assays QuantiFERON-TB Gold T-Spot® Objectivity No cell purification or counting Lab worker subjectivity in cell counting Spectrophotometer and software analysis Interpretation One cut-off point used worldwide Cut-off varies by cou
Slide 13: Changing perspectives on TB policy in China
Changing perspectives on TB policy in China 2015 Lancet ID: China's first multi-center population-based study of latent TB Head-to-head testing in the same 21,000 people Results: TST overestimated TB infection rates QuantiFERON-TB showed lower latent TB prevalence in China, impact on guideli
Slide 14: QuantiFERON-TB in New York City
QuantiFERON-TB in New York City Largest study ever involving QuantiFERON-TB 69,273 people tested (2006-2011 study) Goal: Better estimate background prevalence of TB Results: Positive QuantiFERON-TB data consistent with known TB risk factors – but half the rate with TST Conclusion: IGRAs li
Slide 15: IGRAs are key elements to policy development and TB elimination efforts
California TB control USPSTF guidelines 2,170 Californians with TB 10,000 TB suspect cases 20,000 contacts to cases 2.4 million with TB infection 38 million Californians Data provided by CDPH, 2013 IGRAs are key elements to policy development and TB elimination efforts Data provided by California De
Slide 16: QuantiFERON – the leading IGRA for TB detection
QuantiFERON – the leading IGRA for TB detection 1st generation 2nd generation 3rd generation 4th generation QuantiFERON®-TB QuantiFERON®-TB Gold QuantiFERON®-TB Gold QuantiFERON®-TB Gold Plus (liquid antigen) (QFT® in tube) (QFT®-Plus) Q4 2014: CE-IVD 2001: FDA approval 2004: FDA approval 2007: FDA
Slide 17: QuantiFERON-TB Gold Plus: Potential to better identify risk for progression
QuantiFERON-TB Gold Plus: Gaining attention in 2016 WHO TB report CD8 and CD4 T-cell response Current IGRA assays primarily detect a CD4 T-cell response. However, a new generation assay, the QuantiFERON-TB Plus (QFT- Plus, Qiagen, Hilden, Germany), has been developed to stimulate gamma interferon pr
Slide 18: TB remains a stealth foe and a global killer
TB remains a stealth foe and a global killer QuantiFERON-TB changing the way the world looks at TB prevention and elimination Leading IGRA test used to date in >30 million patients Key clinical benefits with new QFT 4th generation test Sample to Insight 2016 Analyst & Investor Day 18